Under limited supervision, coordinates the RIAO Research Program, including clinical trial regulatory affairs and clinical trial and research data coordination. Essential Functions include: Prepares regulatory documents and monitors regulatory activities for assigned clinical trials. Prepares protocol for initial and annual IRB (Institutional Review Board); submits protocol revisions and amendments for IRB review; submits Serious Adverse Events reports and Investigational Drug Safety Reports to ... more details
Summary
Under limited supervision, coordinates the RIAO Research Program, including clinical trial regulatory affairs and clinical trial and research data coordination.
Essential Functions include:
Prepares regulatory documents and monitors regulatory activities for assigned clinical trials.
Prepares protocol for initial and annual IRB (Institutional Review Board); submits protocol revisions and amendments for IRB review; submits Serious Adverse Events reports and Investigational Drug
Safety Reports to the IRB; maintains IRB correspondence documentation for study sponsor and cooperative group audits.
Prepares regulatory documentation binders for study monitoring and audits by National Cooperative Groups (NCG)/Pharmaceutical companies/FDA; assists in preparation of patient charts for audits and monitoring visits.
Prepares initial Informed Patient Consent forms for study participation; prepares form revisions when requested by study sponsor and submits for IRB review.
Manages the day to day regulatory/protocol maintenance operations of the assigned clinical trials.
Assists with the implementation of the clinical research agreement, study budget and investigator contract, review and submission; responsible for annual protocol/research agreement renewal coordination.
Assists physicians with obtaining protocols of interest; prepares and submits site assessment documentation and regulatory package to study sponsors; coordinates and facilitates pre-study, study initiation and study monitoring visits.
Develops data collection system to provide necessary patient and physician communication, report generation and statistical output; manages and augments system as necessary; inputs information into the database and verifies accuracy.
Assists Clinical Research Nurses with patient data collection and submits research data to the NCG according to the protocol regulations; assures compliance with standards set by research groups for continued participation
QUALIFICATIONS/REQUIREMENTS
Basic professional knowledge; equivalent to a Bachelor's degree; working knowledge of theory and practice within a specialized field
Education/Knowledge: Health Science/Public Health or related field.
Experience: 1-3 years
Additional Information
As one of the largest health care providers in Maryland, with 13,000 team members, We strive to CARE BRAVELY for over 1 million patients annually. LifeBridge Health includes Sinai Hospital of Baltimore, Northwest Hospital, Carroll Hospital, Levindale Hebrew Geriatric Center and Hospital and Grace Medical Center, as well as our Community Physician Enterprise, Center for Hope, Practice Dynamics, and business partners: LifeBridge Health & Fitness, ExpressCare and HomeCare of Maryland.
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