Clinical Research Coordinator 2, Department of Surgery

Clinical Research Coordinator 2

The Clinical Research Coordinator 2 (CRC2) is a specialized researcher working with the Principal Investigator (PI), Co-Investigator(s) and other study personnel. Under limited direction of departmental leadership, the CRC2 supports and provides guidance on the administration of the compliance, financial and other related aspects of the clinical study.

Responsibilities

• Manages multiple moderately complex clinical trials that may include national level and multi-institutional pharmaceutical.
• Responsibilities include, but are not limited to, recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring 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.
• Collects, processes, ships, and stores specimens to appropriate laboratory 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. Responsibilities include, but are not limited to, provides efficient and complete data collection, processing, analysis and reporting; assures source documentation and data abstraction and entry are being done at the protocol specified time-points; ensures data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and, 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.

Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.

Work Experience:

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Certifications:

Preferred Qualifications

Education:

• Bachelor's degree.
• Continuing education such as ACRP, SoCRA or the Graham School Clinical Trials.

Experience:

• Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, and multi-site trials).

Licenses and Certifications:

• Management & Regulatory Compliance certification.

Preferred Competencies

• Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines.
• Demonstrated ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.
• Strong data management skills and attention to detail.
• Ability to participate in protocol review and clinical trials evaluations.
• Knowledge of medical terminology/environment.
• Ability to handle competing demands with diplomacy and enthusiasm.
• Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat.
• Familiarity with Good Clinical Practices (GCP).
• Ability to read and understand clinical trials protocols.
• Understanding of the IRB submission and review process and when and how to apply for IRB review.
• Understanding of the federal research regulations and the ability to identify the federal research organizations' role in regulating human research participation.

Application Documents

• Resume (required)
• Cover Letter (required)

When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.