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25 days old

Clinical Research Coordinator

Kelly Services
Charleston, SC 29409
Kelly Science & Clinical is searching for a full-time temp to hire **Clinical Research Coordinator** in **Charleston, SC.**


**Responsibilities will include:**


**Resource Allocation:**


1. Keep Medical Director informed of your workload.

2. If you have any extra time-whether anticipated or unanticipated-on daily or weekly basis-be prepared to help another coordinator.


**Regulatory:**


1. Submit initial regulatory submissions per sponsor instructions.

2. Submit ongoing regulatory reviews once study is up and running.

3. Submit SAEs, protocol deviations and revised 1572s to IRB as required.

4. Submit revised ICFs to IRB as needed.

5. Correctly file in regulatory binder.

6. Submit year 1 post study FDFs


**Study Conduction:**


1. Have in-depth understanding of own protocols.

2. Be prepared to assist when needed with other protocols (working

3. knowledge).

4. Ensure that source documents capture all information per protocol.

5. Attend initiation visits.

6. Attend investigators meetings as needed.

7. Ensure drug/supplies arrive in a timely manner prior to and during a study so as not to impede enrollment.

8. Review scheduled screens with recruiter to make sure inclusion/exclusion questions have been addressed prior to screening visit.

9. Ensure potential participant qualifies to consent (meets all inclusion/exclusion criteria prior to consenting).

10. Review all medications and medical history with patients at screening visit and update at all study visits.

11. Screen new subjects.

12. Strictly adhere to study protocol. Report any participant complaints or protocol deviations, errors, or violations to PI and possibly to sponsor and IRB.

13. Communicate with sponsor regarding patient or protocol questions.

14. Dispense study drug per protocol.

15. Maintain drug inventory logs.

16. Respond to data queries promptly.

17. Keep PI informed of lab abnormalities.

18. Meet with monitors.

19. Collect adverse event information from patients.

20. Ensure PI assesses all adverse events and determines causality.

21. Report all SAEs to PI promptly and collect data for submission to Sponsor and IRB in a timely manner.

22. Complete CRFs correctly and in a timely manner.

23. Sets up labs for next day.

24. Prepare all charts and CRFs ready for monitoring visit.


**Recruitment of Studies and Participants**


1. Whenever possible, review internal database to identify study


patients before enrollment starts. This prescreening should be done in conjunction with Recruiting Supervisor and with input from the Senior Director


1. Communicate with Recruiting Supervisor to meet or exceed goals

2. Own your studies-enrollment is ultimately your responsibility-come up


with creative recruitment ideas.


1. Communicate with monitors about upcoming studies that might be considered for.

2. Utilize investigator meetings as an opportunity to network and learn of


possible future study opportunities.


**General**


1. Follow all SOPs and the employee handbook; adhere to good clinical practices for research.

2. Be able to perform all duties of Research Assistant and Front Office Coordinator.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-10-01 Expires: 2021-11-01

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Clinical Research Coordinator

Kelly Services
Charleston, SC 29409

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