Research Clinic Manager
The primary duty for the Research Clinic Manager is to lead the day-to-day operations and manage the staff of an established clinical research and private practice dermatology group. To do this the Research Clinic Manager performs a variety of activities including, but not limited to:
- Exhibit behavior and communication skills that demonstrate a commitment to superior customer service, including quality care and concern, with every internal and external customer.
- Responsible for the management of the clinical research group and private practice clinic activities.
- Providing leadership and clinical supervision of staff members with respect to research and clinic activities, coordinating duties etc.
- Attend Investigator Meetings as required and participate in meetings/conferences related to study protocols and research.
- Evaluate protocols and budgets for new clinical study opportunities.
- Lead study start-up activities, SIVs (Site Initiation Visits), audits etc.
- Ensure compliance with applicable licensure/certification requirements, applicable healthcare standards and government laws and regulations, as well as policies and procedures.
- Maintain knowledge base as to developments and trends in clinical research study execution.
- Oversee updating and maintenance of the electronic patient database.
- Develop thorough understanding of the database functionality and serve as resource to other users
- Maintain training records for team members and manage updates to training modules in line with industry and regulatory guidance and requirements.
- Attend and lead weekly staff meetings and review protocol updates, training updates or other items as necessary
- Work with Contracts and Finance Contacts as well as Regulatory Associate to ensure all study start up materials are submitted in a timely manner to applicable sponsors and/or regulatory agencies
- Meet/speak with the Sponsor representatives and serve as point of contact to discuss study logistics, start-up activities, budgets, etc.
- Supervise and Manage Compliance and training programs such as OSHA, HIPAA, other in house trainings, etc.
- Have a working knowledge of all sponsors’ protocols
- Serve as back up or study support staff to study coordinators and front desk staff when needed.
- Bachelor's Degree (Science or Medical-related).
- At least five years clinical research experience with a strong understanding of GCP, ICH guidelines.
- Minimum three years management experience.
- Advanced Degree a plus.