Ophthalmology & Gen Meds - CRA I/II & Sr. CRA

About this role

We are currently seeking Experienced Ophthalmology (Sr CRAs & CRA 1/2) & Gen Med CRA 1/2s 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 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 repo11s, narratives and follow up of  SAEs • Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management • Assist with training of new employees, eg. 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

The important thing for us is you are comfortable working in an environment that is: • Fast paced : where no deviations from the study protocol are allowed, and not meeting a timeline for even 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.

What do you get?

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to: • 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): $105-140K

Work 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.

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 moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. • Regular and consistent attendance. • Varied hours may be required.

#LI - Remote Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here .

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