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Clinical Research Assistant - Women's Mental Health

Mass General Brigham
United StatesRemotefull_timeVerifiedPosted 28 Jun 2025

About the role

Site: The McLean 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.


 

We are looking for a CRA to support a two-year FDA-regulated clinical trial examining MDMA-assisted therapy for posttraumatic stress disorder. Tasks would involve: performing administrative duties as required; coordinating and scheduling study activities; chaperoning participants to visits; creating standard operating procedures; preparing, submitting, and revising IRB and regulatory applications to the DEA and FDA; data collection and entry; maintenance of study records in compliance with good clinical practice; statistical analyses of data; assisting with formal audits; documenting participant visits; providing a basic explanation of the study to interested participants; administration, scoring, and interpreting questionnaires and psychodiagnostic assessments under supervision of the PI; assisting PI to prepare study reports, presentations, and manuscripts.

Attention to detail, a high level of organizational skills, strong interpersonal skills are necessary. Previous exposure to psychodiagnostic assessment (e.g., has previously shadowed a SCID, MINI), experience working on a clinical trial, familiarity with R programming, and experience accompanying participants to MRI scans is preferred but not required.


 

Job Summary

Summary<br>Working under the supervision of a Senior Research Assistant, Manager or Principal Investigator and following established policies and procedures, provides assistance on clinical research studies.

Supervisor available to handle unusual situations and regularly reviews progress of work.<br><br>Does this position require Patient Care?<br>No<br><br>Essential Functions<br>-Collects and organizes patient data. <br>
-Maintains records and databases. <br>
-Uses software programs to generate graphs and reports. <br>
-Recruiting patients for clinical trials, conducts phone interviews and schedules patients for visits. <br>
-Obtains patient study data from medical records, physicians, etc. <br>
-Conducts library searches. <br>
-Performs administrative support duties as required. <br>
-Verifies accuracy of study forms. <br>
-Updates study forms per protocol. <br>
-Prepares data for analysis and data entry. <br>
-Assists with formal audits of data. <br>
-Documents patient visits and procedures. <br>
-Assists with regulatory binders and QA/QC procedures. <br>
-Assists with interviewing study subjects. <br>
-Administers and scores questionnaires. <br>
-Provides basic explanation of study and in some cases obtains informed consent from subjects. <br>
-Performs study procedures such as phlebotomy. <br>
-Assists with study regulatory submissions. <br>
-Writes consent forms. <br>
-Verifies subject inclusion/exclusion criteria. <br>


 

Qualifications

Education
Bachelor's Degree required

Can this role accept experience in lieu of a degree?
No

Licenses and Credentials

Experience
Related experience 0-1 year

Knowledge, Skills and Abilities
- Careful attention to details.
- Good organizational skills.
- Ability to follow directions.
- Good interpersonal and communication skills.
- All employees must possess basic computer skills to use a variety of electronic or online systems for communication, clinical and administrative purposes.
- Working knowledge of clinical research protocols.
- Ability to demonstrate respect and professionalism for subjects' rights and individual needs.
- Works independently under close supervision.


 

Additional Job Details (if applicable)

Physical Requirements

  • Standing Frequently (34-66%)
  • Walking Frequently (34-66%)
  • Sitting Occasionally (3-33%)
  • Lifting Frequently (34-66%) 35lbs+ (w/assisted device)
  • Carrying Frequently (34-66%) 20lbs - 35lbs
  • Pushing Occasionally (3-33%)
  • Pulling Occasionally (3-33%)
  • Climbing Rarely (Less than 2%)
  • Balancing Frequently (34-66%)
  • Stooping Occasionally (3-33%)
  • Kneeling Occasionally (3-33%)
  • Crouching Occasionally (3-33%)

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Company

Mass General Brigham

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