10/14/2021
Job description
Clinical Research Coordinator Job Description
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI) on multiple ongoing research studies. While the Principal Investigator is ultimately responsible for the clinical trial, the CRC is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study. The CRC works collaboratively with the entire RVC team, sponsors, and monitors to ensure productivity and timely completion of studies.
Essential Functions:
Utilizing Good Clinical Practice, the CRC ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP):
• Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities
• Develops accurate source materials and ensures compliance from site staff
• Provides accurate and timely data collection, documentation, entry, and reporting in both sponsor and RVC databases
• Ensures appropriate credentialing and training of the entire RVC team
• Maintenance of regulatory documents in accordance with RVC SOP and applicable regulations
• Interfaces with research participants to support efforts to determine eligibility and consenting of study participants according to protocol
• Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants
• Ensures compliance with research protocols by providing ongoing quality control audits, including maintaining ongoing investigational drug accountability
• Disburses investigational drug and provides patient teaching regarding administration, as necessary. Communicates and collaborates w/ study team, including internal and external parties, sponsors, PI, and study participants.
Other:
• Participate w/ PI and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance
• Occasional travel to attend sponsor study training meetings (required)
• No supervisory responsibilities
• Other duties as assigned
• CPR-certification required
Qualifications:
• Candidates with a Bachelor’s degree in a scientific, health related, or business administration program, preferred. At minimum, a candidate must have a Bachelor’s degree.
• At minimum, candidates must have at least two years of experience as a Clinical Research Coordinator. Preferred candidates will have three or more years as a Clinical Research Coordinator (certification as a CCRC is desired). Ophthalmology background is preferred. Pay will be determined based on experience.
• Knowledge of medical terminology, clinical medicine, clinical trials and GCP concepts
• Detail-oriented and meticulous in all aspects of work
• Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
• Must have professional demeanor and strong communication skills with the public as well as physicians/researchers
• Ability to work well independently as well as in team environment
• Strong interpersonal, customer service, and multi-tasking skills are critical
• Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or have a willingness to learn and demonstrate proficiency within six months of hire
• Ability to be flexible, organized, detail-oriented and tenacious in follow-through
• Possess the ability to work well under pressure, multi-task and manage deadlines
• Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures
Physical Requirements
• Physical Requirement - Feeling (sensing textures and temperatures) (Frequently)
• Physical Requirement - Fine Motor Skills (pinching, gripping, etc.) (Frequently)
• Physical Requirement - Hearing (Frequently)
• Physical Requirement - Pushing/pulling (Occasionally)
• Physical Requirement - Reaching (Occasionally)
• Physical Requirement - Sitting (Frequently)
• Physical Requirement - Standing (Frequently)
• Physical Requirement - Stooping/crouching/kneeling/crawling (Occasionally)
• Physical Requirement - Talking (Frequently)
• Physical Requirement - Tasting/smelling (Occasionally)
• Physical Requirement - Walking (Frequently)
• Physical Requirement - Near Vision (Constantly)
• Physical Requirement - Color Discrimination (Occasionally)
• Physical Requirement - Use of keyboard, mouse and/or computer equipment (Constantly)
• Physical Requirement - Lift up to 35 pounds without assistance (Occasionally)
• Occupational Exposure/Risk Potential - Inside office environment (Applicable)
• Occupational Exposure/Risk Potential - Airbor
