Global Clinical Development Associate
hace 1 semana
About the Role
TFS HealthScience, a leading global Contract Research Organization (CRO), seeks an experienced Global Clinical Development Associate - Oncology Studies to join our team. This role involves working with biotechnology and pharmaceutical companies on their entire clinical development journey.
Key Responsibilities:
- Clinical Trial Monitoring: Conduct on-site and remote monitoring of clinical trials in accordance with TFS and/or client company Standard Operating Procedures, FDA regulations, and GCP and ICH guidelines.
- Data Review and Queries: Review CRFs (paper or electronic) and subject source documentation for validity and accuracy, generate queries to investigational sites/clients to resolve problem data.
- Site Issues Resolution: Identify site problems/deficiencies, report to management through trip reporting, memos, and verbal communication with Project Manager or Lead CRA.
- Corrective Actions: Initiate corrective action to resolve issues as directed by supervisor.
- Regulatory Compliance: Contribute to the completion of the application to Ethics Committee/IRB, prepare necessary documentation enclosed to the application according to local requirements in cooperation with CTA and directed by Lead CRA/Project Manager.
- Contract Handling: Participate in contract handling and negotiation directed by Lead CRA/Project Manager.
- Study Setup: Set up ISF and SMF (or cooperate with CTA) and distribute to the investigational sites.
- Supply Management: Order, ship, and reconcile clinical investigative supplies for study sites, if applicable.
- Status Reporting: Prepare and submit status reports as directed by Lead CRA/PM.
Requirements:
- Education: Bachelor's Degree, preferably in life science or nursing or equivalent.
- Experience: Minimum 4 years of experience working as a CRA.
- Oncology Expertise: Experience in oncology studies.
- Communication Skills: Excellent written and verbal communication skills.
- Organizational Skills: Excellent organizational skills.
- Travel Requirements: Able to work independently as well as in a team matrix organization, with occasional travel up to 60-70%.
What We Offer:
- Competitive Salary: $85,000 - $110,000 per annum, depending on experience.
- Benefits Package: Comprehensive benefits, including health insurance, flexible remuneration, overtime compensation, summer working hours, and flexibility.
About Us:
TFS HealthScience is a full-service, global Contract Research Organization (CRO) with over 27 years of experience. Our core values of Trust, Quality, Passion, Flexibility, and Sustainability drive our decision-making process. With over 800 professionals worldwide, we deliver tailored clinical research services across key therapeutic areas, including Dermatology, Neuroscience, Oncology, and Ophthalmology.
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