Clinical Research Associate II

Job Summary

The Multicenter Program within the MGB Cancer Institute Clinical Trials Office is seeking candidates experienced in clinical trial coordination and implementation to support multicenter coordination and monitoring of investigator-initiated oncology clinical trials. The Multicenter Program is an internal clinical trial operations team, specializing in the central coordination, monitoring and regulatory oversight of MGBCI investigator-initiated clinical trials that are expanded to participating sites outside of the Harvard Cancer Consortium. The multicenter CRA works under general supervision to support trial coordination, maintain regulatory files and monitor data and protocol compliance and data quality across participating study sites. The CRA will be trained in the institutional and federal regulations governing clinical research. The position involves a high volume of correspondence, regulatory document coordination and tracking, and clinical data review. This position does not include any direct patient contact.

Responsibilities

• 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
• Submit routine and expedited reports to the FDA, IRB, funding sponsor or other stakeholders

Qualifications

Education: Bachelor's Degree required. Experience: Related research experience 1-2 years required.

Knowledge, Skills and Abilities

• Ability to work independently and as a team member.
• High degree of computer literacy.
• Ability to interpret the acceptability of data results.
• Ability to demonstrate respect and professionalism for subjects' rights and individual needs.
• Careful attention to detail
• 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
• Demonstrate initiative and accountability
• Ability and willingness to travel nationally.
• Working knowledge of clinical research protocols
• Analytical skills and ability to identify and resolve problems and develop alternatives
• Excellent judgment and ability to interpret information and protocol requirements