Clinical Research Coordinator

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Clinical Research Coordinator (CRC) is an integral member of an interdisciplinary research team, which supports the clinical studies in the Neuroendocrine Unit (Department of Medicine) that are focused on the endocrine regulation of eating behavior and metabolism in eating disorders and obesity. Under the supervision of a nurse practitioner and the principal investigators, the CRC will carry out a broad range of research activities and procedures as described below.

Research study: The Research program focuses on the neurohormone oxytocin in human physiology and pathophysiology and therapeutic potential in human disease; and the neurobiology of eating disorders and obesity. Specifically, the CRC will support a study investigating the effects of oxytocin in adolescents with obesity. The CRC may have the opportunity to be involved in other clinical research studies in the Neuroendocrine unit.

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.

PRIMARY DUTIES AND RESPONSIBILITIES:
• Develop and implement strategies to recruit volunteers to participate in clinical trials.
• Interview (prescreen) prospective volunteers and determine their eligibility to participate in the study with guidance from NPs, study clinicians, and PIs.
• Schedule and conduct study visits with volunteers, including assessments such as conducting interviews, administering computerized questionnaires, and collecting biological samples (e.g., pregnancy tests, blood draws). Training provided.
• Review test results and data with the nurse practitioner, study clinicians, and principal investigators to ensure that protocol requirements are met and that abnormalities are addressed by clinicians.

• Collect and organize subject data (i.e., medical records, lab reports, MRI/CT reports etc.)

• Enter and maintain all data collected from medical charts and study databases.

• Develop meeting agendas, present/guide discussion related to agenda topics, and document meeting notes. Be prepared to report on study progress.

• Manage study drug accountability; maintain inventory of study supplies and long-term storage of biological samples, including preparation for shipment for batch testing. Work in -80°C freezers (specimen storage)
• Work with human specimen samples (i.e., blood, urine, saliva etc.) using standard biosafety precautions.

• Maintain subject charts, regulatory binders and studydatabases. Communicate with the IRB and other various research regulatory bodies with guidance from NPs and PIs. Complete applications, periodic reports, and related forms and ensure timely submission to regulatory bodies overseeing the clinical study's such as the Institutional Review Board (IRB), the Food and Drug Administration, and funding groups (e.g., NIH, industry sponsor).
• Serve as a primary contact for urgent clinical research matters.
• Able to work on-site during normal business hours with the flexibility to attend study visits that may occur during early mornings, evenings, and (rarely) weekends.
• Full-time, 2-year position.
• Preferred start date May/June 2024.

ADDITIONAL DUTIES AND RESPONSIBILITIES:
• Act as study resource for subjects and the study staff.
• Perform study procedures such as phlebotomy, EKG, structured psychological interviews (training provided).
• General clerical tasks (e.g., filing, copying) and creating kits/labels for the collection and storage of biological samples.

• Escort subjects to and from study visits components located in different hospital departments/buildings.

• Conduct structured clinical interviews for psychiatric disorders, including eating disorders and suicidal ideation. Training and supervision with clinical psychologist provided.
• Create and maintain a variety of study related logs, including billing logs.
• Use software programs to generate statistical graphs and reports.
• Assist with formal audits of data and study documents.
• Assist with creating and making recommendations to update consent forms, study protocols and amendments, and other study-related documents.
• Ability to assist with preparing data and related information for abstracts, posters, or manuscripts.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:
• Careful attention to details and outstanding organizational skills.
• Strong interpersonal skills and ability to demonstrate respect and professionalism for subjects' rights and individual needs.
• Excellent written and verbal communication skills.
• Ability to manage multiple responsibilities simultaneously and shift priorities as needed.
• Ability to work independently and as a team player.
• Working knowledge of clinical research protocols.
• Flexibility in working on different studies depending on program needs.
• Analytical skills and ability to anticipate, identify, and present solutions to resolve problems.
• Ability to interpret acceptability of data results.
• Computer literacy including the use of Microsoft Office.
• Working knowledge of electronic data capture systems.

Qualifications

EDUCATION:
• Bachelor's degree required.

Language
• Spanish speaker strongly preferred.

EXPERIENCE:
• New graduates with some relevant course/project work or those without any prior research experience will be considered for a Clinical Research Coordinator I position.
• Candidates with a minimum of 1-2 years of directly related work experience will be considered for a Clinical Research Coordinator II position.

SUPERVISORY RESPONSIBILITY:
• A Clinical Research Coordinator I or II may assist with hiring, supervising, and mentoring clinical research interns.
• A Clinical Research Coordinator II may assist with the training and orientation of new staff members.

EEO Statement

Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.