What are the responsibilities and job description for the Protocol Project Manager, Hematopoietic Malignancies Program position at University of California San Francisco?
The Protocol Project Manager (PPM) will work in the Hematopoietic Malignancies research program and serve as the main point of contact between the study team including faculty and clinical research coordinators (CRC), outside entities such as sponsors, and the Clinical Research Support Office (CRSO), which is a centralized service unit in the HDFCCC offering clinical trial management services. The candidate will be accountable for clinical trial study start up, maintenance and close out, and may assist with study operations, including participant management and data entry, as required.
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A successful applicant will thrive in a fast-paced environment, take initiative, and resolve problems and provide clarity in ambiguous situations. We are looking for a go-getter with excellent relationship building skills, and a team player who can also work independently.
Duties Include :
- Complete pre-activation tasks such as feasibility surveys and assessment with study team.
- Coordinate protocol reviews and submissions to Disease Site Committee and Protocol Review and Monitoring Committee.
- Identify ancillary committee approval with study team required by a protocol and initiate the process for review.
- Assist PI with the development of concept sheets, investigational brochure or package insert for CRSO regulatory protocol editor for investigator-initiated trials.
- Ensure timely processing of new protocols through the activation pipeline including Medicare coverage analysis and budget sign off, informed consent approval and IRB submission, contract execution, and billing set up.
- Ensure policies mandated by the HDFCCC, federal government, any outside entity and study team are followed during trial activation pipeline, maintenance phase and close-out.
- Coordinate and prepare for sponsor or collaborator visits such as site initiation, audit and monitor visits.
- Update clinical trial management databases.
- Study coordination and data collection for multiple studies within the program's portfolio.
- Assist study team to develop contingency action plans.
- Flexibility to adapt to changing circumstances.
- Excellent organizational skills, multitasking and communication both written and spoken.
This is a fully remote position.
Note : This position will require a physical / health screening.
The final salary and offer components are subject to additional approvals based on UC policy.
Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.
The salary range for this position is $41.72 - $67.10 (Hourly Rate).
To learn more about the benefits of working at UCSF, including total compensation, please visit : https : / / ucnet.universityofcalifornia.edu / compensation-and-benefits / index.html
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Salary : $42 - $67
