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see Standard of Evidence on page 5 »

December 23, 2019

Industry Briefs…2

Up and Coming…3

Drug & Device Pipeline News…8Twenty-six drugs and devices have entered a new trial phase this week.

JobWatch…10 Job listings and networking events.

see Ask the Experts on page 6 »

CenterWatchWeekly

The FDA’s Office of Good Clinical Practice responds to inquiries on a variety of trial-related subjects, providing

answers on the agency’s official regulations as well as best practices. The following is a selec-tion of questions and answers excerpted from the CenterWatch publication, GCP Questions, FDA Answers.

Question:A site on my study has an electronic

medical record (EMR) system but staff print copies of the records for the shadow chart for monitoring/auditing as the EMR system is not Part 11 compliant. The CRA has asked for the site to certify the copies and to look over the shoulder of the coordinator in order to confirm accuracy and completeness. However, the site will not allow the CRA to spot-check

their EMR, stating that their SOP does not allow this.

Can you offer specific guidance on how the FDA views this site’s policy?

Answer:Monitors will want to at least spot-check

the completeness of records at the source — the electronic database. How they view them is at your discretion, however. Either looking over the shoulder of a study staff member or having limited access is common.

The reason at least a spot-check is neces-sary is that the records can be selectively copied. If certified copies are used, they may not be complete records. The monitor is checking to ensure that study inclusion/exclusion criteria are met and that there are

Ask the Experts: CRA Role and Responsibilities

By Colin Stoecker

The FDA yesterday proposed broaden-ing its definition of the standard of evidence for effectiveness of inves-

tigational drugs and increasing the range of acceptable trial design, especially in rare disease research.

In its first updated guidance in more than 20 years on acceptable trial design, the FDA said substantial evidence from a trial proving effectiveness could be gained from one trial instead of two, one adequate well-controlled trial plus confirmatory evidence or reliance on a previous finding of effectiveness from an approved drug.

The FDA has decided that in some cases the traditional two-trial model can be replaced by other types of trial designs more

suited to the study of rare diseases. Although randomized, double-blinded, concurrently controlled superiority trials are regarded as the most rigorous trial design, five types of control are mentioned in the draft guidance: placebo, dose comparison, no treatment, ac-tive treatment and historical control.

“I think a lot of the reason [the FDA] issued it is because new therapeutic areas like rare diseases have led to situations where two trials aren’t needed,” Lindsay McNair, chief medical officer at WCG Clinical, said, adding that “one study might be more appropriate when the patient population is smaller, such as in rare diseases.”

But while the FDA may have been moti-vated by the needs of rare disease research,

Standard of Evidence Expanded in New FDA Guidance

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Industry Briefs

Stephen Hahn Sworn in as FDA CommissionerStephen Hahn was sworn in as the FDA’s 24th commissioner by HHS Secretary Alex Azar on Dec. 17.

During his confirmation hearing, the for-mer head of the MD Anderson Cancer Center voiced his support for faster approval of ge-nerics and vowed to ramp up drug approvals and innovation. He also suggested greenlight-ing more non-opioid treatments for pain as a way to help tackle the opioid epidemic.

Unlike many of his predecessors, Hahn lacks direct agency experience. But five for-mer commissioners wrote a letter to Congress in support of his confirmation. The former agency heads noted his seven-year tenure as the National Cancer Institute’s chief of pros-tate cancer and far-reaching clinical research experience in the public sector.

“I am a scientist and medical doctor and believe strongly in disciplined research, adher-ing to sound data and upholding the law,” Hahn said, in his first email to agency staff on Dec. 18.

Trump Signs Budget Package with Increased FDA Funding President Trump signed a fiscal 2020 federal budget package into law Friday that increases funding for the FDA for the third time in three years.

The budget includes $3.16 billion in appropriations for the agency, an increase of 3 percent on the fiscal 2019 allocation. Including user fees, the FDA’s total fiscal 2020 budget is $5.8 billion. Following two previous years of significant increases, the agency is no longer “running on fumes,” according to the Alliance for a Stronger FDA.

