Clinical Trial Coordinator

Parexel FSP is looking for a Clinical Trial Coordinator! This position is remote and anywhere in the United States.

Job Title: 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.

Organizational Relationships:

• Reports to ExecuPharm (EP) 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.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.