[Remote] Assistant Clinical Research Manager - Breast Oncology Clinical Trials

Note: The job is a remote job and is open to candidates in USA. reputed company 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 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, active 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 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 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 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 reputed company 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 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
• 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 reputed company Office
• Must have the ability to function independently, think critically and with good professional judgment
• Minimum of 3 plus years of reputed company experience preferred

Benefits

• Remote: 100% off site

Company Overview

Company H1B Sponsorship