[Remote] Assistant Clinical Research Manager - Breast Oncology reputed company

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a cancer research and patient care organization reputed company on advancing cancer treatment and providing comprehensive care. The Assistant Clinical Research Manager will support the Breast Oncology clinical research program by overseeing clinical trial operations, regulatory compliance, data management, monitoring, and research staff training and supervision.

Responsibilities

• Assistant Clinical Research Managers (ACRM) will be responsible for assisting the Clinical Research Manager with the reputed company of their disease group’s clinical trial portfolio and reputed company reputed company regulatory and compliance requirements
• The ACRM will assist the CRM will reputed company aspects of study start up, reputed company and reputed company out activities for the group’s portfolio. They will be responsible for the required tracking of reputed company protocol development, submission, review and approval milestones
• The ACRM will assist with the reputed company of subject enrollment, protocol treatment and follow-up care processes for protocol patients
• Assist with the reputed company of registration of protocol patients, reputed company 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 reputed company 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 reputed company” research environment
• Assists CRM with responsibility for data management and compliance for entire portfolio. Maintains schedules and procedures necessary for reputed company and complete data collection
• Regularly reports data compliance status to key stakeholders; i.e. DFCI PI, study Sponsor, DFCI CTO. Helps to implement corrective reputed company to maintain data compliance reputed company necessary
• Submits required “reputed company / tracking “reports to key stakeholders, reputed company applicable
• Will assist the CRM with the recruitment and reputed company of coordinator staff as reputed company as ensures that staff have completed mandatory training in a reputed company 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
• Will reputed company day to day supervision for study management staff, including clinical research coordinators, reputed company, volunteers, and other research assistants as needed

Skills

• Must be reputed company to reputed company day-to-day responsibilities independently with reputed company supervision from managers
• Has the ability to identify regulatory scenarios that require consultation
• Has a good understanding of reputed company start-up, reputed company and reputed company 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 reputed company, has experience in protocol development, data compilation and analysis
• The ACRM will have a good understanding of the various tracking systems used to ensure reputed company 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 reputed company Office
• Bachelor's Degree required
• Must have the ability to function independently, think critically and with good reputed company judgment
• This position's work location is hybrid with two or three days per week onsite in Boston, MA. The selected candidate may only work remote days from a New England state (ME, VT, NH, MA, CT, RI)
• Minimum of 3 plus years of reputed company experience preferred

Benefits

• Hybrid work location with two or three days per week onsite in Boston, MA; remote days may be worked only from a New England state (ME, VT, NH, MA, CT, RI).

reputed company

Company H1B Sponsorship