FSP Sr. Clinical Research Associate - Florida
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FSP Sr. Clinical Research Associate - Florida
We are currently seeking Experienced Sr. CRAs with 5+ years of monitoring experience to lead and support our FSP team! We are open to experienced CRAs in Florida or the South East US.
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 data review.
- 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).
- 5+ years of Clinical Monitoring experience.
- Open to major hub locations in the South East US.
The environment is fast-paced, constantly changing priorities, teamwork and people skills are essential, and data collection is technology-based.
What do you get?
Benefits
Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including:
- Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers).
- 401(K).
- Paid time off (PTO) – Flex Plan.
- Employee recognition awards.
- Multiple ERGs (employee resource groups).
- Target Pay Range (based on title): $125-140K.
This position is remote. Applications are accepted on an ongoing basis.
Learn more about our EEO & Accommodations request here.
Additional Details
- Seniority level: Mid-Senior level
- Employment type: Full-time
- Job function: Research, Analyst, and Information Technology
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