The budget expands funding for human drugs by $20 million to $683 million and for biologics by $12 million to $252 million. It also includes additional funding for advanced man-ufacturing, opioids and rare cancer therapies.

The agency also received additional funding for the 21st Century Cures Act of $5 million to $75 million.

One notable provision expands the definition of biosimilars to include “chemi-cally synthesized peptides” — a category that includes every type of insulin currently on the market. The expanded definition could open up the market for more insulin competitors and lower the drug’s price.

The provision “provides the potential for chemically synthesized follow-on insulins and other protein products to come to market through more efficient abbreviated pathways regardless of how they are manufactured,” an FDA spokesperson told CenterWatch Weekly.

The federal spending package passed the House 297-120 and the Senate 71-23 last week in an end-of-year scramble to meet a Dec. 20 deadline.

Sarepta Gets Approval on Rejected DMD DrugIn an about-face, the FDA has reversed its decision against Sarepta’s formerly rejected Duchenne muscular dystrophy (DMD) drug and granted accelerated approval for the therapy.

The drug, Vyondys 53, targets a specific DNA error occurring in only 8 percent of all Duchenne patients, and the FDA based its reversal on a small increase in an important muscle protein called dystrophin that is nor-mally missing in children with the disease.

The FDA previously rejected Vyondys 53 in August over the risk of infections related to infu-sion ports and kidney toxicity in animal studies.

Sarepta also ran into hang-ups with ad-verse event reporting during one of its trials for DMD. But Sarepta contested the FDA’s adverse event reporting submission on a patient

enrolled in its microdystrophin trial for DMD, saying that it had not reported any serious adverse events. The company later called the submission “erroneous” and continued the trial (CenterWatch Weekly, Nov. 15, 2019).

Sarepta has not yet proven that Vyondys 53 can improve muscle function or slow the progression of the disease.

Algorithm Accurately Predicts Odds of Drug Approval Researchers have developed a machine-learning algorithm that can predict a drug’s chances of regulatory approval, according to a recently published study in the Journal of Clinical Oncology Clinical Cancer Informatics.

Because oncology drugs are experiencing a decreasing rate of approval, researchers wanted to develop a tool that would predict the odds of approval for drugs in early phase trials. The result was RESOLVED2, a machine-learning algorithm whose key drivers are phase 1 clinical data, general pharmacologic data and the FDA’s approval timeline for drugs approved from 1972 to 2017.

Using the algorithm, scientists at the Gustave Roussy Institute, in Villejuif, France, and Paris-Sud University used data on an already approved drug to predict that it was 16 times more likely to be approved by the FDA than a nonapproved drug.

Six years of testing of the algorithm showed a high success rate: 73 percent of drugs predicted to be approved had been approved and 92 percent of drugs predicted to be nonapproved were still not approved.

see Industry Briefs on page 4 »

© 2019 CenterWatch. CWW2348

This feature highlights changes in clinical research organizations’ personnel.

Acceleron PharmaJay Backstrom has been named interim executive vice president of research and de-velopment for Acceleron Pharma. Backstrom previously served as vice president of global medical affairs and safety at Pharmion.

AlectorShehnaaz Suliman has been named presi-dent and chief operating officer of Alector. Su-liman brings experience from her previous role as senior vice president of corporate develop-ment and strategy at Theravance Biopharma.

Amylyx PharmaceuticalsAmylyx Pharmaceuticals has named Debra Canner as the company’s first global head of human resources. Canner was most recently appointed human resources consultant at CANbridge Pharmaceuticals.

Antares PharmaAntares Pharma has bolstered its leadership with the appointment of Edward Tykot as senior vice president. Tykot previously served as the vice president of business development at Nevekar.

Aro BiotherapeuticsScott Greenberg has been appointed vice president of business development and al-liance management at Aro Biotherapeutics. Greenberg was most recently the vice president and head of operations at Roivant Sciences.

