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Lead Clinical Research Specialist
2 months ago
The Lead Clinical Research Specialist is responsible for overseeing the daily functions associated with the management of clinical trial operations at the site level. This role involves direct engagement with study participants to ensure their eligibility and secure informed consent in accordance with the clinical trial protocol.
Key Responsibilities- Operational Management: Directly manage and supervise the daily activities related to clinical trials, ensuring compliance with all regulatory requirements.
- Participant Interaction: Regularly communicate with current and prospective clinical trial participants to assess eligibility and facilitate the consent process.
- Standard Operating Procedures: Develop and implement standard operating procedures that comply with all relevant regulations, including those set forth by the FDA and OHRP.
- Staff Training: Contribute to the training and development of clinical trial personnel, ensuring adherence to operational protocols.
- Primary Contact: Serve as the main point of contact for participants, providing updates on study progress and coordinating with other team members as necessary.
- Scheduling and Troubleshooting: Manage participant visit schedules and address any technical issues, escalating them to the appropriate personnel when needed.
- Safety Monitoring: Collect and document information regarding safety events, preparing necessary documentation for review.
- Data Management: Ensure accurate and timely collection, documentation, and reporting of data in both Sponsor and Client databases.
- Regulatory Support: Assist regulatory staff in maintaining essential regulatory documents in line with Client SOPs and applicable regulations.
- Team Communication: Effectively communicate specific study requirements to the research team and external stakeholders.
- Study Oversight: Maintain regular communication with the Principal Investigator and study team to review study progress and address any issues.
- Supply Management: Oversee the management of study supplies and participant stipends.
- Credentialing: Ensure that all study team members are appropriately credentialed and trained.
- Meeting Facilitation: Organize and facilitate meetings with study monitors, auditors, and investigators.
- Issue Resolution: Ensure timely responses to queries and documentation of any study-related issues.
- Product Management: If applicable, manage the distribution of investigational products and provide patient education regarding their administration.
- Process Improvement: Contribute to the development and implementation of tools and processes to enhance clinical study administration.
- Compliance Accountability: Ensure site compliance with subject safety reporting and escalate issues as necessary.
- Professionalism: Demonstrate professionalism and apply leadership practices in all aspects of the role.
- Team Support: Train and support study team members on effective communication and teamwork practices.
- Trial Execution: Conduct all trial visits and complete study-specific assessments, including vital signs and sample processing.
- Data Entry: Enter data into sponsor EDC systems and resolve any queries.
The ideal candidate will possess a strong understanding of clinical protocols and demonstrate the ability to work independently as the sole Lead Clinical Research Specialist on-site.
