Clinical Research Coordinator

GENERAL SUMMARY/ OVERVIEW STATEMENT: Summarize the nature and level of work performed.

The Massachusetts General Hospital Dauten Family Center for Bipolar Treatment Innovation is seeking applicants for a Clinical Research Coordinator (CRC) position. The aim of the program is to evaluate psychiatric and psychosocial treatments for bipolar disorder, to learn more about the causes and general course of this disorder, and to investigate the pathophysiology of the condition with neuroimaging and other biological markers. Our program participates in large-scale, multi-site, NIMH, industry, and privately-sponsored initiatives. The CRC will manage and conduct a full range of research and clinical activities within the program. The CRC will assist in conducting clinical studies with the clinical and research staff.

PRINCIPAL DUTIES AND RESPONSIBILITIES: Indicate key areas of responsibility, major job duties, special projects and key objectives for this position. These items should be evaluated throughout the year and included in the written annual evaluation.

Responsibilities include structured patient interviews, patient recruitment, data collection and management, grant preparation, Institutional Review Board correspondence, phlebotomy (drawing blood), as well as other key administrative tasks. The CRC will also be offered the opportunity to assist with data analysis, neuroimaging (MRI), and preparation of poster presentations, symposiums, and manuscripts. The CRC will also answer triage phone calls, conduct phone screens, participate in case reviews to determine patient's eligibility and make referrals. A key component of the position includes assisting in grant proposals for future clinical trials. The CRC will liaise with Research Management at Massachusetts General Hospital, the funding agency, as well as help prepare aspects of the proposal, such as the budget.

The primary research projects the CRC will work on may include, but are not limited to psychosocial interventions (e.g., mindfulness-based, cognitive behavioral, lifestyle changes), medication-based trials (e.g., new medications, dose response, examination of side effects), and online and mobile phone based studies. A Bachelor of Science or Bachelor of Arts is required. A strong background in psychology, biology, and/or health sciences is preferred. Prior research, statistical, and/or clinical experience is strongly recommended. The CRC will collaborate with other members of the research team, faculty and staff of the Dauten Center, but will also be expected to take the initiative and work well independently. Excellent attention to detail, organization, strong interpersonal skills, great writing skills and being able to manage multiple tasks simultaneously is a must. Candidates should have knowledge of basic statistical methods. Due to the deadline-sensitive nature of many projects, the pace of work may be demanding at times and requires prioritization. This position provides valuable experience for candidates interested in applying to graduate schools in clinical psychology or medical school. This is a paid full-time position (40 hours per week); a two-year commitment is highly encouraged.

QUALIFICATIONS: (MUST be realistic, neither overstated nor understated, and related to the essential functions of the job.)

- Bachelor's degree required.

- A strong background in psychology, biology, and/or health sciences is preferred

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED: (MUST be realistic, measurable, objective, and related to the essential functions of the job.)

Please note, the functions below are representative of major duties that are typically associated with these positions. Specific responsibilities may vary based upon departmental needs. Similarly, not all duties that have been outlined will be assigned to each position.

- 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 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 I 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

- Ability to be flexible and able to manage multiple tasks in several projects at once

The Clinical Research Coordinator I 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

WORKING CONDITIONS: Describe the conditions in which the work is performed.

We are currently working in a hybrid model (e.g., part remote and in-person work) and expect this to continue for the foreseeable future.

SUPERVISORY RESPONSIBILITY: List the number of FTEs supervised.

A Clinical Research Coordinator I may assist in supervising and training Clinical Research Interns