Clinical Research Coordinator 2

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. The CRC2 supports, facilitates and coordinates independently the daily clinical trial activities and plays a critical role in the conduct of the study. 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 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.
• May assist in the training of new or backup coordinators.
• 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 a related field. Work Experience: Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Preferred Qualifications

Education: Bachelor's degree in a related field. Experience: Relevant clinical research experience. Working knowledge of coordinating multiple studies (e.g., investigator-initiated, industry-sponsored, multi-site trials).

Preferred Competencies

• Ability to communicate clearly, professionally, and effectively with patients, faculty, staff, research teams, sponsors, and other stakeholders.
• Strong organizational and time management skills with the ability to manage multiple clinical research activities, prioritize competing demands, and meet established deadlines.
• Ability to establish and maintain effective working relationships with diverse individuals and collaborate across multidisciplinary teams.
• Strong data management skills with demonstrated attention to detail, accuracy, and completeness in maintaining research records and documentation.
• Proficiency in Microsoft Office applications, including Outlook, Word, and Excel, and the ability to learn and utilize clinical research databases and electronic systems.
• Ability to interpret and apply complex clinical research protocols, regulatory requirements, and study documentation while identifying and resolving issues appropriately.
• Ability to exercise sound judgment, take ownership of assigned responsibilities, and complete work accurately and timely with limited supervision.
• Ability to adapt to changing research priorities, study requirements, and work assignments while maintaining productivity and quality.
• Ability to quickly comprehend, retain, and apply new information, including complex study protocols, procedures, and regulatory requirements.
• Ability to understand and adhere to clinical research regulations, institutional policies, study protocols, and confidentiality requirements to support research integrity and participant safety.