SENIOR CLINICAL TRIAL COORDINATOR

Job Description This role is responsible for comprehensive trial and site administration.
Under the oversight of the Senior COM or COMs or CTC Manager, the person prepares, collates, distributes and archives clinical documents.
The CTC supports clinical supply & non -clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.
The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB /ERC and Health Authorities.
The role will collaborate at local level closely with COM, CRM and CRA.
And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.
Current Employees apply HERE Current Contingent Workers apply HERE Secondary Language(s) Job Description.
Responsibilities include, but are not limited to.
• Trial and site administration.
o Track (e.
.
essential documents) and report (e.
.
Safety Reports) o Ensure collation and distribution of study tools and documents o Update clinical trial databases (CTMS) and trackers o Clinical supply & non -clinical supply management, in collaboration with other country roles o Manage Labeling requirements and coordinate/sign translation change request • Document management.
o Prepare documents and correspondence o Collate, distribute/ship, and archive clinical documents, e.
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eTMF o Assist with eTMF reconciliation o Execute eTMF Quality Control Plan o Update manuals/documents (e.
., patient diaries, instructions) o Document proper destruction of clinical supplies.
o Prepare Investigator trial file binders o Obtain translations of documents • Regulatory & Site Start -Up responsibilities.
Collaborate with other country roles to.
o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start -up and submissions o Obtain, track and update study insurance certificates o Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
o Publish study results for GCTO and RA where required per local legislati on Search Firm Representatives Please Read Carefully  Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.
Where agency agreements are in place, introductions are position specific.
Please, no phone calls or emails.
Employee Status.
Regular Relocation.
Domestic VISA Sponsorship.
Travel Requirements.
Flexible Work Arrangements.
Hybrid Shift.
Valid Driving License.
Hazardous Material(s).
Requisition ID.
R