GENERAL SUMMARY/ OVERVIEW STATEMENT:
The Liver 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). This position has a strong focus on management and enrollment of investigational treatment studies. The research coordinator candidate will be responsible for all study tasks related to 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. Additionally, the research coordinator will serve as the primary contact for potential study participants and in coordination with the physician investigators perform study visits and assessments.
The ability to work independently 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 possess a biology background and also have prior clinical research or healthcare experience. Additionally, experience in customer service, a keen interest in the medical field and ability to start in late April 2021 is strongly preferred.
This position offers the opportunity to work directly with patients, nurses, and physicians and learn the basics about clinical research in a large academic medical center.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
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.
- 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
- Track study milestones and assist in invoice preparation and reconcilliation
- Attend regular meetings with project team (both internal and external sponsors) and prepare reports of work performed and projects in process
- 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 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
- Working knowledge of FDA regulatory requirements and Good Clinical Practice
- Prior experience working with Clinical Reseach Organizations (CROs) and Clinical Research Associates (CRAs)
- Prior experience working with Partners Human Research Comittee (PHRC), Western Institutional Review Board and Advarra IRB strongly preferred.
- Bachelor's degree required.
- Minimum of 1-2 years of directly related work experience in a healthcare or clinical research setting.
- Prior experience with industry sponsored investigational new drug trials strongly preferred
- Candidates with experience in both academic and commercial Institutional Review Board (IRB) submissions and protocol management will be prioritized.
- The Clinical Research Coordinator may assist with the training and orientation of new staff members.
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.