Senior Clinical Trial Coordinator (REMOTE)

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 Clinical Trial Coordinator 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 Clinical Operation Manager COM , Clinical Research Manager CRM and Clinical Research Associate CRA. And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.

The person acts as process Subject Matter Expert (SME), making recommendations for continuous improvement, providing training as appropriate/required and mentoring junior CTCs.

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

• 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:

• 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 Global Clinical Trial Operations (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 study memos/letters/protocols)

• Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

Quality & Oversight:

• Contribute …