East Lansing, MI Job Details Full-time 19 hours ago Benefits On-the-job training Qualifications Electronic health records (EHR) management HIPAA Schedule management ICH guidelines Health information regulatory compliance Productivity software Clinical quality assurance standards Clinical confidentiality policies FDA regulations Full Job Description At L.O. Eye Care, we know that exceptional patient care starts with creating an incredible workplace! We're proud to be known for our outstanding customer service, but we also recognize that it's our amazing team that makes it all possible. That's why we are dedicated to building a work environment that celebrates commitment, rewards performance, and offers personal fulfillment for both our physicians and staff. We are excited to announce an opportunity to join our team as a full-time Clinical Research Coordinator at our East Lansing location! If you're someone who thrives in a collaborative environment, demonstrates leadership, has strong organizational and time-management skills, and radiates positivity and reliability, we want to hear from you. We also offer on-the-job training to help you grow and succeed in this rewarding role! Summary The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and management of clinical research studies conducted within the ophthalmology practice. Working under the direction of the Principal Investigator (PI), the CRC ensures that all research activities are conducted in compliance with federal regulations, Good Clinical Practice (GCP), Institutional Review Board (IRB) requirements, sponsor protocols, and practice policies. Essential Duties and Responsibilities Study Coordinato r Coordinate all aspects of clinical research studies from start-up through close-out. Screen, recruit, and enroll eligible study participants according to protocol criteria. Schedule and coordinate participant visits. Obtain informed consent while ensuring patient understanding of study participation. Perform protocol-specific study procedures within scope of practice. Collect, process, and ship laboratory specimens as required. Coordinate with sponsors, Contract Research Organizations (CROs), and study monitors. Regulatory Compliance Maintain compliance with FDA regulations, ICH-GCP guidelines, HIPAA, and IRB requirements. Prepare and maintain regulatory binders and essential study documents. Submit protocol amendments, continuing reviews, adverse events, and reportable events to the IRB. Ensure accurate documentation of all research activities. Prepare for sponsor audits and regulatory inspections. Data Management Accurately collect and enter study data into electronic data capture (EDC) systems. Maintain complete and accurate source documentation. Resolve data queries in a timely manner. Ensure confidentiality and integrity of patient information. Patient Care Educate participants regarding study expectations, medications, procedures, and follow-up requirements. Monitor participants for adverse events and communicate concerns to the Principal Investigator. Maintain frequent communication with study participants to promote compliance and retention. Coordinator referrals and follow-up appointments as needed. Financial & Administrative Responsibilities Track study milestones and visit completion. Assist with study budgeting and research billing documentation. Maintain research supply inventory. Coordinate study start-up activities, including sponsor feasibility assessments and site initiation visits. Assist with contract implementation and study close-out activities. Collaboration Serve as the primary liaison between investigators, sponsors, CROs, study participants, and practice staff. Work collaboratively with physicians, technicians, scribes, billing staff, and administrators. Participate in investigator meetings and sponsor training sessions. Assist with developing standard operating procedures (SOPs) for the research department. Required Minimum of two (2) years of clinical research coordination experience preferred. Knowledge of FDA regulations, ICH-GCP, HIPAA, and human subject protection requirements. Excellent organizational and time management skills. Strong written and verbal communication skills. Ability to manage multiple studies simultaneously. Proficiency in Microsoft Office and electronic medical record systems. Ability to maintain confidentiality and professionalism. Preferred Previous ophthalmology or ophthalmic clinical research experience. Experience with electronic data capture (EDC) systems. Phlebotomy or clinical certification, if applicable. Physical Requirements Ability to sit, stand, and walk for extended periods. Ability to lift up to 25 pounds. Manual dexterity sufficient to perform clinical procedures and computer work. Ability to travel occasionally for investigator meetings or sponsor training. Competencies Exceptional attention to detail. Strong critical thinking and problem-solving skills. Excellent interpersonal and patient communication abilities. Ability to work independently and collaboratively Strong ethical standards and commitment to research integrity Adaptability in a fast-paced clinical environment. Superior organizational and documentation skills. Performance EEO Statement It is the policy of L.O. Eye Care and its affiliates to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information, or any other protected characteristic under applicable law. This policy relates to all phases of employment, including, but not limited to, recruiting, employment, placement, promotion, transfer, demotion, reduction of workforce and termination, rates of pay or other forms of compensation, selection for training, the use of all facilities, and participation in all company-sponsored employee activities. Provisions in applicable laws providing for bona fide occupational qualifications, business necessity or age limitations will be adhered to by the company where appropriate if applicable.
