Under the general direction of the Clinical Program Manager for the Division of Transplantation, the Clinical Research Coordinator II assists with the screening, recruitment of study patients, and implementation of study procedures. The Coordinator will obtain informed consent once study patients have been identified and educated about the study. Management of patients occurs under Clinical Research Manager and general physician supervision. Patient data is collected from numerous sources including clinical chemistry lab, radiology, and other patient records related to specific protocols and put in research study databases.
Collaborates with supervisor to create and maintain a database of clinical protocol data. The Coordinator will be a resource for teaching other personnel about such databases. Carries out a wide range of moderate to complex data management functions with a full understanding of the principles underlying the choice and use of statistical tests; responsible for creation of graphics/slides for manuscripts and oral presentations. Collaborates with supervisor in writing and editing material for publication.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Coordinates multiple (up to 5) concurrent clinical research studies, with responsibilities including:
1. Recruitment/Enrollment - In conjunction with Clinical Research RN and various physician investigators in the Division of Transplant, develops and implements study recruitment strategies and procedures:
Drafts and prepares study consent forms for PI, IRB review;
Interviews/screens study subjects
Serves as study resource for patients and families;
Verifies subject inclusion/exclusion criteria;
Provides basic explanation of study and obtains informed consent from patients;
Schedule, set up paperwork and retrieve data for research subject visits
Escorts patients to appointments.
Meets with transplant clinical staff to discuss studies
2. Regulatory Compliance - With supervision from the PI and/or Clinical Research Manager, R.N., develops and maintains protocol specific documents, IRB amendments and reviews, and regulatory report submissions.. Duties include:
Verifies accuracy and updates study forms;
Assists with study regulatory submissions, including preparing and submitting regulatory documents to study data repositories
Maintains regulatory binders for trials in the Division of Transplant
Contributes to protocol recommendations and communicates these with Clinical Research Manager, RN;
Prepares protocols for review by the required hospital subcommittees: Pharmacy and/or IRB;
Drafts amendments to protocols, based on requests and suggestions by the P.I., and submits these for IRB approval;
Prepares annual renewal for the IRB Approval.
3. Data Management - Obtains and organizes patient data from medical records, physicians, etc., following HIPAA guidelines:
Study data entry;
Uses software programs to generate graphs and reports;
Maintains research data, patient and study files
Maintains study codes;
Assists with formal audits of data.
4. General Office & Laboratory Support:
Oversees bio-tissue collection and sample processing, per study protocol (including blood drawing protocols and clinical trials);
Ships and stores specimens, as required by protocol.
5. Assumes additional administrative and clinical research tasks, as needed.
SKILLS/ABILITIES/COMPETENCIES REQUIRED:
Extraordinary attention to detail, ability to work carefully and efficiently with limited supervision once appropriate training has been provided;
High level of proficiency with Microsoft Excel, Word, PowerPoint and computer data entry skills required;
Experience with medical chart reviews and electronic medical records (EPIC). Knowledge of database management strongly preferred;
Ability to interpret acceptability of data results;
Good judgment and problem-solving skills, ability to juggle multiple tasks, people and schedules
Ability to demonstrate professionalism, compassion and respect for study participants' rights and needs
Excellent oral and written communication skills in English
Ability to work both independently and as part of a busy, multidisciplinary team, interacting with diverse individuals at multiple levels within the research and clinical group
Work hour flexibility. Some visits start early in the morning (7 am) and there may be intermittent work after normal business hours
Qualifications
EDUCATION:
Bachelor's degree required.
1-2 years of Research related experience required.
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.
