Clinical Research Associate II---Cancer Center Protocol Office

General Summary/ Overview Statement

The Program for the Coordination and Oversight of Research Protocols (PCORP) within the MGH Cancer Center Protocol Office specializes in the central coordination, monitoring and regulatory oversight of Investigator-initiated, multi-center clinical trials. PCORP is seeking Clinical Research Associate (CRA) candidates to assist with the coordination and monitoring of multiple oncology trials.

The multi-center CRA works under general supervision to maintain regulatory files and monitor data quality and data and protocol compliance across participating study sites. The CRA will be trained on the institutional and federal regulations governing clinical research. The position involves a high volume of regulatory document coordination and tracking and clinical data review. This position does not include any direct patient contact.

Principal Duties And Responsibilities

The CRA will perform the following duties under general supervision by the Clinical Research Manager:

Track the progress of the trial across all participating sites (e.g., accrual, biospecimen collection and transfer, reportable events, regulatory submissions)

Correspond with participating sites to support trial activities as needed:

Answer questions about eligibility, study procedures or data entry

Prepare and distribute informational updates, including meeting minutes, missing data reports and safety reports

Communicate essential trial information and documentation, including protocol amendments; request routine updates from sites to maintain current study status

Facilitate database reviews and query resolution

Present the Sponsor-Investigator study status reports related to trial progress and assigned tasks

Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria

Conduct onsite and remote monitoring visits and complete corresponding monitoring reports (Domestic travel required for onsite monitoring

• Perform source document verification and drug accountability
• Review study site regulatory binder and essential documents for completeness and accuracy
• Evaluate ongoing protocol and data compliance
• Issue, track and resolve queries

Gather, track and organize essential regulatory documents from participating sites

Facilitate and document Sponsor-Investigator review of safety reports, investigational drug brochure updates, study violations and adverse events

Submits routine and expedited reports to the FDA, IRB, funding sponsor or other stakeholders.

Skills/ Abilities/ Competencies Required

• Careful attention to details
• Superior organizational and time management skills and ability to prioritize multiple tasks
• Problem-solving skills, including the ability to gather information, identify resources, and develop alternatives
• Excellent written and oral communication skills
• Able to work successfully in a fully remote environment
• Demonstrate initiative and accountability
• Ability and willingness to travel nationally.
  
  

The Clinical Research Associate II Should Also Possess

• Working knowledge of clinical research protocols
• Ability to work independently with general supervision
• Analytical skills and ability to identify and resolve problems and develop alternatives
• Excellent judgment and ability to interpret information and protocol requirements
  
  

Education

• Bachelor’s degree required
  
  

Experience

• Minimum of 1-2 years of directly related work experience
  
  

Supervisory Responsibility

• A Clinical Research Associate II may assist with the training and orientation of new staff members
  
  

Fiscal Responsibility

• CRAs are responsible for conducting onsite monitoring visits in adherence to institutional travel policy and submitting expense documentation in a timely fashion.
  
  

Working Conditions

• Duties will mainly be performed in a remote setting; limited in-office presence anticipated. Applicants may work in all states with the following exceptions: WY, ND, Puerto Rico, and the U.S. Virgin Islands.
• Less than 25% domestic travel (1-2 field visits per month maximum)
• Does not include patient contact
  
  

Primary Location

MA-Boston-MGH Main Campus

Work Locations

MGH Main Campus

Job

Research-Management

Organization

Massachusetts General Hospital(MGH)

Schedule

Full-time

Standard Hours

40

Shift

Day Job

Employee Status

Regular

Recruiting Department

MGH Cancer Ctr - Protocol

Job Posting

Sep 13, 2024