Clinical Research Coordinator II at University of South Florida responsible for coordinating clinical research activities and ensuring participant data quality. Serving as main contact for sponsors and patients for specific research protocols.
About the role
- Oncology Late-Stage Clinical Scientist ensuring data integrity and quality in clinical trials. Collaborating with cross-functional teams for successful implementation in the oncology portfolio.
Responsibilities
- Responsible for scientific oversight, data integrity and quality of clinical trial(s)
- Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
- Effectively partner with other clinical and medical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program
- Represent the study team in governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy
- Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents
- Set the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends
- In close partnership with medically qualified colleague/s, analyze the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s)
Requirements
- PhD/Pharm D in a relevant Science discipline and minimum of 5 years Clinical Research experience in industry/CRO, OR MS in a relevant Science discipline and minimum of 7 years Clinical Research experience in industry/CRO OR BA/BS in a relevant Science discipline and minimum of 10 years Clinical Research experience in a similar role in industry/CRO
- Clinical Research experience in the phase 3/pivotal space in Oncology, ideally on the side of the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval
- Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations
- Extensive understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance
- Experience working on large data sets
- Proficiency with Microsoft Office and relevant scientific software
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits to include medical, prescription drug, dental and vision coverage
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