Biofrontera Biofrontera has named Christopher Pearson as the new chief commercial officer. Pearson was most recently vice president of com-mercial strategy and development at Aldeyra Therapeutics since 2018.

BridgeBio PharmaBridgeBio Pharma has named Eli Wal-lace chief scientific officer in residence for

oncology. Wallace recently served as chief scientific officer at Peloton.

Bristol-Myers SquibbBristol-Myers Squibb has named Kathryn Metcalfe as the new executive vice president of corporate affairs and Tim Power vice presi-dent and head of investor relations. Metcalfe was most recently the chief communications officer of CVS Health. Power has been the lead for investor relations at Bristol Meyers Squibb since 2016.

Clarus TherapeuticsJay Newmark has been named chief medical officer, Frank Jaeger has been appointed chief commercial officer, Jose Luis Rodri-guez has been named the vice president of marketing, LaTonya Wright has been ap-pointed the vice president of sales, and James Holloway has been named vice president of manufacturing and supply at Clarus Thera-peutics. Newmark previously served as senior director of medical affairs at Genomic Health and OPKO Health. Jaeger was formerly the regional sales director at AbbVie. Rodriguez was formerly the head of the U.S. marketing oncology team for Astellas Pharmaceuticals. Wright was previously the regional sales director for Abbvie. Holloway was the lead for the research and development project man-agement office at the infection prevention franchise of CareFusion, now BD Medical.

Dynavax Technologies Ryan Spencer has been named chief ex-ecutive officer and David Novack has been named the chief operating officer of Dynavax. Spencer’s most recent appointment was as se-nior vice president of commercial for Dynavax. Novack was the global head of technical operation, supply chain for diagnostics, and the global head of manufacturing strategy for vaccines at Novartis.

EdgePoint AISteven King has been appointed prospective chief executive officer of EdgePoint AI, a division

of Mateon Therapeutics. King was previously the CEO of Peregrine Pharmaceuticals.

ElevateBioMelissa Carpenter has been appointed chief scientific officer of regenerative medicine at ElevateBio. Carpenter previously served as the vice president of research and development at NovoCell.

GrϋnenthalJan Adams has been named chief sci-entific officer at Grϋnenthal. Adams was previously the head of corporate strategy and portfolio management at Grϋnenthal before the promotion.

HemostemixBryson Goodwin has been named chief executive officer, Thomas Smeenk has been named the president, Natasha Server has been appointed the chief financial officer, and Yari Nieken will be appointed independent director for Hemostemix. Before joining Hemostemix, Goodwin was the managing director for Synergy Capital Market Advisors. Smeenk was most recently the president and CEO of Broadway Gold Mining. Server is a certified public accoun-tant. Nieken is the founder of Foremost Capital and was formerly an investment adviser at Union Securities.

LocanaLocana has expanded its senior management team with the appointment of James Burns as chief executive officer. Burns was most recently CEO of Casebia.

Nkarta TherapeuticsYvonne Li has been named senior vice president of finance and Brian Barnett has joined as vice president of clinical develop-ment at Nkarta Therapeutics. Li most recent-ly served as the vice president of finance and the principal financial and accounting officer for OncoMed Pharmaceuticals. Barnett was

WCG | CWWeekly December 23, 2019 3 of 10

Up and Coming

see Up and Coming on page 4 »

© 2019 CenterWatch. CWW2348

WCG | CWWeekly December 23, 2019 4 of 10

Novartis Hits a Wall in Phase 3 with Drug for AsthmaNovartis announced that it is dropping two phase 3 trials of an asthma drug, fevipip-rant (QAW039).

Even with the late phase failure of fevipiprant, Novartis is not giving up on its respiratory drug

pipeline as it continues to invest in other products, such as Xolair (omalizumab) and other phase 3 candidates, such as QVM149 and QMF149.

Janssen, PRA Launch All-Virtual Cardiac TrialJanssen and PRA Health Sciences are collabo-rating on one of the first fully virtual phase 3 trials for heart failure.

