MSD Clinical Trial Coordinator 

India 

59704387

Job Description

Clinical Trial Coordinator

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 o Clinical supply & non-clinical supply management, in collaboration with other country roles.
• Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)

Document management:

• Prepare documents and correspondence.
• Collate, distribute/ship, and archive clinical documents, e.g. eTMF
• Assist with eTMF reconciliation o Execute eTMF Quality Control Plan o Update manuals/documents (e.g., patient diaries, instructions) o 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 siteevaluation/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.

Budgeting, Agreement and Payments:

• Collaborate with finance/budgeting representatives for:
• Develop, control, update and close-out country and site budgets (including Split site budget) Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
• Track and report contract negotiations
• Update and maintain contract templates (in cooperation with Legal Department)
• Calculate and execute payments (to investigators, vendors, grants)
• Ensure adherence to financial and compliance procedures.
• Monitor and track adherence and disclosures
• Maintain tracking tools.
• Obtain and process FCPA documentation in a timely manner.

Meeting Planning:

• Organize meetings (create & track studymemos/letters/protocols)
• Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

Skills:

• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills.
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
• Hands on knowledge of Good Documentation Practices
• Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
• ICH-GCP Knowledge appropriate to role • Excellent negotiation skills for CTCs in finance area
• Effective time management, organizational and interpersonal skills, conflict management
• Effective communication with external customers (e.g. sites and investigators)
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus, both internally and externally. Able to work independently.
• Proactive attitude to solving problems / proposing solutions.
• Positive mindset, growth mindset

Qualification & Experience:

• Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree

Current Contingent Workers apply

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

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.