Clinical Research Coordinator 1

Job Summary

The Clinical Research Coordinator 1 (CRC1) is a specialized researcher working with the Principal Investigator (PI) and under the direction of the research program manager. While the PI is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC1 supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC1 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

• Coordinate 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.
• Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
• Recruit and interview potential study patients with guidance from PI and manager.
• Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
• 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.
• Protect 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.
• Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
• Participates in study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
• Accountable for all tasks in basic clinical studies.
• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.
• 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 years of work experience in a related job discipline. Certifications: ---

Preferred Qualifications

Education: Bachelor's degree. Experience: Knowledge of medical terminology/environment.

Preferred Competencies

• Ability to communicate with tact and diplomacy.
• Strong organizational skills.
• Strong communication skills (verbal and written).
• Excellent interpersonal skills.
• Strong data management skills and attention to detail.
• Knowledge of Microsoft Word, Excel and Adobe Acrobat.
• Ability to read and understand complex documents (e.g., clinical trial protocols).
• Ability to handle competing demands with diplomacy and enthusiasm.