We are looking for a seasoned Clinical Research Coordinator who is interested in jumping into an exciting opportunity with a growing team that is an integral part of a large national network of sites. This role will be based remotely on either the West or East coast and will require up to 70 percent weekly travel to various sites to work as a Study Coordinator.

Candidates who will be successful in this role will be adept at all aspects of the clinical trial life cycle, will be able to see patients, manage multiple studies at one time, pivot without issue, work with various personality types and have a team focused and positive attitude with a passion for research.

Weekend travel is not anticipated, all travel costs are covered along with a daily meal per diem and candidates must live within a half hour of a major US airport.

Must haves

• Bachelor’s Degree and/or 3 years’ experience as a clinical research coordinator with industry experience
• Ophthalmology experience preferred
• CCRC Preferred
• Bilingual Preferred

Responsibilities

• Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study
• Ensures study staff is properly trained on study-related information (i.e., protocol, ICF, manuals, etc.) and that the training is documented
• Attends teleconferences and Investigator Meetings as requested by research director
• Reviews and comprehends all study protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections
• Collects updated medical history, adverse events and serious adverse events that need to be reported to the sponsor and IRB within required time frame
• Assures that amended consent forms are appropriately implemented and signed
• Acts as a secondary reviewer to provide oversight so that the ICF process is conducted accurately
• Collects data as required by the protocol and enters information into the electronic data capture (EDC) system in the specified time frame indicated in the study contract.
• Oversees data and ensures that it is being entered correctly and resolves any queries issued within required time frame
• Responsible for ensuring all SUSAR/Safety Reports are acknowledged and reviewed
• Coordinates monitor site visits and assists with preparation of site visit documentation
• Works with the monitor to make any corrections needed to meet requirements and deadlines as needed
• Manages and maintains all regulatory information about the study including the protocol, investigator brochure, IRB documents, Investigator disclosures, CVs, training documentation, instructions on reporting requirements for the IRB and the sponsor