Coordinates all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
Assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.
Provide support to other CRC and research-related staff Â as needed.
Maintain accurate and complete records which may include (but are not limited to) signed informed consents, source documentation, Case Report Forms, drug dispensing logs, and study related communication.
Independently assess for protocol deviations or violations.
Prepares and maintains protocol submissions and revisions.
Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects.
â‹Performs assessments at visits and monitors for adverse events.
Organizes and attends site visits from sponsors and other relevant study meetings.
May recruit and interview potential study patients. May obtain, possess, and transport specimens to appropriate laboratory according to established aseptic techniques.
Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Participates in study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
Performs other related work as needed.
Knowledge of medical terminology/environment.
Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.
Ability to communicate with tact and diplomacy.
Strong organizational skills.
Strong communication skills (verbal and written).
Excellent interpersonal skills.
Strong data management skills and attention to detail.
Knowledge of Microsoft Word, Excel and Adobe Acrobat.
Ability to understand complex documents (e.g., clinical trials).
Ability to handle competing demands with diplomacy and enthusiasm.
Ability to absorb large amounts of information quickly.
Adaptability to changing working situations and work assignments.
Cover Letter (required)
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