What are the responsibilities and job description for the Clinical Trial Coordinator-5 position at Parexel International Corporation?
Clinical Trial Coordinator (CTC)
Position Purpose:
The Clinical Trial Coordinator (CTC) is responsible for the following:
- Supports the Clinical Research Manager (CRM) and other team members through the life cycle of the study from study start up to study closure.
Primary Responsibilities:
- Trial and site administration:
- Tracking (e.g., essential documents) and reporting (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.
- Document management:
- Prepare documents and correspondence.
- Collate, distribute/ship, and archive clinical documents.
- Assist with electronic Trial Master File (eTMF) reconciliation.
- Updating manuals/documents (e.g., patient diaries, instructions).
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders.
- Execute eTMF Quality Control Plan.
- Obtain translations of documents.
- Regulatory & Site Start Up responsibilities:
- Provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions in a timely manner.
- Obtain, track and update study insurance certificates.
- Support preparation of submission package for Institutional Review Board (IRB) / Ethics Review Committee (ERC) and support regulatory agencies submissions.
- Publish study results for Global Clinical Trial Operations (GCTO) and Regulatory Affairs (RA) where required per local legislation.
- Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for:
- Development of country and site budgets (including Split site budget).
- Tracking and reporting of negotiations.
- Maintenance of tracking tools.
- Working knowledge of contract development, negotiation, approval, and maintenance (e.g., Clinical Trial Research Agreements (CTRAs)).
- Updating and maintenance of contract templates (in cooperation with Legal Department)
- Payment calculation and execution (investigators, vendors, grants)
- Ensuring compliance with financial procedures.
- Monitoring and tracking adherence and disclosures.
- Budget closeout.
- Obtain and process Foreign Corrupt Practices Act (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 where applicable).
- Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training.
- Adheres to EP and Client SOPs and processes.
Education and Certification:
- B.A./B.S. (Life Sciences preferred) or equivalent healthcare experience.
Skills and Experience:
- Minimum 1-2 years in Clinical Research or relevant healthcare experience.
Note - Specific experience requirements may vary depending on the Country - 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.
- International Committee on Harmonization (ICH) - Good Clinical Practice (GCP) knowledge appropriate to role.
- 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.
- Able to work independently.
- Proactive attitude to solving problems / proposing solutions.
- Positive mindset, growth mindset, capable of working independently with assigned tasks.
- Contributes to CTC team knowledge by acting as buddy /mentor and sharing best practices as appropriate/required.
Language Skills:
- Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
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