Ophthalmology & Gen Meds - CRA II

We are currently seeking Experienced Ophthalmology & Gen Med CRA 2s to lead and support our Full Service Outsourcing team. Open to major hub locations on the East & West Coast. 60-70% travel, 8-10 DOS per month. What You Will Do You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards. Responsibilities Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties as assigned. Responsible for all aspects of site management as prescribed in the project plans. General On-Site Monitoring. Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study. Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document monitoring, and monitor data for missing or implausible data. Responsible for all aspects of registry management as prescribed in the project plans; undertake feasibility work when requested. Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. Independently perform CRF review; create queries and resolve against established data review guidelines on Fortrea or client data management systems as assigned by management. Assist with training of new employees, e.g., co-monitoring. Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned. Perform other duties as assigned by management. Requirements University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). 1-3 years of Clinical Monitoring experience. Open to various hub locations. Work Environment Fast paced: no deviations from the study protocol are allowed, and not meeting a timeline even for a few minutes will create a quality issue. Changing priorities constantly, asking you to prioritize and adapt on the spot. Teamwork and people skills are essential for the study to run smoothly. Technology based. We collect our data directly into an electronic environment. Work is performed in an office environment with exposure to electrical office equipment. Frequent travel to clients/site locations with occasional travel both domestic and international. Remote. Physical Requirements Ability to sit for extended periods and operate a vehicle safely. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Light to moderate lifting and carrying (or otherwise moving) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Regular and consistent attendance. Varied hours may be required. Benefits Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers). 401(K). Paid time off (PTO) – Flex Plan. Employee recognition awards. Multiple ERG’s (employee resource groups). Target Pay Range (based on title): $105-117K. Learn more about our EEO & Accommodations request here. #J-18808-Ljbffr