FSP Sr. Clinical Scientist - Immunology
Fortrea
Summary
Position leads Phase 1-3 Clinical Trials and oversees medical monitoring. This is not a laboratory/research scientist role.
Job description
In this role, the selected candidate will lead/support studies; be accountable for the clinical/scientific execution of the protocol; be the clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites); and act as scientific lead on Clinical Trial Team (CTT).
Responsibilities include:
- Responsible for trial design and endpoint development in collaboration with CD; collaborates with medical writing to develop trial results communication for investigators
- Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports, monitoring data issues and central lab reports
- Sets up/supports SAC, DMC, adjudication committee; provides scientific input to SM for data management activities (e.g. EDC, DRP, CRF's)
- Protocols/amendments – collaborates with medical writing, participates in governance committee review; authors protocol clarification letters; reconciles and reviews all protocol deviation classifications and assess and prepares protocol deviation list for the CSR
- May act as mentor to other Clinical Scientists
Requirements:
Education:
- Degree in Life Sciences or significant experience in clinical development (>14 years)
- BS/BA with 7+ yrs clinical research experience
- MS/PhD with 5+ years clinical research experience
Experience:
- Minimum 2 years pharmaceutical and clinical drug development experience in a Clinical Scientist role as a lead required.
- Proven ability to effectively manage multiple complex studies
- Medical monitoring experience required
- TA-specific experience in Immunology
- Excellent Excel and PP skills required
- Excellent written and oral communication skills
Requirements
- Degree in Life Sciences or significant experience in clinical development (>14 years)
- BS/BA with 7+ yrs clinical research experience
- MS/PhD with 5+ years clinical research experience
- Minimum 2 years pharmaceutical and clinical drug development experience in a Clinical Scientist role as a lead required
- Proven ability to effectively manage multiple complex studies
- Medical monitoring experience required
- TA-specific experience in Immunology
- Excellent Excel and PP skills required
- Excellent written and oral communication skills
Company overview
Fortrea Holdings Inc. is a leading global contract research organization (CRO) that provides comprehensive clinical development solutions to the pharmaceutical, biotechnology, and medical device industries. Headquartered in Durham, North Carolina with operations in over 90 countries, Fortrea specializes in managing all aspects of clinical trials from Phase I through IV, including clinical pharmacology and post-approval services. The company offers a wide range of services including regulatory affairs, protocol design, operational planning, patient recruitment, project management, data management, biostatistics, pharmacovigilance, and medical writing. With over 30 years of clinical research experience, Fortrea has evolved from its heritage as Covance and Labcorp into a pureplay CRO focused on delivering agile, fit-for-purpose solutions for both emerging and established life sciences companies. The company has conducted more than 5,850 clinical trials involving over 1 million subjects in the past five years, with particular expertise in oncology, central nervous system disorders, rare diseases, and cell and gene therapies.