Clinical Research Coordinator II (103644)

Job Summary:

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 CRC Is 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.

Experience 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.