CLINICAL RESEARCH COORDINATOR (304)

Affiliate Name: Brigham & Women's Hospital
Job Category: Research
Department: BWH DERMATOLOGY
Shift: Days
Hours/Week: 40
Job Type: Regular
Employment Type: Full TimeResponsibilities:
General Summary/Overview StatementThis position has responsibility to the Joint Clinical Trials Unit for Brigham and Women's and Massachusetts General Hospital. Responsible for all activities necessary to commence, conduct, manage, and closeout clinical trials and day-to-day implementations of study protocols.
Principal Duties and ResponsibilitiesIRB:
'Manage all IRB submittals to ensure receipt and approval.
'Prepare applications, advertising and recruiting letters, drug forms, radiation exposure forms, amendments and Investigational New Drug (IND) safety reports to the IRB documents for all new and existing study proposals.
'Complete annual continuing review reports for new and ongoing research projects.
'Develop and implement spreadsheets to record the total annual adverse events experience for all subjects in each protocol for the IRB.
'Monitor and reports serious adverse events as required by institution/federal regulations.
'Prepare documents for internal/external audits.
'Manage and update ICF forms as required by sponsor, site or FDA and ensure that ICF forms are the Health Insurance Portability and Accountability Act (HIPAA) compliant.FDA/Regulatory:
'Maintain regulatory binders, including signed CV's for all study staff, financial disclosure forms, yearly financial disclosure forms, medical licenses for physicians and complete FDA 1572 forms.
'Verify accuracy and completion of all study forms, update forms as the required by the FDA, sponsor and/or study site, and forward copies of all documents to both the sponsor and the monitor companies.
'Maintain patient visit logs, pharmacy and site personnel logs.
'Resolve all queries to facilitate sponsor presentation of data to FDA ' this entails reviewing queries with investigator regarding adverse events, obtaining information from sponsor regarding similar adverse events, follow-up telephone calls to patients regarding accuracy and timing of medications, time course and specific details of adverse events, including contacting outside physician's offices and emergency rooms to obtain medical records.Internal Responsibilities:
'Act as primary liaison between all levels of research staff, Research Management, Research Pharmacy, Sponsoring Pharmaceutical Company and Monitoring Companies.
'Document reportable events and other major concerns related to the studies and disseminate the information to the PI, Sub-I, Research Management 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)Financial:
'Manage project expenditures.
'Develop study budgets using self-created spreadsheets.
'Invoice Sponsors; prepare financial reports.
'Facilitate contract approvals.Administrative:
'Create and design case report forms for research studies following GCP guidelines.
'Implement changes to case report forms and blood collection forms mandated by HIPPA.
'Document conversations with patients, sponsors and monitors in a telephone log.
'Place advertisements for research subjects.
'Independently judge suitability of research subjects via telephone contact.
'Receive, inventory and organize study supplies.
'Order, inventory and organize office supplies.
'Implement storage of old study documents (labeling and recording in logbook) before shipping to offsite storage facilities.
'Future: design and implement Standard Operating Procedures for the Dermatology Clinical Investigations Unit.Training:
'Maintain required annual certifications for clinical researchers in IATA shipping, HIPPA compliancy, handling of specimens and clinical coordinator training programs.
'Attend off-site Investigator meeting to receive protocol-specific training programs.
'Assist in the training and orientation of new staff when applicable.Database:
'Design and update research database.
'Future: Oversee and organize the installation of the dermatology department photography software and server; will train staff in the importing of digital images; and program usage.Patient Visits:
'Verify and interpret data necessary for enrollment.
'Act as study resource for subjects and families, educate subjects per protocol and create study aids to assist subjects with taking study drug and protocol compliance.
'Register patients in protocol-specific database.
'Administer Questionnaires, collect and organize subject data.
'Perform EKG's, vital signs, assist in procedures, and coordinate diagnostic tests with other departments when applicable.
'Manage data collection necessary for protocol.
'Monitor and evaluate protocol compliance.
'Follow up on the status of adverse events and the continuing usage of concomitant medications.
'Record all of the information received from the medical record into the patients CRF and disseminate the information to the Sponsor.Research Pharmacy:
'Coordinate with the Research pharmacist regarding study drug preparation, distribution, labeling and prescriptions.
'Record Study drug distribution, dosage, randomize subjects to different drug groups, and responsible for replenishing study drug supply.
'Manage the labeling and storage of the study drug.
'Account for Study drug received from sponsor, distributed to patient, returned from the patient and to the sponsor.
'Responsible for replenishing study drug supplies.Laboratory:
'Performs phlebotomy.
'Process all specimens: centrifuge, pipette, capillary tube blood and transfer blood to toxic buffer, perform blood smears and urine pregnancy tests.
'Label all specimens properly before storing in the freezer of shipping, including paraffin wrapping of all specimens.
'Package specimens and fluids according to International Air Transport Association's (IATA) regulations for shipping dangerous goods by air.
REQUIREMENTS
'Bachelor's degree or equivalent work experience required.
'Clinical research experience with exposure to IRB preparation
'Certification in phlebotomy or willing to become certified within three months.