KPA 1 – Study Start-Up, Regulatory & Site Initiation
Responsible for supporting study feasibility, regulatory submissions, and study initiation activities to ensure compliance with protocols, regulatory requirements, and institutional policies.
•
Applies knowledge of study design to evaluate protocol feasibility at the site.
•
Assists Regulatory staff in preparing and submitting documents to Institutional Review Board (IRB).
•
Participates in study site initiation activities.
•
Attends and participates in investigator meetings and clinical trial conferences as directed.
•
Documents protocol deviations and exemptions.
•
Prepares for and participates in FDA inspections.
•
Communicates effectively with IRBs, sponsors, investigators, and research team members.
KPA 2 – Patient Recruitment, Screening & Enrollment
Responsible for patient recruitment, screening, eligibility verification, and enrollment activities in accordance with study protocols.
•
Participates in subject/patient recruitment and evaluation of eligibility.
•
Reviews and verifies required source documents to confirm study eligibility.
•
Reviews inclusion/exclusion criteria with investigator to assure subject eligibility.
•
Conducts interviews to assess subject ability and willingness to complete study procedures.
•
Maintains patient screening and enrollment logs.
•
Reviews protocol requirements, informed consent, and follow-up procedures with potential study subjects.
•
Follows randomization procedures per protocol.
•
Demonstrates commitment to superior customer service and patient-centered communication.
KPA 3 – Clinical Trial Coordination & Patient Care Activities
Responsible for coordinating study visits, performing clinical procedures, and ensuring protocol compliance throughout the research process.
•
Ensures study drugs are dispensed per protocol and maintains drug accountability records.
•
Reviews returned drugs for compliance and documents findings.
•
Provides direct care in study compliance throughout the research experience.
•
Performs peripheral venipuncture per organizational standards.
•
Ensures proper specimen collection, batching, processing, and shipping per protocol.
•
Works collaboratively with site staff to process specimens.
•
Prepares and ships study-required specimens per protocol manual.
•
Obtains test results and reports to the physician investigator.
•
Attends clinic visits with the investigator and assists in following study guidelines.
KPA 4 – Data Management, Documentation & Monitoring Support
Responsible for maintaining accurate study documentation, source documentation, and supporting sponsor monitoring and audit activities.
•
Obtains and reviews original source documents (recordings, scans, test results, procedure reports).
•
Abstracts data from medical records and other documentation to study forms and flow sheets.
•
Completes and maintains study documentation and case report forms.
•
Schedules sponsor monitoring visits.
•
Prepares case report forms and source documents for sponsor and audit review.
•
Assists with audit preparation and monitoring visits.
KPA 5 – Research Program Support, Education & Administrative Support
Responsible for supporting research department operations, education, budgeting support, and departmental coordination activities.
•
Participates in educational and training activities and continuing education.
•
Supports and assists management team with department projects.
•
Assists in maintenance of budgetary data for each clinical trial.
•
Assists in planning department coverage for clinic visits, data management, and meetings.
•
Maintains professional communication with internal and external customers.
•
Demonstrates strong verbal and written communication skills.