Senior Clinical Scientist

Job Overview:

The Clinical Scientist (CS) Provides ongoing in-depth analysis and scientific input into development and execution of protocols and clinical development plans by working with the medical/scientific/regulatory team to creatively solve a wide range of medical/scientific/clinical/regulatory problems. The CS works with the Medical Monitor/study support on a protocol/program basis for early clinical trials.

Summary of Responsibilities:

• Provides ongoing in-depth analysis and scientific input into development and execution of protocols and clinical development plans.
• Remains current on issues in scientific expertise through active, ongoing participation in relevant scientific meetings and courses.
• Works with the medical/scientific/regulatory team to creatively solve a wide range of medical/scientific/clinical/regulatory problems.
• Establishes and maintains close affiliations with the Fortrea and larger scientific community.
• Provides writing, review, editing and QC of applicable project documents, including: proposals, synopses, protocols, amendments, reports, narratives, investigator brochures, informed consent forms, manuscripts, clinical development plans and analysis plans that meet scientific and regulatory standards, as applicable.
• Provides scientific and logistical rationale/input for including biomarkers or other lab markers in Proof-of-Concept (POC) studies.
• Interacts with Fortrea Early Phase Development Solutions (EPDS) and participates on Molecule Development Teams as the early clinical representative.
• Oversee or assist in the planning and conduct of DSMB, Safety Review Committee, Cohort Review, Dose Escalation, Data Review or other medical-related study meetings.
• Writes draft Medical Responsibility, Safety and other related plans and facilitates their review and approval by Medical Monitor, Project Managers and Sponsors, as needed.
• Attends Kick-off Meetings and SIVs/Investigator Meetings. Supports training in key medical/scientific areas.
• Attends Team Meetings. Ensures that any medical/safety issues discussed at the meeting are resolved by the Medical Monitor in a timely manner.
• Serves as a resource for the Medical Monitor by tracking and reviewing ongoing studyspecific safety data (e.g., adverse events, vitals, ECGs and safety lab results) to identify safety trends.
• Acts as a liaison between the Medical Monitor in all communications between study sties, Fortrea project staff and Sponsors regarding protocol or other study-related questions, including documenting, tracking and follow-up on all issues.
• Supports CPS Medical Monitors in tracking and documenting any Inclusion/Exclusion criteria or protocol-related questions and answers.
• Supports the Medical Monitor in the review and interpretation of data from clinical studies, including data files, tables, figures and listings.
• Ensures SAEs are handled appropriately and in a timely manner. Supports Medical Monitor and Project Teams by reviewing SAE reports for completeness. Interacts with Fortrea/Sponsor/3rd Party safety groups, as needed to support SAE management.
• Participates in and/or leads process improvement initiatives such as establishing and improving document standards, documentation processes, developing new procedures, process mapping and SOP review/revision.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• Bachelor’s degree in an applicable scientific field, plus 10-12 years of relevant experience; or a Master’s degree in an applicable scientific field, plus 4-6 years of relevant experience; or a PhD degree in an applicable scientific field.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Knowledge of GCPs and regulatory agency guidelines.
• Ability to conduct limited review of related literature and references to obtain the required information and subsequently apply it.
• Skilled in data interpretation.
• Fluent in English, both written and verbal.

Experience (Minimum Required):

• Up to 10-15 years of relevant experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, or data management).
• Additional experience may be substituted for education requirements.

Physical Demands/Work Environment:

• Office working conditions.
• Overtime and weekend work as required.
• Travel Requirements less than 10% Regional.

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