Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits.Â
Prepares program conference lists for multidisciplinary conferences and workshops. Participates in all pharmaceutical site visits. Uses moderate understanding of clinical trials to collect and store patient specimens, radiology scans and reports.Â
Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.Â
Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports with guidance from PI and other clinical research staff.â¯â¯Â
Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.â¯â¯Â
Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.â¯â¯Â
Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.â¯â¯Â
Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.â¯â¯Â
Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.â¯â¯Â
Performs assessments at visits and monitors for adverse events.â¯â¯Â
Organizes and attends site visits from sponsors and other relevant study meetings.â¯â¯Â
Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.â¯â¯Â
Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.â¯â¯Â
Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.â¯â¯Â
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: provide efficient and complete data collection, processing, analysis and reporting; assure source documentation and data abstraction and entry are being done at the protocol specified time-points; ensure data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and, facilitate the exchange of data across projects and organizations.â¯Â
Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.â¯â¯Â
Ensures compliance with federal regulations and institutional policies.â¯â¯Â
May prepare and maintain protocol submissions and revisions.â¯â¯Â
May assist in the training of new or backup coordinators.â¯â¯Â
Analyzes protocols and advise treating physicians on appropriate dosage modifications or treatment calculations.â¯Â
Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.â¯â¯Â
Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.â¯â¯Â
Accountable for all tasks in moderately complex clinical studies.Â
Assists with various professional, organizational, and operational tasks under moderate supervision.Â
Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.Â
Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence. Contributes to the problem solving on assigned clinical research studies and tasks. Â
Performs other related work as needed. â‹