Über diese Clinical Research Associate II Stelle bei Mass General Brigham
Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.
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.
The Multicenter 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
-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
Additional Job Details (if applicable)
Remote Type
Work Location
Scheduled Weekly Hours
Employee Type
Work Shift
Pay Range
$24.28 - $39.43/Hourly
Grade
6
EEO Statement:
Mass General Brigham Competency Framework
At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
