Clinical Research Coordinator at Careerbuilder in Boston, Massachusetts

Posted in Other 13 days ago.





Job Description:

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. This individual will work as part of a dynamic and enthusiastic team of diabetes doctors, nurses, and educators under the general supervision of the Nurse Director. This position offers the opportunity to work directly with research participants, nurses, and physicians and learn about clinical research in a large academic center.


The research coordinator will provide laboratory, organizational, administrative, and clinical assistance for designated research studies at the MGH Diabetes Research Center. The research coordinator's primary responsibility will be working on both local and nationwide studies of the investigational bionic pancreas in participants with diabetes.



PRINCIPAL DUTIES AND RESPONSIBILITIES:



Specific duties include:


  • Complete all required hospital, 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.

  • 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.

  • 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.

  • Complete regular inventory of study supplies and efficiently order supplies maintaining a minimum stock required for the study.

  • Maintain staff files for training/regulatory matters, process staff travel reimbursement for study visits.

  • 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.

  • Foster positive interactions with patients, participants, families and clinic staff.

  • Adhere strictly to all HIPAA regulations and institutional patient confidentiality requirements.

  • Attend staff meetings, answer main phone line as needed, and other duties as assigned by manager.

  • Participate in literature review and scientific writing.

  • Other study related or administrative responsibilities as assigned.






Qualifications

QUALIFICATIONS:



BA/BS degree required.


Proficiency in Microsoft Office Suite and computer literacy and data entry skills required.


Prior laboratory experience and biology background preferred.



SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:





  • Highly motivated and driven to meet study goals.

  • Careful attention to detail.

  • Excellent oral and written communication skills.

  • Creativity and resourcefulness in problem solving.

  • Attention to detail and strong organizational skills.

  • Ability to understand and follow specific protocols and procedures.

  • Ability to manage time independently, effectively, and juggle multiple tasks, people, and schedules.

  • Ability to maintain quality, safety, and infection control standards.

  • Adept at demonstrating professionalism and respect for participants' rights and individual needs.

  • Desire to interact with study volunteers and work as part of a dynamic team.

  • Ability to complete required hospital, departmental, and study specific training.

  • Flexible in both work hours (such as 6:30 am start) and days (will involve some weekends or evenings) to accommodate research visits.




WORKING CONDITIONS:



Laboratory, clinical research office, ambulatory clinical practice, and inpatient clinical setting.


The research coordinator will be interacting with research participants during study visits in an ambulatory clinic setting, and will be required to take measurements, collect data and collect blood and urine specimens according to institutional procedures. The research coordinator will work in a laboratory environment processing and shipping biological specimens including, blood and urine samples, and will be required to follow universal precautions for said specimens. The research coordinator will perform administrative and study coordination tasks in a clinical research office setting. The position will also include assisting with research visits in inpatient hospital units and off-site locations as needed.



SUPERVISORY RESPONSIBILITY:



N/A



FISCAL RESPONSIBILITY:



No direct fiscal responsibilities; however, will be involved in purchasing and monitoring supply orders, parking stickers, participant remuneration as needed.



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.