Job Description - Clinical Research Project Manager, Dermatology (3308763) The Project Manager will serve as the operational lead for the Cutaneous Squamous Cell Cancer Registry, and related NIH and industry funded cohort studies. The PM works under the direction of the Registry's PI, and is located at BWH Faulkner. The PM develops, executes, and oversees work on research study protocols funded by the NIH and/or pharmaceutical companies, and is responsible for the day to day operations of these studies
- Oversees the day-to-day operations of the CSCC repository and its ongoing projects in accordance with the protocols, including:
- management of prospectively collected data and tissue samples and
- management of obtaining blocks and slides from existing tissue banks
- Manages a multi-site collaboration which includes foreign sites. Candidate should be knowledgeable of NIH/HIPAA/GDPR regulations, including foreign components and data issues that arise from foreign collaborators.
- Ensures adherence to all relevant good clinical practice and privacy regulations.
- Develops policies and procedures across the registry sites and for cohort studies.
- Formulate strategies for research participant recruitment and retention. Assists with subject recruitment for prospective study and data mining to identify subjects for retrospective studies.
- Manages a large RedCap database housing all information for the registry.
- Collects and reviews study data, ensuring compliance with protocol and data integrity. Develops best practices for others involved in data collection and data entry. Drafts corrective action plans for any issues identified through quality control mechanisms.
- Will be responsible for all programmatic and financial coordination
- Monitors sample acquisition to ensure project milestones are continuously met and initiate mitigation plans if needed with participating sites.
- Oversees regulatory aspects of the repository and cohort studies, including monitoring or coordinating a monitoring body, safety and protocol violation documentation as appropriate. Ensures audit-ready files are kept.
- Coordinates any requests for data and tissue from the repository with the tissue use committee.
- Develops and maintains productive partnerships with internal and external stakeholders including communication plans and setting of program milestones.This position will be located primarily at Faulkner Hospital.At least five years of progressively more responsible research experience.Project Management Professional (PMP) certification preferred, but not required. Bachelors required, Masters degree preferred.At least five years of progressively more responsible research experience.Project Management Professional (PMP) certification preferred, but not required. BWH is an Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. - We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Primary Location Primary Location MA-Boston-BWFH Brigham and Women's Faulkner Hospital Other Locations Work Locations BWFH Brigham and Women's Faulkner Hospital #J-18808-Ljbffr