Clinical Research Coordintor - OUD Genomics

Site: The General Hospital Corporation

 

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 Brain Bioethics Lab in the Department of Neurosurgery is seeking a full-time Clinical Research Coordinator (CRC) to join our team. The CRC- will assist with regulatory and operational needs for an NIH-funded study examining the ethical, clinical and legal challenges associated with the use of genetic tests for substance use disorders in clinical care. The CRC will work alongside team members to ensure high-quality study execution and compliance. The CRC will contribute to project execution, including employing qualitative and survey methods to collect and analyze data, and assist with manuscript preparation. This position is ideal for candidates with prior research experience who are looking to work in build upon existing research experience.

 

Job Summary

Summary
Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; and maintaining and updating data generated by the study. Candidates who are in the process of completing their bachelor's degree have a six-month grace period from their hire date (up to one year if starting on a per diem basis) to provide degree equivalency verification.

Does this position require Patient Care?
No

Essential Functions
-Reviews proposals for compliance with sponsor and organizational guidelines; verifies that all sponsor requirements are met.

-Recruiting patients for clinical trials and conducting phone interviews.

-Verifies the accuracy of study forms and updates them per protocol.

-Prepares data for analysis and data entry.

-Documents patient visits and procedures.

-Assists with regulatory binders and QA/QC Procedures.

-Assists with interviewing study subjects.

-Assists with study regulator submissions.

 

Qualifications

Education
Bachelor's Degree Related Field of Study required

Can this role accept experience in lieu of a degree?
Yes

Licenses and Credentials

Experience
Some relevant research project work 0-1 year preferred

Knowledge, Skills and Abilities
- Careful attention to detail and good organizational skills.
- Ability to follow directions.
- Good interpersonal and communication skills.
- Computer literacy.
- Working knowledge of clinical research protocols.
- Ability to demonstrate respect and professionalism for subjects' rights and individual needs.

 

Additional Job Details (if applicable)

Key Responsibilities

Study Coordination and Execution

• Assist with day-to-day study activities, including study recruitment, coordination and scheduling of study interviews, and coordination of team meetings.
• Assist with data collection (semi-structured interviews, surveys, chart reviews) and quality control checks, using REDCap, EPIC, and other programs.
• Assist with data analysis (qualitative interview data and quantitative survey data) using Dedoose, Excel, R, and other programs.
• Assist with preparation of manuscripts and presentations to disseminate study findings, as needed.

Regulatory and Compliance

• Assist with preparation of Institutional Review Board (IRB) protocol submissions, amendments, and continuing reviews.

Maintain compliance with study protocols, Human Subjects and Good Clinical Practice guidelines, and institutional policies.

Education & Experience

• Bachelor’s degree required (genomics, health sciences, social sciences, psychology, public health, neuroscience, or related field preferred)
• 2 years of post-baccalaureate research experience in human subjects research including direct experience with IRB/regulatory documentation.
• Experience with recruiting participants in clinical settings
• Experienc