Description of Roles and 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 documentso Update clinical trial databases (CTMS) and trackerso Clinical supply & non-clinical supply management, in collaboration with other country roleso Manage Labeling requirements and coordinate/sign translation change request• Document management:o Prepare documents and correspondenceo Collate, distribute/ship, and archive clinical documentso Assist with e TMF reconciliationo Updating manuals/documents (e.g., patient diaries, instructions)o Document proper destruction of clinical supplies.o Prepare Investigator trial file binderso Execute e TMF Quality Control Plano Obtain translations of documents• Regulatory & Site Start-Up responsibilities:o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissionso Obtain, track and update study insurance certificateso Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.o Publish study results for GCTO and RA where required per local legislation• Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for:o Develop country and site budgets (including Split site budget) o Tracking, and reporting of negotiationso Maintenance of tracking toolso Contract development, negotiation, approval and maintenance (e.g.

CTRAs)o Update and maintain contract templates (in cooperation with Legal Department)o Payment calculation and execution (investigators, vendors, grants)o Ensure compliance with financial procedures ,o Monitor and track adherence and disclosureso Budget closeout o Obtain and process 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 vendor where applicable)• Contributes strongly to CTC team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.• Mentors / buddies junior CTCs on process requirements Experience Required Minimum 3-5 years in Clinical Research or relevant healthcare experience Educational Requirements B.

A./B. S.

(Life Science preferred) or equivalent healthcare 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 Behavioural Competency Expectations• Highly 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 taking full ownership of delegated tasks• Proactive attitude to solving problems / proposing solutions• Positive mindset, growth mindset• Contributes to CTC team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required 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.