Position Summary
Under direction, assists with the coordination, implementation and management of all aspects of clinical research studies
Job Responsibilities
Assists in the development of research designs.
Coordinates the recruitment and enrollment of study participants. Assesses patient eligibility for inclusion in clinical trials. Ensures proper consent protocols have been followed for study participation.
Advises study participants and families of trial activities and their rights as a study participant.
Performs monitoring of patients, collection and recording of clinical data.
Conducts patient follow up and arranges for diagnostic testing.
Analyzes research data using basic and advanced statistical methodologies; interprets results for clinical investigators and prepares reports.
Ensures strict adherence to study requirements according to guidelines set forth in the study protocol.
Coordinates specimen collection, transport, storage and processing.
Maintains ongoing records of trials for adverse events.
Provides sponsors with progress reports. Compiles subject data collection and submission of case reporting forms to sponsoring company. Produces summary data for each study and assists in the write up of completed projects.
Assists in database design programming and database management.
Coordinates and participates in site visits and audits. Ensures readiness and compliance. Addresses and resolves issues uncovered during visit/audit.
Assists with grant budgets and approvals.
Assists faculty in the preparation of grant submissions and associated documentation, which may include just-in-time documents, progress reports, routing forms, abstracts and manuscripts.
Creates IRB and/or IACUC protocols, submits for review/approval and maintains correspondence with sponsoring agency, IRB and collaborative institutions.
Maintains research effort tracking for principle investigators and key personnel.
Performs other related duties as assigned.
Education
High School Diploma
Experience
Bachelor's degree is preferred.
Approximately 2-3 years of experience in an administrative support role, ideally in a clinical, academic or research setting.
Knowledge, Skills and Abilities
Ability to take initiative and simultaneously manage multiple projects with minimal supervision.
Excellent communication skills (both verbal and written).
Demonstrated proficiency with MS Office Suite and database applications.
Licenses and Certifications
Working Conditions/Physical Demands
Standard office and laboratory space