Clinical Research Coordinator

Benefits

Qualifications

• •Must be comfortable working in low-light exam environments and possess full spectrum visual acuity (corrected or uncorrected)
• •Certified Clinical Research Coordinator (CCRC) or willingness to obtain certification encouraged
• •Familiarity with clinical trial regulations (FDA, ICH-GCP) required
• •Strong interpersonal, multitasking, and documentation skills
• •Proficiency with EDC platforms and Microsoft Office Suite
• •Ability to Commute:
• •Johnson City, TN 37604 (Required)
• •4 more items(s)

Responsibilities

• •Maintain a thorough understanding of each assigned clinical trial protocol, including objectives, endpoints, and regulatory context
• •Coordinate informed consent processes per GCP guidelines, ensuring patient comprehension and appropriate documentation
• •Monitor regulatory documents (e.g., Form 1572, delegation logs) for accuracy and completeness before study initiation
• •Provides guidance to ancillary staff (e.g., photographers, OCT techs, BCVA-certified personnel, front office, masked/unmasked staff) to ensure protocol adherence and timely task execution
• •Communicates with them proactively throughout the study
• •Collaborate with the Screening Department to develop and process screening packets within enrollment timelines
• •Screen, enroll, and retain eligible patients in assigned studies while monitoring for protocol compliance and safety signals
• •Educate subjects about protocol changes, risks, and updated informed consent forms
• •Maintain accurate, timely source documentation and electronic CRFs per protocol and SOPs
• •Conduct chart reviews and patient outreach to boost study recruitment; respond to internal and external referrals within 24 hours
• •Communicate proactively with sponsors, CROs, and monitors (CRAs, medical monitors) to resolve queries and complete action items
• •Transport or coordinate pick-up of biological specimens as required by protocol
• •Participate in study monitoring visits and audits with professionalism and accuracy
• •Cross-cover for other research coordinators and assist with telephone screening as needed
• •Maintain awareness of and compliance with FDA, ICH-GCP, and institutional regulatory standards for clinical research
• •Travel between SERA locations if needed and work overtime when necessary
• •Perform additional duties as assigned to support the research team and overall patient care mission
• •Physical & Cognitive Demands
• •Frequent walking and standing throughout the day to assist patients and support physician activities
• •Able to lift/move items >15 lbs (e.g., supplies, specimens)
• •Frequent use of hands for fine motor tasks, such as operating equipment and documentation
• •Comfortable guiding and physically supporting patients with low vision
• •Verbal communication skills to support patient education and coordination with clinical teams, sponsors, and study staff
• •Occasional stooping, kneeling, or crouching in exam and procedure rooms
• •Ability to sustain attention to detail, maintain data integrity, and document precisely in a fast-paced environment
• •22 more items(s)