Job SummarySummary:
Responsible for managing a clinical study involving multiple sites around the world. Leading the efforts on selecting the sites, testing the sites capabilities to ensure long-term compliance, engaging in contractual agreements with the sites, working together with the department to manage the execution of the site agreements, training the staff at each site with respect to the study protocol and data upload to the web-based data collection system. Responsible for the generation of standard operating procedures; works directly with investigators, clinicians, software developers and other lab personnel.
Essential Functions:
- Engages potential sites and tests their capabilities for long-term compliance.
-Trains the site coordinators at each clinical site.
-Monitors the site coordinators at each clinical site.
-Trains newly hired technical staff to work on this project.
-Responsible for the generation and maintenance of standard operating procedures.
-Responsible for communicating project progress with the sponsor.
-Responsible for troubleshooting problems related to access the web based registry.
-Prepares reports and presents progress at research staff meetings.
-Coordinates the submission of federal (NIH, DPH) and non-federal (private foundations) grant proposals, subaward proposals, JIT, and progress reports.
-Develop budgets and supporting documentation for grant applications.
-Prepares and submits grant applications in NIH ASSIST, PCORI Online, and other sponsor portals.
-Assist in identifying new funding opportunities to support the Center's research mission.
-Prepares agreement modifications (effort changes, carry forward requests, no-cost extensions, other prior approvals).
-Prepares, submits, and manages agreements (DUAs, MTAs, CDAs, Institutional Service Agreements, Billing Agreements) through Insight.
-Supervises operations of all study staff.
-Acts as point of contact to provide direction and guidance to program staff regarding day-to-day issues and activities.
QualificationsEducation
Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree?
No
Licenses and Credentials
Experience
Research Related Experience 3-5 years required
Knowledge, Skills and Abilities
- Excellent critical thinking skills and ability to work independently are essential.
- Must be self-motivated and able to work independently.
- Good verbal and written communication skills.
- Proficiency in Word, Power point, Excel.
- Ability to make independent effective decisions.
- Strong organizational skills.
- Demonstrated analytical skills to problem solve effectively.
- Familiarity with grant submissions processes and various grant award mechanism
- Strong computer proficiency and database managemrnt
- Maintains standard of excellence regarding program functioning and compliance, honoring institutional and federal policies (i.e. regulatory requirements)
- program functioning and compliance, honoring institutional and federal policies (i.e., regulatory requirements, quality improvement/assurance)
Additional Job Details (if applicable)Remote TypeRemote
Work Location101 Merrimac Street
Scheduled Weekly Hours40
Employee TypeRegular
Work ShiftDay (United States of America)
Pay Range$78,936.00 - $128,928.80/Annual
Grade8
