Clinical Research Coordinator
Massachusetts General Hospital(MGH)

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Inflammatory Bowel Disease (IBD) Group in the Digestive Healthcare Center at the Massachusetts General Hospital seeks a highly motivated, self-directed individual for the position of Clinical Research Coordinator (CRC). The mission of our team is to produce research to advance the care for understudied patients with IBD. Specifically, we are looking for someone to assist in our clinical and translational research endeavors by helping with the clinical research process, patient recruitment and potentially specimen collection. Our research studies involve epidemiological studies of previously collected data, building prospective cohorts and working with collaborators at other institutions .

The selected candidate will work independently to coordinate clinical research projects under the direct supervision of the principal investigators, and with the support of an established team of clinical research coordinators. The candidate will be responsible for all study tasks related to patient recruitment and data management. These tasks include: institutional review board submissions, chart reviews, subject recruitment and enrollment, arranging follow-up study visits and phone calls, capturing clinical data. It may include scheduling and performing blood draws, processing, aliquoting and shipping biologic specimens, and maintaining database with results. Thus, the candidate will be expected to interact directly with study participants, physicians, administrators and regulatory personnel.

The candidate will work full time (40 hours/week), however the schedule will require flexibility and may include occasional evenings depending on time-management and patient schedules. The research studies will continue for approximately 2 years or more. This research environment is highly conducive to individuals interested in eventually pursing medical, graduate, or public health advanced degrees. There will be mentored opportunities for publication and presentation depending on the candidate's interest.

This position offers the opportunity to work directly with patients and physicians, and it will provide foundational skills in conducting clinical research in a large, academic medical center.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• • Recruit and enroll eligible study participants from clinics throughout the hospital
  
  • Arrange and conduct initial interviews of study subjects and evaluate criteria for inclusion/exclusion
  
  • Perform Institutional Review Board (IRB) submission process by preparing protocol applications, amendments, safety reports, adverse event reports and other documents
  
  • Capture clinical information from record review and patient interview into study database
  
  • Perform bio-specimen processing, aliquoting, tracking and shipping
  
  • Keep bio-specimen electronic and physical inventories current and available
  
  • Manage and maintain regulatory documents for audit by FDA, as needed
  
  • Prepare and manage regulatory documents for audit by FDA, as needed
  
  • Act as primary study resource for laboratory staff, patients and families
  
  • Evaluate and update medical records and maintain study database
  
  • Coordinate subject care by scheduling and arranging follow-up visits, conducting follow-up telephone calls, and communicating concerns with the study investigator
  
  • Conduct regular review of study progress and follow-up
  
  • Attend weekly coordinator meetings, and prepare weekly reports of work performed
  

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:

• Excellent interpersonal, verbal and written communication skills in English

• Ability to manage time effectively

• Ability to work independently and as a collaborative team member

• Ability to maintain accurate records

• Ability to organize, analyze, summarize, and present data

• Experience in a clinical environment or biobanking preferred

• Experience and proficiency in biospecimen (blood, stool, tissue, urine) handling preferred, but not required

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

WORKING CONDITIONS:

• Position includes conducting subject visits within a medical office setting and handling biological specimens following universal precautions for blood processing, handling and shipping.

Day shift

Qualifications
EDUCATION:

• • B.A./B.S. degree required
  
  • B.A/B.S minimum 1-year experience is required for CRC II position
  

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.
• • Background in biology, immunology, biochemistry, biostatistics, epidemiology or related pre-medicine discipline preferred, but not required
  
  • Experience in a clinical research environment preferred
  
  • Experience working with older adults preferred
  
  

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.

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.

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