Senior Clinical Research Coordinator - OUD Genomics

Mass General Brigham•Somerville, MA

7d•$24 - $39•Onsite

About The Position

The Brain Bioethics Lab in the Department of Neurosurgery is seeking a full-time Senior Clinical Research Coordinator (CRC-Senior) to join our team. The CRC-Senior will oversee 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-Senior will help develop and implement the study’s standard operating procedures, assist with onboarding and training of junior clinical research coordinators (CRCs), and ensure high-quality study execution and compliance. The CRC-Senior will also 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 ready to take on higher-level, independent, program development responsibilities. Job Profile 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.; maintaining and updating data generated by the study. Additionally, it provides input into determining study subject suitability and input into recruitment strategy. Performs data analysis, interpretation, QA/QC, and assists in completing reports and presentations.

Requirements

Bachelor's Degree Science required
Related post-bachelor's degree research experience 1-2 years required
Ability to work more independently and as a team member.
Computer literacy, analytical skills, and ability to resolve technical problems.
Ability to interpret the acceptability of data results.
Working knowledge of data management programs.

Nice To Haves

Bachelor’s degree required (genetics, health sciences, social sciences, psychology, public health, neuroscience, or related field preferred); Master’s degree in one of the above areas is preferred.
Minimum of 3–5 years of post-baccalaureate research experience in human subjects research including direct experience with IRB/regulatory documentation.
Experience with building recruitment and data collection pipelines to execute both qualitative and quantitative data collection
Experience analyzing and reporting findings from mixed-methods studies
Ability to oversee and train others effectively.
Strong organizational, time management, and problem-solving skills.
Demonstrate a high degree of flexibility in accepting work assignments with the ability to effectively prioritize tasks, understand processes, and resolve issues
Excellent interpersonal and written/verbal communication skills.
Ability to work independently and collaboratively across multiple investigators and teams.

Responsibilities

Assists with determining the suitability of study subjects and acts as a resource for patients and families.
Has input into recruitment strategies and may contribute to protocol recommendations.
Administers scores and evaluates study questionnaires.
Maintains research data, patient files, regulatory binders, and study databases.
Performs data analysis and QA/QC checks and organizes and interprets data.
Assists with preparation for annual review and assists PI in completing study reports and presentations.
May assist with training and orientation of new staff members.
Oversee study operations and assist with coordinating all study activities between the Brain Bioethics lab and external collaborators.
Assist with development of standard operating procedures and quality assurance systems for study
Contribute to creation of study templates, database management, and training materials for new study staff
Train and mentor entry-level CRCs and study interns, ensuring adherence to the lab’s standard operating procedures and best practices.
Work with study PIs to manage day-to-day study activities, including study recruitment, coordination and scheduling of study interviews, and coordination of team meetings.
Develop and maintain project timelines, recruitment benchmarks, and operational workflows.
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.
Prepare and maintain Institutional Review Board (IRB) protocol submissions, amendments, and continuing reviews.
Ensure compliance with study protocols, Human Subjects and Good Clinical Practice guidelines, and institutional policies.
Prepare progress reports for key stakeholders and funders.