Job Description
Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration. The role will collaborate at local level closely with CRA and CTC.
Responsibilities include, 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
Document management:
Prepare documents and correspondence
Collate, distribute/ship, and archive clinical documents, e.g. eTMF
Assist with eTMF reconciliation
Prepare Investigator trial file binder
Meeting Planning:
Organize meetings (create & track study memos/letters/protocols)
Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
Support Local initiatives:
Create posters and videos
Improvement in local process using technologies such as automation, coding, AI
With oversight of Sr.CRA/CRA and/or CRA-Manager, support site management as appropriate including but not limited to:
Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
Assist site visits as appropriate including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
COMPETENCY EXPECTATIONS:
Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.
Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
Knowledge of Good Documentation Practices.
Understanding and developing skills in Site Management including management of site performance and patient recruitment.
Developing level of monitoring skill and independent professional judgment.
Good IT skills such as automation, video editing, coding, AI.
BEHAVIORAL EXPECTATIONS:
Effective time management, organizational and interpersonal skills, conflict management
Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.
High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.
Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
Demonstrates commitment to Customer focus.
Required Skills:
Competency Management, Competency Management, Conflict Management, Cultural Awareness, Customer Centricity, Customer-Focused, Database Management, Data Documentation, Data Entry, Decision Making, Document Management, Email Management, Event Planning, File Management, Inventory Management, Line Management, Matrix Management, Meeting Facilitation, Meeting Management, Meeting Organization, Minute Taking, Multitasking, Office Management, On Site Management, Payment Handling {+ 8 more}Preferred Skills:
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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:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
12/30/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
