Clinical Research Associate Manager---Cancer Center Protocol Office

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The MGH Cancer Center is seeking a Clinical Research Associate Manager to join their team. The candidate will report directly to the Director of the Gastrointestinal Cancer Center Program and will be responsible for managing a portfolio of projects, including clinical research projects and collaborative research projects integrating laboratory and clinical efforts. The candidate will be responsible for the effective organization and coordination of these projects, including meeting coordination, managing action items, and follow up. The candidate will also be responsible for the overall planning, development, establishment and administration of the operational and administrative systems supporting the GI Cancer Center's research program overall, with focus on clinical and translational research. The candidate will be responsible for facilitating the effective execution of the disease center's research activities, managing tasks required for project completion, as well as preparation and submission of reports, agreements, contracts, and presentations. The candidate will also manage a team of clinical research coordinators/research assistants to ensure efficient functioning of the clinical and translational research infrastructure.

The candidate must have excellent communication skills and the ability to multi-task. The person must provide effective management in all areas of administration, project completion, information technology and development. He or she must be able to work closely and effectively with a group of staff members.

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.

• Monitors and ensures compliance of all clinical researchers and their research teams with NIH and MGH required human subjects protection training.

• 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:

• Candidate must be highly organized, detail-oriented, and motivated

• 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.

• Prior experience within the Cancer Center Protocol Office (CCPO) preferred

SUPERVISORY RESPONSIBILITY:

• Manages 4 FTEs, including CRCs in the GI Center and additional support staff as needed, to ensure proper functioning of the clinical and translational research program

• Ensures appropriate coverage with the group during personnel absences