Clinical Research Coordinator - Liver Center NALFD Group
The Non-Alcoholic Fatty Liver Disease (NAFLD) Research 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 central focus of this position is in the care of patients with NAFLD. Currently, there are no FDA approved medications for NAFLD and a significant proportion of patients will go on to develop end stage liver disease, liver cancer or need a liver transplant. The MGH NAFLD Research Group is devoted to studying the risk factors for NAFLD through enrollment and follow-up of patients in a long-term cohort as well offering patients with NAFLD the opportunity to participate in cutting edge clinical trials. Our research coordinators are essential to our patients and for our studies. They are charged with guiding patients through studies and they develop rewarding, longitudinal relationship with patients. The research coordinator candidate must be enthusiastic about research, motivated to help make scientific breakthroughs and enjoy talking and caring for patients and conducting study visits. Study coordinators will also be charged with the essential tasks of study start-up including; completion and collection of regulatory documents; preparation and submission of Institutional Review Board (IRB) applications; coordinating trainings between staff and vendors and identification of potential study participants. Coordinators must also have comfort with data entry and organization, essential skills for scientific research.
The ability to work independently, problem solve and to organize workflow efficiently is a must. The schedule will require flexibility and may include occasional early mornings and evenings depending on time-management and patient schedules. An ideal candidate would have prior clinical research or healthcare experience or strong people and organization skills. Experience in customer service and have a keen interest in the medical field is valued.
This position offers the opportunity to work directly with patients, nurses, and physicians and become immersed in clinical research in a large academic medical center.
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.
Clinical Trial Responsibilities
- Manage study operations and ensure integrity of study
- Facilitate IRB submission process by preparing protocol applications, protocol amendments, safety reports, adverse event reports and other required documents.
- Manage and maintain regulatory documents for audit by sponsor or FDA.
- Develop and implement project workflows and standard operating procedures
- Assist recruitment and/or randomization of subjects per study protocol
- Act as primary study resource for lab staff, patients and families
- Arrange and conduct initial interviews of study subjects and evaluate criteria for inclusion/exclusion per study protocol; coordinate subsequent assessments of subjects as outlined in study protocol
- Assess subject’s health through interviews; take subjects vital signs
- Perform phlebotomy on subjects; process and ship specimens
- Evaluate medical records and laboratory results for study relevant clinical data
- Coordinate subject care by scheduling follow-up assessments and communicating concerns about the subject with the study investigator and the subject’s primary care provider
- Maintain subject charts and other data per the protocol and assess data for quality and completeness
- Conduct ongoing review of study progress and provide investigators with progress reports
- Attend regular meetings with project team (both internal and external sponsors) and prepare reports of work performed and projects in process
Fiscal Responsibilities
Study coordinator will be responsible for submitting and tracking sponsor invoices for milestone payments. In coordination with the research grant manager, CRC will review and reconcile study funds against invoices and follow-up on outstanding payments.
SKILLS/ABILITIES/COMPETENCIES REQUIRED:
- Excellent analytical skills and the ability to resolve technical or research problems and to interpret the acceptability of data results
- Highly motivated, self-directed and driven to meet study goals
- Excellent problem solving skills and ability to independently troubleshoot where approrpriate
- Excellent communication skills and willing to assume study leadership role
- Ability to manage time independently, effectively and efficiently
- Ability to juggle multiple tasks, people and schedules.
- High degree of computer literacy, knowledge of Microsoft Office suite
- Excellent organization skills and ability to prioritize a variety of tasks
- Ability to demonstrate professionalism and respect for subjects’ rights and individual needs
- Excellent people skills, ability to reach out to perspective study patients to discuss study interest
EDUCATION:
- Bachelor’s degree required.
EXPERIENCE:
- Customer service experience preferred
- Prior experience with industry sponsored investigational new drug trials valued but not essential
- Candidates with experience in both academic and commercial Institutional Review Board (IRB) submissions and protocol management will be prioritized.
- 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. Those 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 does not have any supervisory responsibility.
- A Clinical Research Coordinator II may assist with the training and orientation of new staff members.
WORKING CONDITIONS
- Hybrid position with ability to work remote 1 day/week.
- Candidate must be able to lift/carry up to 25 pounds.
- Day shift with flexibility for evening/weekends depending on time management and patient schedules
- Position includes conducting subject visits within a medical office setting, and handling biological specimens following universal precautions for blood/stool processing, handling and shipping.