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Clinical Research Coordinator

Activmed Practices and Research


Location:
Portsmouth, New Hampshire
Date:
06/01/2017
2017-06-012017-07-01
Job Status:
Full Time
Categories:
  • Clinical Operations
Activmed Practices and Research
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  • Research Salary

Job Details

Summary – Conducts clinical research trials in a professional manner according to GCP and ActivMed SOPs.

Required Work Experience:

  • At least 1 year experience as a Clinical Research Coordinator or at least 2 years experience as a Clinical Research Assistant at a research site working with human participants.

Duties and responsibilities :

  • Responsible for start up activities including delegation logs, training logs, SIV, etc.
  • Responsible for filing of study material in source docs and regulatory binders.
  • Identification and recruitment of potential study subjects.
  • Maintain recruitment portals and screening binders.
  • Review subjects’ medical records and medical histories to determine study eligibility.
  • Understand and follow assigned protocols.
  • Discuss and present informed consent to potential subjects.
  • Obtain appropriate signatures throughout the trial.
  • Perform all study visits according to protocol and GCP guidelines.
  • Follow physician instructions to ensure proper subject care.
  • Obtain physician signatures on all labs and ECGs promptly.
  • Inform subjects of any health related issues and recommendations to follow up with subject’s health care provider.
  • Document carefully and with detail all study related information including instruction from PI and Sub-I related communication with subject and any events relating to protocol.
  • Take all appropriate action to insure subject safety.
  • Prepare for monitor visits – verify source – ensure all data is complete and entered into EDC. Resolve all queries.
  • Maintain and organize drug cabinet, study visit kits, lab area and exam rooms.
  • Meet and work with CRA to correct data on the day of monitoring visit.
  • Assure that all subject information is entered completely and accurately into patient database for consideration in future trials.
  • Perform all necessary clinical procedures such as ECG, phlebotomy, vitals, etc.
  • Manage scheduling and appropriate planning of subject visits, windows, and physician availability.
  • Facilitates training of all applicable personnel.
  • Oversees any work by the research assistant or other personnel involved in the trial.

Job Type: Full-time