Clinical Research Coordinator II, Surgery

About the role

The Clinical Research Coordinator II (CRC2) works with the Principal Investigator (PI), Co-Investigator(s) and other study personnel. They manage multiple moderately complex clinical trials, recruit and screen study subjects, obtain informed consent, enroll subjects in research studies, collect and analyze research data, complete case report forms (CRFs), adverse event reports, and ensure protocol adherence. They also conduct sponsor-related visits, participate in study start-up activities, process and collect samples, plan and coordinate subjects' schedules, educate subjects about study procedures, perform assessments, identify adverse events and protocol deviations or violations, and report findings to the PI, sponsor, and IRB.

Responsibilities

• Research Conduct/Study Management
• Recruits and screens study subjects, obtains informed consent, enrolls subjects in research studies, subject follow-up, collects and analyzes research data, completes CRFs, adverse event reports, and ensures protocol adherence.
• Conducts all sponsor-related visits and acts as a liaison between sponsor and PI.
• Reviews and meets regularly with PI to review study portfolio.
• Participates in study start-up activities.
• Works with the lab team to process and collect samples for internal processing.
• 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.
• Captures, processes, ships, and stores specimens to appropriate laboratories according to established aseptic techniques.
• 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.
• Maintains a safe research environment and ensures compliance with governmental and University policies, procedures, and regulations.
• Data Management
• Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol.
• Ensures data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries.
• Facilitates the exchange of data across projects and organizations.
• Protects 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.
• Regulatory Compliance
• 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.
• Other
• Assists with various professional, organizational, and operational tasks under moderate supervision.
• 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.
• 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.
• Performs other related work as needed.

Requirements

Minimum Qualifications:

• A college or university degree in related field.
• Knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Qualifications

Preferred Qualifications:

• Bachelor’s degree.
• Continuing education such as ACRP, SoCRA or the Graham School Clinical Trials.
• Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, and multi-site trials).