GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Diabetes Research Center (DRC) at Massachusetts General Hospital seeks a highly motivated individual to assume the position of Clinical Research Coordinator (CRC). This individual will work as part of a dynamic and enthusiastic team of diabetes doctors, nurses, and educators under the general supervision of the Clinical Research Manager and the Principal Investigator (PI). This position offers the opportunity to work directly with research participants, nurses, and physicians and learn about clinical research in a large academic center.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

General tasks will include:

• Complete all required hospital, department level, sponsor, and protocol training including phlebotomy and proper shipping, handling and transporting of human bio-samples.
• Ensure thorough familiarity with study protocols and manual of procedures.
• Participate in ongoing education in clinical research through the hospital offered programs.
• Foster positive interactions with research participants, families and clinic staff.
• Adhere strictly to all HIPAA regulations and institutional patient confidentiality requirements.
• Establish an effective working relationship with the project team and center management demonstrating respectful relationships and clear, effective and considerate communication.
• Effectively plan and complete assignments in a timely manner.
• Demonstrate superior organization skills.
• Participate in and chair center committees.
• Participate in quarterly Quality Improvement initiatives across multiple research teams and protocols throughout the DRC.
• Participate in rotating schedule to provide support for DRC operations and other study teams.
• Participate in travel within the US.
• Attend mandatory weekly staff meetings, mandatory monthly center staff meetings and all other activities and trainings as required.
• Participate in literature review and scientific writing.
• Other study related or administrative responsibilities as assigned.

Specific duties include:

Clinical Study Operations:

• Communicate with the PI and study team regarding all aspects of the recruitment, enrollment, and the implementation of the research protocol.
• Pre-screen potential participants for study eligibility.
• Recruit participants through modalities including, but not limited to, recruitment registry and medical record review, mailings, online research postings, advertisements, and social media.
• Serve as a contact for participants/potential participants prior to enrollment and throughout the duration of the study.
• Coordinate initial and follow-up study visits (i.e. scheduling, collecting blood and urine samples, collecting and organizing data, data entry, maintaining the study database, responding to edits and queries, and coordinating the schedules of staff members and off-site facilities).
• Administer questionnaires, set up files and paperwork, and ensure accurate/compliant records for each study visit.
• Gather measurements such as height, weight, blood pressure, and others as needed per study protocol.
• Download medical devices and process the data, including continuous glucose monitors, glucose meters, ketone meters, insulin pumps, insulin pens, and investigational devices.
• Collect and collate participant medical records from within internal record systems and via external record requests.
• Organize and maintain cloud-based database of current and archived research data in Lab Archives.
• Perform phlebotomy to collect blood samples.
• Collect urine samples.
• Process blood and urine samples per protocol.
• Ship blood, urine and tissue samples in accordance with established procedures.
• Manage laboratory space including cleaning, stocking and completing supply inventory.
• Maintain inventory of all frozen samples and serve as a contact for freezer alarms.
• Log temperatures and maintain responsibility for refrigeration systems used for study medications and samples.
• Review data to ensure completeness and accuracy of information and follow up with staff or participants as needed to resolve problems or obtain clarification.
• Complete regular inventory of study supplies and efficiently order supplies maintaining a minimum stock required for the study.
• Conduct routine equipment maintenance, schedule equipment inspections, maintain inventory of equipment and communicate with DRC management regarding inspections and receipt of new or disposal of old equipment.

Regulatory & Administrative Support:

• Interact with regulatory agencies such as the IRB and/or sponsors and complete necessary filings; assemble and maintain regulatory and participant binders.
• Schedule and coordinate study meetings; draft agendas and minutes.
• Request, process, and track purchase orders, checks, and invoices.
• Maintain staff files for training/regulatory matters, process staff travel reimbursement for study visits.
• Answer main phone line and the door as needed, and other duties as assigned by manager.
• Assist with preparations for and participate in all site monitoring visits or audits for current and inactive protocols.
• Coordinate with collaborators and vendors to make sure all of the required materials are available in a timely fashion.

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 manage time independently, effectively, and juggle multiple tasks, people, and schedules
• Ability to demonstrate respect and professionalism for subjects' rights and individual needs
• Flexible in both work hours (such as 6:30 am start) and days (may involve some weekends or evenings) to accommodate research visits

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.

SUPERVISORY RESPONSIBILITY (if applicable):

• N/A

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.