Clinical Research Coordinator II

Clinical Research Coordinator II

The Clinical Research Coordinator II (CRC II) is an experienced professional with a solid foundation in clinical trial coordination and execution. Working under the general supervision of a physician and in collaboration with the clinical and research teams in an outpatient setting, the CRC II is responsible for managing all aspects of clinical studies—from study startup through execution and closeout—in compliance with Good Clinical Practice (GCP), ALCOA-C principles, sponsor requirements, and institutional standards (USDP).

As a key member and leader within the research team, the CRC II demonstrates advanced knowledge of clinical research regulatory procedures, and study protocol priorities, while also serving as a role model for professionalism and best practices with research patients and team members. This role requires exceptional organizational skills, the ability to manage multiple high-priority tasks concurrently, and a consistent commitment to high-quality and timely study execution.

Duties and Responsibilities:

• Knowledge and understanding of Federal regulations and guidelines governing protection of human subjects in clinical research (e.g., GCP/ICH, HIPAA regulations, ALCOA Guidelines, OHRP, FDA)
• Maintain all aspects of multiple protocols
• Assist the principal investigator and research manager with site qualification visits, site initiation visits and follow-up monitoring visits for all protocols
• Conduct and coordinate patient visits including patient demography, vitals, EKG, phlebotomy, photography, administering investigational drug, assisting PI and sub-investigators with physical exam, and scheduling appropriate follow-up visits
• Educate patients on study-specific protocol requirements, procedures, side effects and risks of trials and investigative medications
• Communicate frequently with contract research organizations, IRB, Sponsors, Central Lab Facilities, and other outside vendors to manage the day-to-day needs for current and prospective trials
• Maintain and/or create source documents and investigational drug accountability records
• Enter source data into EDC efficiently and accurately
• Review EDC for accuracy and completion, and resolve queries as they arise
• Maintain regulatory documents relates to the ISF
• Follow SOPs, policies, and procedures as set forth by the company
• Assists with direct patient care procedures including biopsies, surgeries, cosmetic procedures and related tasks as related to research protocols
• Process prescriptions and prior authorizations as directed by physician. Address patient and/or pharmacy questions concerning medication
• Enroll patients in patient education/assistance programs
• Ensure necessary study related documentation and correspondence study subjects, study teams, vendors, and sponsors are completed within the timelines set for by the sponsor and USDP SOPs
• Prepare necessary documentation for and lead SIV, IMV, COVs and other sponsor related meetings
• Practices safety, environmental, and/or infection control methods
• Performs miscellaneous job-related duties as assigned
• Process blood and urine samples in accordance with IATA and OSHA standards
• Assist clinical research manager in delegated tasks
• Assist with strategies to maintain recruitment and retention rates and evaluate processes to identify issues related to recruitment and retention rates
• Work with, and delegate tasks to CRAs and CRCs as assigned by the research manager to ensure efficient completion of study related tasks
• Responsible for routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
• Possess in-depth knowledge of all current/active protocols
• Performs other duties that may be necessary or in the best interest of the organization

QualificationsExperience Requirements:

• 3 years of experience in clinical research, required
• 1 year of direct patient experience, required
• 1 year in Dermatology related research, strongly preferred

Knowledge, Skills and Abilities Requirements:

• Detail oriented, professional attitude, reliable
• Organizational skills to support accurate record-keeping
• Ability to follow verbal & written instructions
• Interpersonal skills to work as a team with patients and outside parties
• Able to communicate effectively in English, both verbally and in writing, with proper grammar and spelling skills to avoid mistakes or misinterpretations
• Mathematical and analytical ability for basic to intermediate problem solving
• Intermediate computer operation
• Proficiency with Microsoft Excel, Word, and Outlook
• Specialty knowledge of systems relating to job function
• Familiarity with Phase 1-4 Trials is strongly preferred
• Experience in EDC systems
• Knowledge of regulatory documentation, IRB submissions, modifications, and closeout
• Experience with sponsor related visits (e.g., SIV, IMV, COV)
• Understanding of source documentation, data entry, and ISF
• Knowledge of state and federal regulations such as ICH GCP, IATA; general understanding of HIPAA guidelines
• Previous phlebotomy and clinical lab related procedures is preferred

Supervisory Responsibilities:

This position has no supervisory responsibilities.