Ophthalmology and General Medicine - Clinical Research Associate II

Title: Ophthalmology & Gen Meds - CRA II

Location: Remote United States

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Job Description:

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
• 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; 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, 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

The Important Thing for Us

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 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

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): $105-117K

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.