Description
The Cancer Center Protocol Office is seeking a motivated, detail-oriented individual to join our team as a Clinical Research Project Manager for Quality Assurance. The Cancer Center Protocol Office (CCPO) is a centralized clinical research office that support clinical researchers in all disciplines within the MGH Cancer Center. Our office promotes and facilitates clinical research by providing comprehensive trial implementation and regulatory affairs services.
The Clinical Research Project Manager will independently lead multiple quality assurance initiatives including performance-based chart reviews, clinical trial monitoring, data compliance oversight and audit preparation for National Cancer Institute (NCI) sponsored cooperative group trials and identification and establishment of research operations best practices
Principal Responsibilities
- Regulatory review of patient charts to assess for accuracy, completeness, and adherence to institutional standard operating procedures, GCP and Code of Federal Regulations (CFR).
- Confirmation of proper consent process and documentation.
- Source documentation verification and regulatory documentation review.
- Drug accountability and DARF reconciliation.
- Evaluation and verification of protocol procedures, regulatory and data compliance and alignment with federal and local regulations.
- Identify variance across teams' operation and documentation practices; establish and consult on best practices.
- Coordination data compliance efforts for all NCI Cooperative Group Trials.
- Coordinate NCI Cooperative Group compliance audits across impacted teams, including audit preparation and coordination response to identified audit deficiencies to ensure consistency.
- Provide audit prep and outcome support/guidance for external audits.
- Assist and consult with CCPO Leadership on global program initiatives, including development and expansion of quality assurance techniques, systematic safeguards and process improvement measures.
- Staying current with federal and local regulations, guidance and quality assurance trends as they pertain to the conduct of clinical research.
Qualifications
- BA/BS degree required, Master’s preferred.
- 5 years related clinical research experience required.
- Prior supervisory experience preferred.
Skills Required
- Exceptional time management skills with the capacity to prioritize among multiple tasks and change direction in response to fluctuating demands.
- Excellent written and verbal communication skills.
- Ability to distill and clarify complex issues to a variety of collaborators.
- Able to work successfully in a hybrid environment while demonstrating and fostering initiative and accountability.
- Motivated to help team achieve results and meet deadlines.
- Able to communicate with diverse teams with different skill sets, work styles and professional roles.
- Problem-solving skills, including the ability to gather information, identify resources, and develop alternatives.
- Identifies key priorities and helps manage change and ambiguity.
- Keen ability to anticipate and address potential issues proactively.
- Knowledge of current and developing clinical research trends.
- Familiarity with the Code of Federal Regulation (CFR) and Good Clinical Practice (ICH GCP).
Working Environment
- Duties will be performed in a hybrid setting; recurring in-office presence anticipated. Applicants should reside in the greater Boston area.
- Position focuses on clinical trial operations and does not include patient contact.