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Clinical Research Associate Manager-cancer Center
4 months ago
**Clinical Research Associate Manager-Cancer Center Protocol Office**
- (3291762)
**GENERAL SUMMARY/ OVERVIEW STATEMENT**:
**PRINCIPAL DUTIES AND RESPONSIBILITIES**:
- Clinical Trial Portfolio Management (~40%):_
- Serves as a central research resource for all clinical investigators:
- Advises and/or assists clinical investigators with initiating and developing clinical trial concepts, including protocol design and protocol writing.
- Assists in maintenance and organization of active protocol list.
- Advises and/or assists on completing relevant paperwork (along with departmental grants administrators) to facilitate transfer of data and/or specimens for research purposes (Data Use Agreements and Material Transfer Agreements).
- Assists investigators in grant writing preparation. Reviews and edits materials for grant submission or publication and/or presentation as needed.
- Maintains a good working knowledge of applicable institutional guidelines for proper research conduct, Code of Federal Regulations, International Code of Harmonization Guidelines, and State regulations.
- Collaborates with the CCPO to ensure timely submission and processing of clinical trial protocols, and timely response to IRB/SRC queries by the investigative team.
- Translational research infrastructure and program management (~40%):_
- Oversees and manages the translational research program and supporting infrastructure in the GI Cancer Center, including the tissue and blood bank, tumor biopsy platform, liquid biopsy platform, and immune-oncology platforms.
- Responsible for maintaining tissue and blood collection research protocols and ensuring protocols are carried out in accordance with IRB guidelines, including IRB paperwork and submissions.
- Oversees CRCs and RAs in the GI Cancer Center to ensure proper functioning of the translational research enterprise, including proper patient consent, specimen collection, data tracking, data analysis, and manuscript/presentation preparation.
- Works with PIs and Program Director to design and maintain Standard Operating Procedures to be followed CRCs for project-specific specimen collection and processing.
- Collaborates with grant management team, CCPO, Biostatistics and other departments and effectively manages project team to meet all deliverables and timelines for given
- Plans and leads agendas for regular related department research and project meetings and related deliverables.
- Collaborate with key research laboratory personnel in the Center for Cancer Research to streamline specimen delivery for analysis and assist with data management and analysis of experimental data.
- General Department Research Program Oversight (~20%):_
- Organized agenda for the biweekly GI oncology team meetings, including presenters/speakers, clinical trial enrollment data, clinical trial portfolio status. Works with disease center administrators to ensure meeting is well-organized and runs smoothly. Keeping list of action items to ensure follow up.
- Tracks and records key research metrics, such as clinical trial enrollment, translational protocol enrollment and specimen collection
- Enhances existing, or develops and implements, communication structures to raise awareness about research initiatives in the department (website management, Faculty Meeting presentations, newsletter articles, bi-annual departmental research survey, etc).
- Provides direct administrative supervision for research assistant, department database managers and clinical research assistants and coordinators, working jointly with PIs to set work expectations.
- Working collaboratively with Administrative Manager, indirect oversight of grant administration team.
- Works with the Program Director and other key faculty to promote Development efforts throughout the disease center.
- Develops and maintains database of all MGH GI oncology clinical research publications and grants, including collaborative publications
- Manages special projects as assigned by the Program Director
**SKILLS/ ABILITIES/ COMPETENCIES REQUIRED**:
- Ability to manage multiple assignments, projects, set priorities, work independently and meet appropriate time-frames
- Ability to see projects through from conception to completion.
- Ability to maintain confidentiality.
- Able to effectively manage research assistance to ensure effective functioning of the research team.
- Strong analytic skills and computer skills with MS office (Word, Excel, PowerPoint)
- Ability to work and interact effectively and positively with other staff members.
- Ability to exercise good judgment in appraising situations and making decisions.
**EDUCATION**:
- BA/BS degree required
**EXPERIENCE**:
- Minimum 3 years of directly related experience required
- A scientific background and familiarity with IRB-approved research procedures, clinical trials and molecular targets relevant to GI oncology, and key technologies (genomic analysis, liquid biopsy, etc) is strongly preferred.
- P
