The MGH Division of Pulmonary and Critical Care Medicine has an active and growing program in clinical and translational research. Our investigators study a variety of lung diseases including chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), pulmonary hypertension, pleural effusion and acute lung injury. The individual hired for this position will receive general direction from the Senior Project Manager for Clinical Research and the Vice Chief for Research and will work as part of a team of clinical research coordinators to ensure successful study start-up, enrollment and close-out in compliance with MGH, Partners, NIH and FDA regulations and guidelines. Prior experience coordinating clinical research studies is strongly preferred.
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.
Ability to work independently in all phases of clinical research: initiation, coordination and close-out.
Initiation: Complete and submit IRB applications and related documents, review and prepare budgets, prepare documentation for approval of budget and clinical trial agreements
Coordination: Recruit study participants and verify suitability using inclusion/exclusion criteria, maintain case report forms, regulatory binders and study databases, participate in meetings with study staff, interact closely with principal investigators to ensure enrollment and retention, review quality of data with study monitors, prepare adverse event reports for the IRB and sponsor, maintain record of payments from sponsor
Close-Out: Maintain documentation for study participant binders, CRFs, and regulatory binder; prepare final report of study and submit to IRB; resolve any adverse events with study participants, return rental equipment or study material to sponsor, prepare for audit if necessary
Assist principal investigator with the management of research study
Organize data and review study results with PI
Prepare documentation for IRB on study progress
Prepare annual continuation report, study progress report and obtain renewal of informed consent.
Submit protocol amendments to the IRB
Perform study procedures and tasks
Enter and maintain accurate databases including daily back-up
Prepare for sponsor-initiated or for-cause audit
Comply with regulatory requirements, hospital policy and good clinical practices
Serve as a resource for study participants and their families
Develop and maintain knowledge of current regulatory requirements and policies for relevant agencies (Partners, MGH, FDA, NIH, etc.) through seminars and other training opportunities
Perform study rstudy-relatedand procedures
Order study-related supplies
Maintain study codes
Obtain patient data from medical records, physicians, etc.
Schedule study appointments
Escort patients to appointments
Provide basic ea explanation of the study
Administer and evaluate study questionnaires
Document patient visits and procedures
Perform procedures including phlebotomy, nasal swabs, EKG, vital signs, collection of exhaled condensates, and spirometry
Store and ship specimens
Meet on a weekly basis with supervisor to discuss study related issues, problems and concerns
Meet on a weekly basis with study PI to review all aspects of study.
Maintain clear and accurate records (written and electronic).
Prepare study progress reports.
Interact with sponsor and regulatory agencies
SKILLS/ABILITIES/COMPETENCIES REQUIRED: Must be realistic, objective, measurable and related to essential functions of this job
Careful attention to details
Good organizational skills
Ability to follow directions
Good communication skills
Knowledge of clinical research protocols
Bachelor's degree required. Master's prefered
Minimum of 1-2 years of directly related work experience in clinical research
A Clinical Research Coordinator II may assist with the training and orientation of new staff members.
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.
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