The trial, Canagliflozin: Impact on Health Status, Quality of Life and Func-tional Status in Heart Failure (CHIEF-HF), will evaluate the impact of Janssen’s Invokana (canagliflozin) on the quality of life improvement in patients with heart failure and type 2 diabetes. The trial will use wearable technology developed by PRA Health Sciences.

previously the chief executive officer and the chief medical officer at OncBioMune Pharmaceuticals.

Northwest BiotherapeuticsNorthwest Biotherapeutics has named Jean Davis chief financial officer, chief account-ing officer and interim chief information officer. Davis was formerly a risk advisory senior manager at BDO USA and is also a certified public accountant.

PMV PharmaceuticalsPMV Pharmaceuticals has appointed Leila Alland as chief medical officer. Alland last served as the CMO for Affimed.

Pyxis OncologyPyxis Oncology has announced a new addi-tion to its leadership team with the appoint-ment of Laura Sullivan as chief executive officer and director. Sullivan was previously the founder and president of SpringWorks Therapeutics.

Replimune GroupJean Franchi has been appointed chief finan-cial officer at Replimune Group. Franchi was previously CFO for Merrimack Pharmaceuticals.

Shattuck LabsShattuck Labs has appointed Casi DeYoung chief business officer. DeYoung formerly served as the chief operating officer at Im-muneSensor Therapeutics.

Translate BioFrank DeRosa has been appointed chief technology officer, Michael Heartlein has been named executive vice president, and Paul Burgess will become the chief operat-ing officer of Translate Bio. DeRosa was pre-viously senior director of preclinical research and process development at Shire. Heartlein was previously the chief technology officer and founder of Translate Bio. Burgess was the senior legal adviser for Scholar Rock, Civitas Therapeutics and BIND Therapeutics.

Zelluna ImmunotherapyZelluna Immunotherapy has appointed Namir Hassan as chief executive officer. Hassan joined Zelluna in 2018 as the chief scientific officer.

Industry Briefscontinued from page 2

Up and Comingcontinued from page 3

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This new edition of The CRC’s Guide to Coordinating Clinical Research is a one-volume training masterpiece that covers the roles and responsibilities of all key parties involved in managing clinical trials.

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© 2019 CenterWatch. CWW2348

WCG | CWWeekly December 23, 2019 5 of 10

Features

Standard of Evidencecontinued from page 1 The new draft guidance “makes

FDA’s thinking more transparent because sponsors can know what

FDA will consider rather than guess what they might accept.”

—Lindsay McNair, chief medical officer at WCG Clinical

McNair said, the guidance applies to all de-velopment programs. “Two randomized trials is still the baseline standard though,” McNair said, it’s just that the FDA has now said that sometimes one trial is okay.

Sponsors of “all products in develop-ment need to think about what to build for efficacy when they submit marketing applications,” McNair added. “It makes FDA’s thinking more transparent because sponsors can know what FDA will consider rather than guess what they might accept,” said McNair.

Some trial designs have different consid-erations for proving efficacy than others, for example, a lack of blinding when using no treatment control could introduce bias, the guidance says.

In addition, the guidance says, exter-nally controlled trials are usually reserved for specific circumstances, such as trials of diseases with high predictable mortality or progressive morbidity and trials in which the effect of the drug is self-evident, such as anesthesia.

Trial design alone, however, does not determine whether evidence from the trial is

enough to establish effectiveness. Another consideration of a well-designed trial is end-points, the guidance says.

The guidance discusses when it is ap-propriate to use the evidence from two trials vs. one trial plus confirmatory evidence or relying on previous findings of effective-ness of an already approved drug. However, FDA warns that there should be no single trial site that is the main contributor to the observed effect.

The agency will also allow for one trial plus confirmatory evidence to establish effective-ness and will consider factors, such as the per-suasiveness of the single trial, the robustness of the confirmatory evidence, the seriousness of the disease for an unmet need, the size of

the population and whether it is ethical to conduct more than one study.

