Remote Ophthalmology Clinical Research Associate & Monitor

Clinical Research Associate job at IUVO BIOSCIENCE OPERATIONS, LLC. Rochester, NY. A Trusted CRO Partner for the Future of Eye Care iuvo Clinical is a full-service ophthalmology-focused contract research organization (CRO) dedicated to improving patient’s quality of life with breakthrough eye care therapies. We combine decades of specialized experience with a high touch, high science approach, partnering with innovators to accelerate ophthalmic breakthroughs from concept to commercialization. Whether advancing a novel retinal therapy or supporting a complex ocular device trial, we provide the expertise, flexibility, and personal dedication to ensure your clinical trial’s success. We currently have an exciting opportunity for a Clinical Research Associate to join our team! The Clinical Research Associate (CRA) is responsible for the monitoring of clinical research activities at research sites that are actively conducting clinical trials. ESSENTIAL DUTIES AND RESPONSIBILITIES Perform site qualification, initiation, interim monitoring, and close-out visits per study-specific plans/requirements. Review for regulatory and protocol compliance. Review and verify informed consent forms and informed consent process. Assess PI oversight of study activities. Confirm accuracy and data integrity by reviewing eCRFs/CRFs, site source documents and other sources of study-specific site documents as applicable. Complete timely and comprehensive site visit reports and associated correspondence per the trial-specific Monitoring Plan. Adhere to trial-specific monitoring visit report submission, finalization, and associated correspondence timelines. Identify and report protocol deviations and risks to subject safety/data integrity. Generate queries and work towards query resolution with site personnel. Perform investigational product and/or device, ancillary supplies, and equipment review/accountability as applicable. Evaluate performance of and adherence to study protocol at the site level. Evaluate overall performance of site and site staff, provide recommendations, and escalate issues as needed. Provide initial site training and re-training as needed. Monitor trial participant recruitment activities and progress. Reconcile and facilitate adverse event and serious adverse event reporting and documentation as needed. Review essential regulatory documents and compare them to study TMF to confirm completeness and accuracy. Verify site study supply inventory is adequate as applicable. Participate in the identification and selection of investigators and sites as applicable. Serve as a liaison and resource for Investigators, Institutions, and Sites, providing support during the conduct of the clinical trial. Attend internal and external team calls to stay informed of current study status and provide feedback/updates as needed. Attend internal and external trial-level, line manager/department-level, and company-level meetings as applicable. Provide In-House CRA and Site Start-up and Essential Document Specialist support for assigned sites as needed inclusive of but not limited to: Data line listing review/data cleaning activities prior to data locks, eTMF document workflow processing and maintenance of regulatory trackers. Complete timely entry of data for assigned sites within trial level electronic tracking system as applicable (e.g., CTMS). Data entry/tracking is inclusive of but not limited to: Action Items, Site Visit status, Monitoring Visit Report and site correspondence, and PDs. Maintain timely trial-level calendar updates for monitoring visits, travel, and out of office time, as applicable. Promptly submit time and expense reports within specified electronic system and adhere to trial-level budget requirements. Escalate issues as needed. Maintain a working knowledge of ICH/GCP Guidelines, medical terminology, and relevant FDA regulations. Timely completion, review, and understanding of iuvo SOPs, work instructions and guidelines, and any sponsor-specific requirements. Ability to work across multiple trials as needed. May mentor other internal study-team members. May assist with development of study manuals, plans, CRFs, and other study-specific tools/templates. May present at Investigator and other trial-specific meetings. QUALIFICATION REQUIREMENTS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. EDUCATION and/or EXPERIENCE Bachelor’s degree or equivalent job experience, preferably in a life science, nursing, or related discipline required. Minimum of two years regional monitoring experience or applicable clinical research experience. A diverse understanding of Ophthalmic indications, associated procedures and standards of Ophthalmic practice. Strong working knowledge of GCPs and federal regulations. Current GCP certification required (or willing to obtain). COMPUTER SKILLS Experience working with EDC, eTMF, CTMS and other clinical trial systems is highly preferred. Proficiency with Microsoft Office (Word, Excel, Outlook, Teams) and other software/programs as applicable to position. COMMUNICATION SKILLS Effective verbal and written communication skills required to interact with clinicians, clients, vendors, FDA Inspectors, and internal project team members through demonstration of: Excellent presentation and interpersonal skills, including clear, succinct, and timely communication. Sharing ideas in a constructive and positive manner. Listening to and objectively considering ideas and suggestions. Keeping commitments. Keeping others informed of work progress, timetables, and issues. Addressing problems/issues constructively to find mutually acceptable solutions. Respecting the diversity of our work force in actions, words, and deeds. Read and comprehend work instructions/SOPs and protocols and write clear concise reports. OTHER SKILLS and ABILITIES Must be highly organized, able to efficiently schedule and execute follow-up of tasks, manage multiple priorities, demonstrate strong attention to detail and analytical skills. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to sit or stand at a desk, talk, and hear. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Office setting / remote home office. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. LOCATION Remote; Near major airport TRAVEL Up to 75% travel DISCLAIMER This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice. iuvo Clinical is an Equal Opportunity Employer #J-18808-Ljbffr