Research Coordinator overseeing clinical studies for musculoskeletal injuries in military health. Assisting with project planning and coordination while ensuring compliance with protocols and regulations.
About the role
- Oncology Late Stage Clinical Scientist responsible for scientific oversight and data integrity of clinical trials. Collaborating with clinical and medical teams to implement and execute clinical studies in Oncology.
Responsibilities
- Responsible for scientific oversight, data integrity and quality of clinical trial(s)
- 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
- 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 2 years Clinical Research experience in industry/CRO, OR MS in a relevant Science discipline and minimum of 5 years of Clinical Research experience in industry/CRO OR BA/BS in a relevant Science discipline and minimum of 7 years Clinical Research experience in a similar role in industry/CRO
- Clinical Research experience in the phase 3/pivotal space in Oncology
- 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
- Effective communication, presentation, and organizational skills
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 including medical, prescription drug, dental and vision coverage
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Overseeing and administering clinical research studies and managing study budgets for military health research. Coordinating project planning and ensuring compliance with regulatory requirements.
Senior Biostatistician coordinating clinical trials at Parexel. Leading project teams and ensuring statistical quality in clinical research.
Centralized Clinical Trial Manager at ICON responsible for reviewing clinical trial site visit reports and ensuring quality standards. Act as a liaison for timely resolution of issues.
Clinical Research Nurse Coordinator managing clinical research operations at Duke's Trauma, Acute & Critical Care Division. Supervising nursing care and ensuring accuracy in data management.
Clinical Research Coordinator managing clinical trials at Emory University. Overseeing research projects, providing guidance, and ensuring compliance with protocols and regulations.
Senior Clinical Trial Manager managing Phase 1 clinical research studies and collaborating with cross - functional teams in a global biopharmaceutical environment.
HR Manager for Clinical Research Units lead engagement strategies at Fortrea. Partnering closely with site leadership in clinical environments in Dallas, TX or Madison, WI.
Clinical Trial Manager overseeing clinical trials managing operations and compliance in Brazil at IQVIA. Ensuring adherence to protocols and managing country - specific requirements.
Feasibility Manager evaluating clinical trial sites to advance pipeline and create strategic partnerships. Play a pivotal role in bringing clinical trials to life in Argentina.