An example of confirmatory evidence could be real-world evidence in a disease area or other trials in that area to show the lack of effect seen in a control group in a randomized trial.

The guidance gives four more examples of when a trial for a new drug could prove efficacy with only one study:

}} The trial is supported by effectiveness data of the drug from other closely related approved trials in the indication;

}} Supported by data that provides strong mechanistic support;

}} Data from the natural history of the disease; and

}} Effectiveness of other drugs in the same pharmacological class.

The substantial evidence for a new popu-lation, different dose, regimen or dose form could also be based on the FDA’s previous finding of effectiveness of an approved drug when it is scientifically and legally possible, the guidance says.

Comments on the draft guidance are due Feb. 21, 2020.

Read the draft guidance here: https://bit.ly/2PDLC1C.

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26 individual SOPs easily customized to match your culture and internal processes, including:

n Document development and change controln Assessing study feasibilityn Conflict of interest

n Records management, accountability & retentionn Investigational product managementn Protocol compliance

333

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UPDATED FOR 2019

To keep up with the always-evolving GCPs, your organization needs to spend valuable time updating or creating SOPs to reflect recent developments from the FDA.

We have done some of the work, so you do not have to.

STANDARD OPERATING PROCEDURES

FOR GOOD CLINICAL PRACTICE BY SITES

© 2019 CenterWatch. CWW2348

WCG | CWWeekly December 23, 2019 6 of 10

Features

Ask the Expertscontinued from page 1

“You would want to avoid any appearance of conflict of interest as the conflict may lead to intentional or

unintentional bias or errors.”

—FDA Office of Good Clinical Practice

no concomitant issues that would preclude the individual’s participation in the study or confound the results.

In general, during an inspection, the FDA usually reviews original (source) records or certified copies of clinical trial records. For example, during an inspection of a clinical investigator (CI), the FDA investigator will evaluate the CI’s practices and procedures to determine compliance with applicable regulations. Quite often, CIs maintain copies of certain records in their study files, e.g., records from a hospital or other institution that must maintain the originals.

The FDA refers to these as shadow files. While it is acceptable to keep shadow files in the study records, should the FDA conduct a bioresearch monitoring inspection of the study in question, the FDA investigator will expect to review at least a portion of the original source documents for such shadow files to verify their authenticity, even if the copies in the shadow files are certified as authentic copies.

I suggest you discuss with the site how you can bridge the gap between the research site and the monitor so that EMRs

can be viewed by you as well as the FDA, when appropriate.

Question:A CRO is proposing to offer support to sites

that are lacking resources by assigning its CRAs to conduct data entry at the site level.

Would this be considered a conflict of interest? Or is there a way to document that a CRA is at the site strictly to enter data that is backlogged?

Answer:While a CRO can employ monitors/CRAs

for their own studies, such individuals are usually in departments that are indepen-dent from those that are responsible for the conduct of the study. We therefore recom-

mend that the CRA not be someone who is participating in the conduct of the study.

You would want to avoid any appearance of conflict of interest as the conflict may lead to intentional or unintentional bias or errors in the clinical trial and may compro-mise the well-being of the human research subjects. The FDA would also recommend that the CRO have a specific SOP/policy that addresses this issue.

Additionally, the CRO operates on behalf of the trial sponsor and may have an interest in the sponsor (either through an equity interest or an interest in maintaining a business relationship with the sponsor). For example, the CRO has an interest in the timely completion of the clinical trial in order to meet the sponsor expectations and maintain the business relationship with the sponsor that would lead to more business for the CRO. This has the appearance of a conflict of interest.

You should check with your local and national laws and policies to see if there are any requirements related to conflict of inter-est and clinical trials.

For more information on GCP Ques-tions, FDA Answers, click here: https://bit.ly/2OFHCyT.

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For more than years we have overseen more research than all other IRBs combined.

Learn more about working with the gold standard in IRB review: www.wcgclinical.com/services/irb/

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WCG | CWWeekly December 23, 2019 8 of 10

Drug & Device Pipeline News

Company Drug/Device Medical Condition Status Sponsor ContactMeiji Seika Pharma Co.

