Description
We are currently seeking Experienced Ophthalmology (Sr CRAs & CRA 1/2) to lead and support our Full Service Outsourcing team. Open to major hub locations within the United States. 60-70% travel, 8-10 DOS per month.
You will utilise 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 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
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