Working under the general supervision of the Principal Investigator and the Research Nurse, the RA will be responsible for the various day-to-day activities of lung transplant clinical studies team. The Lung transplant team conducts clinical research that is funded by corporate, foundation and federal funds. This is a growing research program. Responsibilities include; development and implementation of patient recruitment/retention strategies and goals and organization and completion of IRB and regulatory documents, appointment scheduling. In addition, the candidate will track milestones and perform invoicing.
- Act as primary liaison between all levels of research staff including Data Coordinating Center, Research Network, Research Pharmacy, Sponsor and Monitoring Companies.
- Document reportable events and other major concerns related to the studies and disseminate the information to the PI, IRB, Data Coordinating center and Sponsor
- Meet with monitors as requested by sponsors to ensure Food and Drug Administration (FDA) compliance, Good Clinical Practice (GCP) guidelines of research data collection.
- Enter Data into Case Reports Forms (CRFs) and Electronic Data Capture (computerized CRFs)
- Track milestones for studies and assist in billing for corporate studies or capitated federal projects.
FDA/ Sponsor Regulatory:
- Work with PI and research staff to submit, manage and maintain all IRB documentation, including new research study submissions, annual continuing reviews, amendments as needed, study advertising and recruitment materials, as well as patient/physician letters.
- Ensure that all documentation maintained for each study is readily available for review by study staff, PI and monitors as necessary.
- Monitor and reports serious adverse events as required by institution/federal regulations.
- Manage and update ICF forms as required by sponsor, site or FDA and ensure that ICF forms are Health Insurance Portability and Accountability Act (HIPAA) compliant.
- Maintain regulatory binders, including, financial disclosure forms, medical licenses for physicians and study staff, completed FDA 1572 forms and signed CV's for all study staff.
- Verify accuracy and completion of all study forms, update forms as required by the FDA, sponsor and/or study site, and forward copies of all documents to both the sponsor and the monitoring companies.
- Maintain patient visit logs, pharmacy and site visit personnel logs.
- Resolve all queries to facilitate sponsor presentation of data to FDA. This entails reviewing queries with PI regarding adverse events, obtaining information from sponsor regarding similar adverse events, follow-up telephone calls to patients with specific details of adverse events, including medical intervention, hospital stays, emergency room visits, or unscheduled physicians visits, and ongoing treatment.
- Obtain pertinent medical records relating to serious adverse events including admission/discharge summaries, operative notes, and in-patients notes.
- Screen and interpret information given to determine subject eligibility for research study enrollment.
- Maintain patient visit schedules throughout study including phone calls to subjects per protocol schedule.
- Perform EKG's, vital signs, phlebotomy, assist in procedures, and coordinate diagnostic tests with other departments when applicable.
- Administer Questionnaires, collect and organize subject data.
- Assist patient by educating them of study specifics including drug/device usage, side effects, importance of research study compliance and emergency contact information while enrolled in study.
- Register patients in protocol-specific database.
- Follow up and report data collection necessary for protocol (blood work, microbiology results, ECG etc) and fill out necessary CRF's.
- Follow up on the status of adverse events and the continuing usage of concomitant medications.
- Travel to coordinator training sessions and meetings may be required.
- All other duties as assigned
- BS. MS or knowledge gained by equivalent work experience preferred.
- At least 2-3 years of work experience in a research setting with clinical background.
- Strong attention to detail and good organizational skills.
- Good interpersonal skills with patients/ study subjects / team
- Careful attention to detail and organization
- Good oral and written communication
- Ability to demonstrate professionalism in the workplace in regard to patient needs.
- Knowledge of HIPAA regulations preferred
- Knowledge of OSHA regulations preferred
- Maintain necessary job required licensure and attend job related training/education courses.
Brigham and Women's Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, sexual orientation, protected veteran status, or on the basis of disability.