DMB-3115 plaque psoriasis Phase 1 trial initiated in healthy subjects at one site in Europe

meiji.com

Alligator Bioscience ATOR-1017 cancer Phase 1 trial initiated dosing 50 subjects at three sites in Sweden

alligatorbioscience.com

MODAG anle138b multiple system atrophy and Parkinson’s disease

Phase 1 trial initiated enrolling healthy subjects

modag.net

Chondrial Therapeutics

CTI-1601 Friedreich’s Ataxia Phase 1 trial initiated dosing adult subjects over the age of 18 with Friedreich’s Ataxia

chondrialtherapeutics.com

NeuClone Pharmaceuticals

ustekinumab psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis

Phase 1 trial initiated dosing 210 subjects

neuclone.com

Arcus Biosciences

Genentech

AB928, regorafenib, and atezolizumab

colorectal and pancreatic cancer Phase 1/1b trial initiated in subjects with breast or ovarian cancer, gastroesophageal or colorectal cancer, lung cancer and advanced malignancies

arcusbio.com

gene.com

OBI Pharma OBI-999 cancer Phase 1/2 trial initiated enrolling subjects with solid tumors including gastric, pancreatic, colorectal and esophageal cancer at the University of Texas MD Anderson Cancer Center in Houston, Texas

obipharma.com

Zentalis Pharmaceuticals

ZN-c3 cancer Phase 1/2 trial initiated dosing two subjects with advanced solid tumors

zentalis.com

Akero Therapeutics AKR-001 non-alcoholic steatohepatitis Phase 2 trial initiated enrolled 80 subjects with non-alcoholic steatohepatitis at multiple centers

akerotx.com

DiaMedica Therapeutics

DM199 chronic kidney disease Phase 2 trial initiated dosing 60 African American subjects with hypertension and chronic kidney disease with IgA nephropathy

diamedica.com

Catabasis Pharmaceuticals

edasalonexent Duchenne muscular dystrophy Phase 3 trial initiated enrolled 131 boys affected by Duchenne muscular dystrophy ages 4 to 7 with any mutation type whom had not been on steroids for the previous six months at 37 sites in the United States, Canada, Europe, Israel and Australia

catabasis.com

Kamada inhaled Alpha-1 Antitrypsin

Alpha-1 Antitrypsin Deficiency Phase 3 trial initiated enrolling 250 subjects with AATD and moderate lung disease

kamada.com

Avadel Pharmaceuticals

FT218 Narcolepsy Phase 3 trial initiated enrolled 212 subjects with narcolepsy

avadel.com

Mycovia Pharmaceuticals

VT-1161 recurrent vulvovaginal candidiasis Phase 3 trial initiated enrolling 200 subjects with recurrent vulvovaginal candidiasis at 51 sites in the U.S.

mycovia.com

continues on next page »

For news on trial results, FDA approvals and drugs in development, Join the LinkedIn Drug Research Updates group!

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WCG | CWWeekly December 23, 2019 9 of 10

Drug & Device Pipeline News (continued from page 8)

Company Drug/Device Medical Condition Status Sponsor ContactCalliditas Therapeutics

Nefecon IgA nephropathy Phase 3 trial initiated enrolling 200 subjects with IgAN at approximately 140 sites in 19 countries

calliditas.com

Innovation Pharmaceuticals

Brilacidin ulcerative colitis Clinical Trial Authorization acceptance granted by the MHRA

ipharminc.com

Pfizer encorafenib in combination with cetuximab

colorectal cancer sNDA granted by the FDA pfizer.com

ITF Pharma TIGLUTIK Amyotrophic Lateral Sclerosis sNDA granted by the FDA itfpharma.comAmneal Pharmaceuticals

EluRyng generic version of NuvaRing aNDA granted by the FDA amneal.com

Daré Bioscience DARE-BV1 bacterial vaginosis IND approval granted by the FDA darebioscience.comZentalis Pharmaceuticals

