Clinical Scientist III (Remote)
- Reviews and evaluates CPS proposals and provides clinical and scientific support, as needed. This includes drafting study outlines/designs and providing guidance on early clinical development strategies.
- 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 Covance 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 Covance Early Phase Development Solutions (EPDS) and participates on Molecule Development Teams as CPS's representative on studies/programs.
- 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 & 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 study-specific 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, Covance 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 Covance/Sponsor/3 rd Party safety groups, as needed to support SAE management.
- Master's degree in an applicable scientific field, plus 4-6 years of relevant experience; or a PhD degree in an applicable scientific field.
- 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.
- About 7-10 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.
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