Clinical Trial Coordinator

ExecuPharm/Parexel FSP is currently looking for a full time Clinical Trial Coordinators to work on assignment for our client REMOTELY.

ongoing assignment

salary, full benefits, 401K, Paid time off/SICK/Vacation

B.A./B.S. (Life Science preferred) or equivalent healthcare experience

Minimum 1‐2 years in Clinical Research or relevant healthcare experience

Trial and site administration:

Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)

Ensure collation and distribution of study tools and documents

Update clinical trial databases (CTMS) and tracker

Clinical supply & non‐clinical supply management, in collaboration with other country roles

Manage Labeling requirements and coordinate/sign translation change request

Document management:

Prepare documents and correspondence

Collate, distribute/ship, and archive clinical documents

Assist with eTMF reconciliation, Updating manuals/documents (e.g., patient diaries, instructions)

Document proper destruction of clinical supplies

.Prepare Investigator trial file binders, Execute eTMF Quality Control Plan

Obtain translations of documents

Regulatory & Site Start‐Up responsibilities:

In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start‐up and submissions

Obtain, track and update study insurance certificates

Support preparation of submission package for IRB/ERC and support regulatory agencies submissions. Publish study results for GCTO and RA where required per local legislation

#INFSPQualificationsExecuPharm/Parexel FSP is currently looking for a full time Clinical Trial Coordinators to work on assignment for our client REMOTELY.

ongoing assignment

salary, full benefits, 401K, Paid time off/SICK/Vacation

B.A./B.S. (Life Science preferred) or equivalent healthcare experience

Minimum 1‐2 years in Clinical Research or relevant healthcare experience

Trial and site administration:

Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)

Ensure collation and distribution of study tools and documents

Update clinical trial databases (CTMS) and trackers

Clinical supply & non‐clinical supply management, in collaboration with other country roles

Manage Labeling requirements and coordinate/sign translation change request

Document management:

Prepare documents and correspondence

Collate, distribute/ship, and archive clinical documents

Assist with eTMF reconciliation, Updating manuals/documents (e.g., patient diaries, instructions)

Document proper destruction of clinical supplies

.Prepare Investigator trial file binders, Execute eTMF Quality Control Plan

Obtain translations of documents

Regulatory & Site Start‐Up responsibilities:

In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start‐up and submissions

Obtain, track and update study insurance certificates

Support preparation of submission package for IRB/ERC and support regulatory agencies submissions. Publish study results for GCTO and RA where required per local legislation

#INFSPEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.