Clinical Research Monitoring (CRA)

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.
Perform site qualification, initiation, interim monitoring, and close-out visits per study-specific plans/requirements.
Review for regulatory and protocol compliance.
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.
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.
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., 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.
Maintain a working knowledge of ICH/GCP Guidelines, medical terminology, and relevant FDA regulations.
Bachelor’s degree or equivalent job experience, preferably in a life science, nursing, or related discipline required.
Minimum of two years onsite monitoring experience or applicable clinical research experience.

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.
Effective verbal and written communication skills required to interact with clinicians, clients, vendors, FDA Inspectors, and internal project team members through demonstration of:
Respecting the diversity of our work force in actions, words, and deeds.
Office setting / remote home office. iuvo Clinical fosters a video-first environment; Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Remote; TRAVEL
Up to 75% travel