Assistant Clinical Research Manager - Head & Neck Oncology

Dana-Farber Cancer Institute•Boston, MA

1d•$70,000 - $85,300

About The Position

The Assistant Clinical Research Manager (ACRM) position will work within the Head & Neck Oncology clinical research program and assist in the management of the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. These positions, in collaboration with the program’s Clinical research Managers physicians and research nursing staff, are 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. This position is designed to be a transition role. It is intended for new managers with no prior supervisory experience. 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.

Requirements

Must be able to perform day-to-day responsibilities independently with minimal supervision from managers.
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.
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 understand 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.
Bachelor’s Degree required
Minimum of 3 plus years of related experience preferred.
Must have the ability to function independently, think critically and with good professional judgment.

Responsibilities

Assist in the management of the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator.
Assist with the design, implementation and evaluation of their program’s clinical research activities, related regulatory oversight
Provide day to day supervision of their program’s clinical research staff as needed.
Assist the Clinical Research Manager with the oversight of their disease group’s clinical trial portfolio and all related regulatory and compliance requirements.
Assist the CRM will all aspects of study start up, active and close out activities for the group’s portfolio.
Responsible for the required tracking of all protocol development, submission, review and approval milestones.
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.
Assist in the responsibility for essential document compliance for entire portfolio.
Implements systems to monitor and ensure regulatory document collection and maintenance compliance.
Assist in the responsibilities for all clinical trial reporting requirements; safety event, annual approval, deviations etc.
May implement systems to monitor portfolio compliance.
Assist the study team to be maintain an “audit ready” research environment
Assist 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.
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.
Help implement program specific on-boarding and orientation process and may participate in annual performance evaluations and competency assessments of research staff as needed.