Clinical Trial Coordinator (CTC)

MSD; Lima Metropolitana; On-site; PEN 60,000 - 90,000; Full time

Job summary

MSD Peru seeks a Clinical Trial Administrator to oversee comprehensive trial and site administration, prepare, collate, distribute and archive clinical documents, and support clinical and non-clinical supply management.

This role ensures site readiness, assists with IRB/ERC submissions, and collaborates with COM, CRM and CRA while coordinating with finance on CTRAs and payments.

Qualifications

• Experience in trial and site administration and clinical documentation.
• Familiar with CTRAs, budgets, contracts and payments.
• Knowledge of eTMF and CTMS is a plus.
• Collaborates with cross-functional teams (COM, CRM, CRA).

Responsibilities

• Budgeting, Agreement and Payments: collaborate with finance for budgets, contracts and payments.
• Develop, update and maintain country/site budgets and CTRAs.
• Track contract negotiations and maintain templates with Legal.
• Prepare submission materials for IRB/ERC and Health Authorities.
• Coordinate labeling changes and translation requests where applicable.

Job description

Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving 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.

Responsibilities include, but are not limited to:

Principal:

• 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

Desirable:

• 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, 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
  • 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