TFS HealthScience

www.tfscro.com

1 Job

801 Employees

About the Company

TFS HealthScience is a full-service, global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance innovative treatments and improve patient outcomes. With operations across 40 countries, TFS and its strategic partners provide tailored strategic resourcing solutions and clinical development services in specialized therapeutic areas, including dermatology, internal medicine, neuroscience, oncology, and ophthalmology. Dedicated to empowering partners and enriching lives, TFS offers flexible solutions that combine global reach with the agility and responsiveness of a mid-sized CRO.

For more information, visit www.tfscro.com.

Listed Jobs

Company Name: TFS HealthScience
Job Title: Lead Clinical Research Associate
Job Description: Job title: Lead Clinical Research Associate Role Summary: Oversee site and country management for clinical trials, ensuring adherence to ICH/GCP, SOPs, and regulatory requirements. Support the Project Manager, lead and mentor CRAs, develop monitoring and site training plans, coordinate investigator meetings, and manage site and country reporting. Expectations: Deliver high‑quality monitoring and site management; maintain project timelines and budgets; ensure regulatory and protocol compliance; provide training and mentorship; adapt to shifting priorities and travel as needed. Key Responsibilities: - Supervise monitoring and site management activities, ensuring ICH/GCP compliance. - Train, mentor, and perform quality oversight of CRAs. - Develop and implement study monitor plans, site training plans, and verification initiatives. - Coordinate investigator meetings and prepare country/site reports. - Review monitoring reports, identify and resolve operational issues. - Serve as primary liaison with investigators and study teams. - Support recruitment, CRF completion guidelines, and monitoring/recruitment plans. - Assist Project Manager with tracking, monitoring plans, and resource management. Required Skills: - Minimum 3 years CRA experience with on‑site monitoring. - Strong knowledge of GCP, ICH guidelines, and clinical trial regulations. - Excellent written and verbal communication; proficiency in MS Office and electronic data capture systems. - Leadership and mentorship capabilities; strong organizational and line‑management skills. - Ability to work independently and within matrix teams; manage multiple projects. - Analytical, problem‑solving, and detail‑oriented. - Willingness to travel 10–20 %. Required Education & Certifications: - Bachelor’s degree in Life Sciences, Nursing, or related field (or equivalent). - CRA certification or equivalent training preferred (e.g., GCP certification, CRA‑specific certification).