Location: Cleveland, OH
Responsibilities:
- Coordinates and monitors studies to ensure compliance with protocols, regulatory requirements, and Good Clinical Practices.
- Develops study protocols, informed consent forms, case report forms, databases, and other study support documentation for studies sponsored by SPR Therapeutics.
- Drives site selection and subject recruitment programs that deliver enrollment targets.
- Prepares/reviews monitoring reports following study site visits.
- Provides formal oversight of sponsor obligations transferred to CRO’s and other providers.
- Assists sites in preparing IRB submissions and annual reports.
- Develops internal standard operating procedures for the conduct of clinical studies.
- Develops and implements data management methodologies for the conduct of clinical studies.
- Trains clinical site staff on study protocols and data management methods.
- Negotiates sites budgets and contracts.
- Monitors and manages the clinical trial budget according to research contracts. Reviews and approve invoices from sites and providers to ensure accurate, and timely payment.
- Works directly on client consultant projects, generating billable services.
- Plans and conducts Investigator Meetings in conjunction with the Clinical Team.
- Prepares regulatory submissions for SPR products and clinical studies, including IDE’s, 510(k)’s, PMA’s, HDE’s, and Annual Reports, as needed.
- Supervises assigned Clinical team members.
Requirements:
- BS degree or higher in Life Sciences or related technical or clinical field.
- Minimum of 4 years clinical research experience with the design, management and conduct of medical device or drug related clinical studies.
- Familiarity with neurostimulation or neuromodulation medical devices a plus.
- Knowledge of FDA guidelines and Good Clinical Practices.
- Ability to travel (moderate) depending on the clinical studies.
Why Join Our Team?
- Excellent career opportunity in the medical device industry
- Ability to work with game changing technology
- Competitive compensation and benefits
- Employee Wellness Program