Note: The job is a remote job and is open to candidates in USA. Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. The Assistant Clinical Research Manager position will assist in managing the Breast Oncology clinical research program, ensuring compliance with regulatory standards and overseeing clinical trial operations.

Responsibilities

• 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
• 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
• 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
• 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

Skills

• Bachelor's Degree required
• 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
• 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
• Must have the ability to function independently, think critically and with good professional judgment
• Minimum of 3 plus years of related experience preferred

Benefits

• Remote: 100% off site

Company Overview

Company H1B Sponsorship