ZN-c3 cancer IND Approval granted by the FDA

zentalis.com

Chondrial Therapeutics

CTI-1601 Friedreich’s Ataxia Fast-Track Designation and Rare Pediatric Disease Designation granted by the FDA

chondrialtherapeutics.com

Salarius Pharmaceuticals

seclidemstat Ewing sarcoma Fast Track Designation granted by the FDA

salariuspharma.com

Boston Scientific EXALT Model D single-use duodenoscope Clearance granted by the FDA bostonscientific.comAmarin Pharma Vascepa cardiovascular events FDA approval granted amarincorp.comPfizer Xeljanz ulcerative colitis Approval granted by the FDA pfizer.com

Instructions for auditing CROs, Clinical Sites and Central Testing Labs.In GCP Qualification Audits, Michelle Sceppa — a GCP consultant with more than 25 years of experience in quality assurance and regulatory compliance — lays out her approach to evaluating and selecting the best, most compliant and highest quality contractors to give your trial the best shot at success.

Learn what to look for in a compatible CRO and how to work with that partner to evaluate the trial sites and central testing laboratories that will do the hands-on work.n How to qualify CROsn How to work with CROs to audit sites and labsn How to use a risk-based approach to qualification auditsn What FDA and ICH guidances apply to GCP qualificationn What documentation to collect and how to create vendor filesn How to develop and use audit checklistsn How to assess a CROs overall effectiveness in conducting a study

Choosing Quality Contractors and Sites

GCP Qualification Audits

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WCG | CWWeekly December 23, 2019 10 of 10

Upcoming Event HighlightsThe Source for Clinical Research Jobs and Career Resources

More Jobs

[ V IE W ALL JOB L IS T INGS ]

Twice monthly, CWWeekly provides featured listings of clinical research job openings, upcoming industry conferences and educational programs from JobWatch, CenterWatch’s online recruitment website for both clinical research employers and professionals.

Jobs via Kelly Services

[ V IE W ALL KELLY SER V ICE S J OBS ]

Document ProcessorWestern Inst. Review BoardPuyallup, WA

Technology Product Technical WriterWIRB-Copernicus Group (WCG)Hamilton, NJ

Contracts ManagerWIRB-Copernicus Group (WCG)Princeton, NJ

Configuration AnalystePharmaSolutionsPlymouth Meeting, PA

Lab Director - Life Science LabRegenesis Biomedical, Inc. Scottsdale, AZ

Clinical Research Quality Management SpecialistGateway Institute for Brain Research Fort Lauderdale, FL

Director, Service EngagementWIRB-Copernicus Group (WCG)Hamilton, NJ

Clinical Project Manager ACI Clinical Bala Cynwyd, PA

Perm IP Clin Doc AnalystSacramento, CA

Statistician - NIH Baltimore, MD

Product Support Coordinator Palm Beach Gardens, FL

Patient Service Coordinator Franklin, TN

Clinic Scheduler Minneapolis, MN

Quality Control Associate Palo Alto, CA

Medical Technologist Austin, TX

Clinical Contracts AssociateSeattle, WA

Statistical Programmer Analyst South San Francisco, CA

Global Studies Manager II South San Francisco, CA

Medical Laboratory Technologist/CLS Menlo Park, CA

Clinical Project Associate Foster City, CA

Senior Statistical Programmer Emeryville, CA

Clinical Lab Specialist St Louis, MO

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F E B R UA R Y 1 2 , 2 0 2 0 INCREASE COMPLIANCE, RE-DUCE RISK WITH INTEGRATED DIGITAL SOLUTIONS: CREATE A CONNECTED SYSTEM AND STREAMLINE YOUR OPERATIONS

1:30 p.m. - 3:00 p.m. EST

Win that coveted first-to-market spot. When you integrate your digital solutions you’ll streamline operations, improve quality and mitigate risk. First-to-market is just around the corner.

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