Demonstrates ability to screen participants for study eligibility & enroll with accuracy in various databases.
Performs simple study procedures with accuracy.
Understands protocol structure and how to interpret study requirements to ensure study compliance.
Understands proper documentation techniques as outlined in the ICH-GCP guidelines.
May complete simple study reimbursement with partners such as the Human Subjects Incentive Program (HSIP) and the CTSU finance team.
Demonstrates the ability to find and utilize information from EMR and databases/CTMS/EDC.
May mark visits as planned/occurred in OnCore.
May provide lab results, not interpretation, to participants.
May maintain essential regulatory documents.
May assist research coordinator in conduct of SIV; attends SIV.
May assist in and attends monitor visits and or audits.
May conduct site selection/qualification visits for potentially incoming clinical trials.
Demonstrates the ability to complete simple data collection during study visits (e.g., basic demographic information).
Enters data to complete forms (CRFs) on paper, databases, or EDCs.
Assists with collection of external medical records, CLIAs, CAPs, and radiology CDs as assigned.
May administer minimal risk consents, surveys, and questionnaires.
Checks own work and confirms accuracy.
Demonstrates ability to perform concomitant medications abstraction.
Uses various NCI AE grading scales.
Builds patient research study charts.
Demonstrates ability to resolve simple queries.
Assists in quality control efforts (e.g., review of consents for signatures)
20% Regulatory Coordinator Responsibilities (ex. May work with regulatory support to collect essential documents and maintain regulatory binder (CVs, MD licenses, lab certifications, IRB rosters, lab norms, etc.); Assists with AEs and SAEs, ORIOS reporting; Uses proper documentation techniques as outlined in the ICH-GCP guidelines.)
30% Administrative Responsibilities (ex. Provide other administrative support for study activity including scanning, filing, etc. of research documents; managing organization of research kits.)
Demonstrates understanding of the clinical research objectives associated with the program.
May communicate with study participants such as sending study correspondence via mail or email.
May schedule subjects for research visits and FU appointments.
May check study calendar for completion of study procedures.
May manage study supply inventory.
May utilize documents and systems to track recruitment and retention of participants.
May complete and activate postings (advertisements, flyers, etc.) independently.
May work with regulatory support to maintain regulatory binder (CVs, MD licenses, lab certifications, IRB
rosters, UM lab norms, etc.)
10% Training (ex. May receiving task specific training to perform additional research duties as assigned.)
PEERRS, HIPAA, CITI GCP
Gains appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned.
Willing to learn and use available technology and systems to accomplish job requirements.
Understands the disease process per program.
Attends and participates in all training classes assigned to this level.
Supervision Received: This position receives direct supervision and reports directly to a CRC-Senior.