Assistant Clinical Research Manager - Pediatric Oncology Solid Tumor program

A full time Assistant Clinical Research Manager (ACRM) position is available in the pediatric Solid Tumor Program at Dana-Farber Cancer Institute. The pediatric Solid Tumor Program is one of the largest in the world and treats children with a range of solid tumor diagnoses, providing novel and cutting edge therapies for these rare diseases. Most of the patients we care for choose to participate in tissue banking studies and correlative biology trials. The hired ACRM will work within the Solid Tumor Biology group, and will assist with day to day operations of a team of clinical research coordinators (CRCs) who perform consenting, collect samples, and distribute tissue for banking and laboratory research. The ACRM and CRCs interact directly with the principal investigators (research faculty) of each of the banking and biology studies within our program. Furthermore, this position is a unique opportunity to work directly with research scientists, pathologists, the biobanking cores, institutional review board (IRB), and patients. The ACRM will also assist investigators to write new studies, guide those studies through IRB approval, conduct continuing reviews and amendments, and assure that studies are being conducted according to Dana-Farber’s high standards for patient research practices. The ACRM, in collaboration with the program’s Clinical Research Manager will be responsible for assisting with the design, implementation and evaluation of their program’s clinical research activities, related regulatory oversight, and will provide day to day supervision of their program’s clinical research staff as needed. The position resides within a division-wide Center for Clinical and Translational Research which is led by a senior research team that previously rose through the ranks of our research program and by world-leaders in clinical and biologic research in pediatric oncology. The experiences and responsibilities of this ACRM role are expected to lead to numerous opportunities to learn and for advancement within the division and the institution.

Only applicants living within New England (ME, VT, NH, MA, CT, RI) at the time of employment will be considered. Candidates must have the ability to work from our Boston, MA office for onsite days.

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

Clinical Trials Operations

• Assistant Clinical Research Managers (ACRM) will be responsible for assisting the Clinical Research Manager with the oversight of their disease group’s clinical trial portfolio and all related regulatory and compliance requirements.

• The ACRM will assist the CRM will all aspects of study start up, active and close out activities for the group’s portfolio. They will be responsible for the required tracking of all protocol development, submission, review and approval milestones.

• The ACRM will assist with the oversight of subject enrollment, protocol treatment and follow-up care processes for protocol patients.

• Assist with the oversight of registration of protocol patients, study group registrar and pharmaceutical company as outlined in protocol.

Regulatory & Compliance

• Assists in the responsibility for essential document compliance for entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance compliance.

• Assists in the responsibilities for all clinical trial reporting requirements; safety event, annual approval, deviations etc. May implement systems to monitor portfolio compliance.

• Assists the study team to be maintain an “audit ready” research environment

Data Management & Clinical Trial Monitoring

• Assists CRM with responsibility for data management and compliance for entire portfolio. Maintains schedules and procedures necessary for timely and complete data collection.

• Regularly reports data compliance status to key stakeholders; i.e. DFCI PI, study Sponsor, DFCI CTO. Helps to implement corrective action to maintain data compliance when necessary.

• Submits required “progress / tracking “reports to key stakeholders, when applicable.

Staff Training & Development

• Will assist the CRM with the recruitment and oversight of coordinator staff as well as ensures that staff have completed mandatory training in a timely manner. Will help implement program specific on-boarding and orientation process and may participate in annual performance evaluations and competency assessments of research staff as needed.

• SUPERVISORY RESPONSIBILITIES: (no direct reports)

  Will provide day to day supervision for study management staff, including clinical research coordinators, students, volunteers, and other research assistants as needed.

• COMPETENCIES:

  • Must be able to perform day to day responsibilities independently with minimal supervision from manager.
  • Has the ability to identify regulatory scenarios that require consultation.
  • Has a good understanding of clinical trials start-up, active and close out phases.
  • Has a good understanding of clinical research local policy and federal regulation.

  MINIMUM JOB QUALIFICATIONS:

  Bachelor’s Degree required, with a minimum of 3 plus years of related experience preferred. Must have the ability to function independently, think critically and with good professional judgment.

  KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

  Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process. In addition has experience in protocol development, data compilation and analysis. The ACRM will have a good understanding of the various tracking systems used to ensure timely data management by the clinical research staff. They will also have an understanding of Federal and State regulations as they relate to research. Strong interpersonal, organizational and communication skills are required. Must have computer skills including the use of Microsoft Office.

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.

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