Manages multiple concurrent moderately complex clinical trials that may include national level and multi-institutional pharmaceutical.
Responsibilities include, but are not limited to, recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring protocol adherence.
Plans and coordinates subjects schedule for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events.
Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.Â
Identifies adverse events and protocol deviations or violations, reports findings to PI, sponsor and IRB under general direction of clinical research manager.
Organizes and actively participates in site visits from sponsors and other relevant study meetings.Â
Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.
Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol. Responsibilities include, but are not limited to, provides efficient and complete data collection, processing, analysis and reporting; assures source documentation and data abstraction and entry are being done at the protocol specified time-points; ensures data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and, facilitates the exchange of data across projects and organizations.
Protect patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols.
Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency specifications.Â
Works closely with Regulatory Manager to maintain accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, and study related communication.
Ensures compliance with federal regulations and institutional policies.
May mentor CRC1 or other CRC2 staff on the basics of clinical research, Good Clinical Practice (GCP), Good Documentation Practices (GDP), Standard Operating Procedures (SOPs) and other related aspects of the clinical study.
Analyzes protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.
Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
Performs other related work as needed.
Continuing education such as ACRP, SoCRA or the Graham School Clinical Trials Management & Regulatory Compliance certification.
Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, and multi-site trials).
Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines.
Demonstrated ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.
Strong organizational skills.
Strong communication skills (verbal and written).
Strong data management skills and attention to detail.
Ability to participate in protocol review and clinical trials evaluations.
Knowledge of medical terminology/environment.
Ability to handle competing demands with diplomacy and enthusiasm.
Excellent time management and ability to prioritize work assignments.
Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat.
Familiarity with Good Clinical Practices (GCP).
Ability to read and understand clinical trials protocols.
Understanding of the IRB submission and review process and when and how to apply for IRB review.
Understanding of the federal research regulations and the ability to identify the federal research organizationsâ™ role in regulating human research participation.
Ability to absorb large amounts of information quickly.
Cover Letter (required)
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