Clinical Research Coordinator
GENERAL SUMMARY/ OVERVIEW STATEMENT:
The Clinical and Research Program in Pediatric Psychopharmacology is seeking to hire a Clinical Research Coordinator (CRC) to aid in ongoing research studies for Dr. Timothy Wilens, including one or both of the following:
- Systematic data collection and procedural compliance for a longitudinal study of outpatient behavioral health patients (ages 16-30) at Massachusetts General Hospital as part of a National Institute of Health funded prevention grant (HEAL initiative, https://heal.nih.gov/research/new-strategies/at-risk-adolescents). This study aims to evaluate psychopathology, opioid use disorder (OUD), nicotine and other substance use disorders (SUDs) and to explore important mediators and moderators of the effect of treatment of psychopathology on the onset or exacerbation of OUD/SUD.
- An interventional trial testing the efficacy of a novel digital health technology in treating SUD in detox settings.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Collects & organizes patient data
- Maintains records and databases
- Uses software programs to generate graphs and reports
- Assists with recruiting patients for clinical trials
- Obtains patient study data from medical records, physicians, etc.
- Conducts library searches
- Verifies accuracy of study forms
- Updates study forms per protocol
- Documents patient visits and procedures
- Assists with regulatory binders and QA/QC procedures
- Assists with interviewing study subjects
- Administers and scores questionnaires
- Provides basic explanation of study and in some cases obtains informed consent from subjects
- Performs study procedures, which may include phlebotomy.
- Assists with study regulatory submissions
- Writes consent forms
- Verifies subject inclusion/exclusion criteria
- Performs administrative support duties as required
A Clinical Research Coordinator II performs the duties of a Clinical Research Coordinator I (above) and may also:
- Maintain research data, patient fields, regulatory binders and study databases
- Perform data analysis and QA/QC data checks
- Organize and interpret data
- Develop and implement recruitment strategies
- Act as a study resource for patient and family
- Monitor and evaluation lab and procedure data
- Evaluate study questionnaires
- Contribute to protocol recommendations
- Assist with preparation of annual review
- May assist PI to prepare complete study reports
SKILLS/ABILITIES/COMPETENCIES REQUIRED:
- Careful attention to details
- Good organizational skills
- Ability to follow directions
- Good communication skills
- Computer literacy
- Working knowledge of clinical research protocols
- Ability to demonstrate respect and professionalism for subjects’ rights and individual needs
The Clinical Research Coordinator II should also possess:
- Ability to work independently and as a team player
- Analytical skills and ability to resolve technical problems
- Ability to interpret acceptability of data results
- Working knowledge of data management program
EDUCATION:
Bachelor’s degree required.
EXPERIENCE:
New graduates with some relevant course/project work or those without any prior research experience will be considered for the Clinical Research Coordinator I position outlined above.
Those with a minimum of 1-2 years of directly related work experience will be considered for a Clinical Research Coordinator II position.
SUPERVISORY RESPONSIBILITY (if applicable):
A Clinical Research Coordinator I does not have any supervisory responsibility.
A Clinical Research Coordinator II may assist with the training and orientation of new staff members.