Clinical Trial Coordinator Intern

Job Description

The internship program provides learning experience, mentoring and valuable work experience in the field of clinical trials. We provide our interns the opportunity to work on meaningful assignments and make sure that they gain real world experiences (in the areas of Regulatory & Finance and Supply & CRA support).

This program provides comprehensive trial and site administration experience. Under the oversight of the Sr.COM/COMs and CTC’s, the person prepares, collates, distributes and archives clinical documents. The Interns supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.

During this program you will learn and experience the following, but are not limited to:

Trial and site administration:
Track (e.g. essential documents) and report (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, e.g. eTMF
Assist with eTMF reconciliation
Execute eTMF Quality Control Plan
Update manuals/documents (e.g., patient diaries, instructions)
Document proper destruction of clinical supplies.
Prepare Investigator trial file binders
Obtain translations of documents
Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:
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.

Requirements:

·Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills.

·Effective time management, organizational and interpersonal skills, conflict management

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

·GCP course/ CRA course

*Internship duration – up to 12 months

Current Employees apply HERE

Current Contingent Workers apply HERE

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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:

Intern/Co-op (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R291886