Clinical Trial Coordinator Intern
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Salary Not Disclosed
1 Vacancy
Job Description
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 COM Lead/COMs and CTCs the person prepares collates distributes and archives clinical documents. The Interns supports clinical supply & nonclinical supply management and ensures timely maintenance of tracking and reporting tools as applicable.
* Internship duration up to 12 months *
Responsibilities:
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 & nonclinical 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 StartUp responsibilities: Collaborate with other country roles to:
In a timely manner provide to and collect from investigators forms/lists for site evaluation/validation site startup 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:
B.A./B.S. (Life Science preferred) or equivalent healthcare experience.
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
Current Employees apply HERE
Current Contingent Workers apply HERE
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 preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
Intern/Coop (Fixed Term)Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
05/26/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
IC
Employment Type
Full-Time
