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
- Clinical Research Scientist developing innovative breast cancer therapies at Lilly. Collaborating with cross-functional partners in clinical trial design and execution.
Responsibilities
- Contribute to the development and execution of clinical strategies for breast cancer programs.
- Maintain a focus on accelerating timelines while ensuring quality.
- Demonstrate compliance with procedures and be accountable for compliance of team members.
- Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports.
- Supervise and participate in medical monitoring activities, including data review, safety assessments, and protocol deviation management.
- Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence.
- Collaborate with Global Patient Safety on risk management planning.
- Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions.
- Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training.
- Participate in data analysis, scientific dissemination, and preparation of final study reports.
- Analyze and contextualize clinical data to support decision-making and portfolio strategy.
- Contribute to strategic planning and innovation through cross-functional working groups.
- Support planning and execution of symposia, advisory boards, and other external engagements.
- Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts.
- Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions.
Requirements
- PhD with 3+ years of industry experience OR BS Degree or equivalent experience in Health-related field with 10+ years’ industry experience
- 3+ years of clinical research scientist experience/clinical trial experience
- Direct Line Leadership experience
- Breast cancer disease state knowledge/experience
- An advanced health/medical/scientific graduate degree such as PharmD, PhD, MSN with advanced clinical specialty
- Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission.
- Proven strong communication, interpersonal, teamwork, organizational, and negotiation skills
- Demonstrated ability to influence others
Benefits
- Medical, dental, vision, and prescription drug benefits
- Flexible benefits (e.g., healthcare and/or dependent day care)
- Life insurance and death benefits
- Vacation benefits
- Employee assistance program
- Fitness benefits
- Employee clubs and activities
- Company-sponsored 401(k)
- Pension
Job title
Job type
Experience level
Salary
Degree requirement
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.