Clinical Trial Coordinator- Finance- FSP

• Supports the Clinical Research Manager (CRM) and other team members through the life cycle of the study from study start up to study closure.

Organizational Relationships:

• Reports to Parexel assigned Line Management with day-to-day direction from Client. Refer to Organizational Chart for details regarding assigned role and associated reporting structure.

Primary Responsibilities:

• Trial and site administration:

o Tracking (e.g., essential documents) and reporting (e.g., Safety Reports).

o Ensure collation and distribution of study tools and documents.

o Update clinical trial databases (CTMS) and trackers.

o Clinical supply & non‐clinical supply management, in collaboration with other country roles.

o Manage Labeling requirements and coordinate/sign translation change request.

• Document management:

o Prepare documents and correspondence.

o Collate, distribute/ship, and archive clinical documents.

o Assist with electronic Trial Master File (eTMF) reconciliation. o Updating manuals/documents (e.g., patient diaries, instructions).

o Document proper destruction of clinical supplies.

o Prepare Investigator trial file binders.

o Execute eTMF Quality Control Plan.

o Obtain translations of documents.

• Regulatory & Site Start Up responsibilities:

o Provide to and collect from investigators forms/lists for site evaluation/validation, site start‐up and submissions in a timely manner.

o Obtain, track and update study insurance certificates.

o Support preparation of submission package for Institutional Review Board (IRB) / Ethics Review Committee (ERC) and support regulatory agencies submissions.

o 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:

o Development of country and site budgets (including Split site budget).

o Tracking and reporting of negotiations.

o Maintenance of tracking tools.

o Working knowledge of contract development, negotiation, approval, and maintenance (e.g., Clinical Trial Research Agreements (CTRAs)).

o Updating and maintenance of contract templates (in cooperation with Legal Department)

o Payment calculation and execution (investigators, vendors, grants

o Ensuring compliance with financial procedures.

o Monitoring and tracking adherence and disclosures.

o Budget closeout.

o Obtain and process Foreign Corrupt Practices Act (FCPA) documentation in a timely manner.

• Meeting Planning:

o Organize meetings (create & track study memos/letters/protocols).

o 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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