Sr. Research Assistant / Pulmonary / Full Time / Day / 3116926
Company: Brigham & Women's Hospital(BWH)
Posted on: January 17, 2020
Working under the general supervision of the Principal
Investigators, the RA will be responsible for the various
day-to-day activities of the lung transplant clinical and
translational research team. The Lung transplant team conducts
clinical and translational research that is funded by corporate,
foundation and federal funds. This is a growing research program.
Responsibilities include, completion of IRB and regulatory
activities required for study initiation and maintenance, visit
scheduling and coordination, tracking of study milestones and
perform invoicing, and implementation of patient
recruitment/retention strategies and goals.
* 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.
* 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
* Ensure that all documentation maintained for each study is
readily available for review by study staff, PI and monitors as
* Monitor and report serious adverse events as required by
institution/federal regulations, in collaboration with the site
* 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
* Maintain patient visit logs, pharmacy and site visit personnel
* 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
* Obtain pertinent medical records relating to serious adverse
events including admission/discharge summaries, operative notes,
and in-patients notes.
* Screen and interpret, in collaboration with site principle
investigator, information given to determine subject eligibility
for research study enrollment.
* Maintain, schedule and coordinate patient visits 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
* 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
* 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
* Follow up on the status of adverse events and the continuing
usage of concomitant medications.
* Travel to coordinator training sessions and meetings may be
* All other duties as assigned
* BS. MS or knowledge gained by equivalent work experience
* At least 3 years of work experience in a research setting with
clinical and translational background preferred.
* Strong attention to detail and good organizational skills.
* Good interpersonal skills with patients/ study subjects /
* Careful attention to detail and organization
* Good oral and written communication
* Ability to demonstrate professionalism in the workplace in regard
to patient needs.
* Self-motivated, able to function independently
* Comfortable working in fast paced work environment
* 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
Keywords: Brigham & Women's Hospital(BWH), Boston , Sr. Research Assistant / Pulmonary / Full Time / Day / 3116926, Healthcare , Boston, Massachusetts
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