As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Responsibilities include, but are not limited to:
1. Trial and site administration:

• Track (e.g. essential documents) and report
• Ensure collation and distribution of study tools and documents

2. 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

3. 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

4. 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

5. S/AE Claim Management:

Support Financial Clinical Operation Manager(F-COM) for:

• Coordinate meetings
• Update and maintain tracking tools
• Develop and maintain settle agreements
• Coordinate for payments
• Collate, distribute/ship, and archive relevant documents

Qualifications, Skills& Experience
CORE Competency Expectations:

• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
• 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.
• ICH-GCP Knowledge appropriate to role
• Excellent negotiation skills for CTCs in finance area

Behavioral Competency Expectations:

• 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, both internally and externally.
• Able to work independently
• Proactive attitude to solving problems / proposing solutions

Experience Requirements:

• Minimum 1 - 2 years in Clinical Research or relevant healthcare experience

Educational Requirements:

• Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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