Clinical Research Coordinator 2

Department

BSD MED - Hematology and Oncology - Clinical Research Staff - Cluster 10

About the Department

The Section of Hematology/Oncology has a proud and long tradition of excellence in research-based patient care and clinical discovery. Ranked among the finest cancer programs in the country, the Section is comprised of nationally and internationally known faculty with expertise in all major types of malignancies, blood disorders, and experimental therapies.

Job Summary

The Clinical Research Coordinator 2 (CRC2) is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of a departmental or lab research manager. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC2 supports, facilitates and coordinates independently the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties with limited supervision and/or guidance, the CRC2 works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

Responsibilities

• Manages all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.

• Recruits and interviews potential study patients with guidance from PI and other clinical research staff.

• Collects, processes, ships and stores specimens to appropriate laboratory according to established aseptic techniques.

• Identifies and explains the responsibilities of principal investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.

• Coordinates 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.

• Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.

• 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.

• Performs assessments at visits and monitors for adverse events.

• Organizes and attends site visits from sponsors and other relevant study meetings.

• Protects patients' and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.

• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.

• 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.

• Understands 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.

• Ensures compliance with federal regulations and institutional policies.

• May prepare and maintain protocol submissions and revisions.

• Assist in the training of new or backup coordinators.

• 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.

• Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.

• 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.

• Accountable for all tasks in moderately complex clinical studies.

• Performs other related work as needed.

Minimum Qualifications

Education