Sunrise, FL
We are looking for a Clinical Research Associate to assist us in conducting clinical trials in the neurology/interventional neurology/neuroradiology/neurosurgery fields. The medical device field is strongly preferred. Candidates must be based in the South Florida area.
The position is mostly remote, with only one weekly office visit to the Broward office.
CRA Certification required.
Clinical trial management platforms: E-Capture, I-MedNet, Metadata
20 - 40% travel depending on which stages they are in for the trial.
Duties and experience required: clinical trial data documentation, consent forms review, negotiating sites and budgets, in-house data monitoring. Knowledge of FDA regulations and reports, SAE Reporting, working with CROs, collecting data. Study start-up activities, general compliance with SOPs....data analysis, and statistical analysis are a plus
Responsibilities:
? Assist with the development and implementation of clinical processes, procedures, and programs.
? Ensure compliance with SOPs, local regulations, and ICH and GCP guidelines.
? Maintain current clinical study SOPs.
? Assist in the clinical conduct and administration of clinical trials.
? Training site staff on protocol requirements, proper source documentation, case report form completion, and electronic data capture platforms.
? Conduct regular site visits (initiation, monitoring, closeout), coordinate project meetings, and writing visit reports.
? Establish and maintain strong relationships and communication with site investigators and research staff.
? Drive subjects’ enrollment.
? Basic data management and analyses.
? Other tasks and responsibilities as needed.
Requirements:
? Bachelor’s Degree in Life Sciences (Biology, Biotechnology, Biomedical Engineering or similar).
? Experience in Clinical Trials, GCP, Institutional Regulatory Boards.
? CRA-certified.
? Ability to travel within the US frequently and ability to manage travel schedules and arrangements.
? Ability to work independently and efficiently; meet all deadlines.
? Knowledge of FDA regulations and their practical implementation.
? Strong verbal and written communication skills.
? Proficient computer skills, especially Microsoft Office (Word, Excel, and PowerPoint), electronic data capture platforms.