$105,000–$117,000 Per Year
Adverse Events, Case Report Form (CRF), Clinical Practices/Protocols, Clinical Research, Clinical Trial, Clinical Trial Management, Computer Software, Customer/Client Research, Data Collection, Data Management, Electrical Components, Emergency Response, Establish Priorities, File Maintenance, Informed Consent, Insurance, Interpersonal Skills, Laptop PC, Lift/Move 20 Pounds, Nursing Credentials, Office Equipment, Ophthalmology, Outsourcing, Physical Demands, Project Planning, Project/Program Coordination, Regulatory Requirements, Research Protocols, Software Development, Staff Training, Standards of Care, Team Player, Time Management, Willing to Travel
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.