Sr. Clinical Research Startup Specialist

Position Summary

Senior Clinical Research Associate responsible for providing monitoring, support of administration and progress of clinical trials conducted by the medical device company. The Senior Clinical Research Associate shall serve as the leader for the Clinical Research Associate team.

Key Accountabilities:

• Conduct Pre-Study Visits to assess to ensure the facilities are adequate and staff has required qualifications. Review patient population, staff experience with previous studies, FDA audits, current study load, etc.
• Conduct Site Initiation Visits for the purpose of training site personnel about the protocol, study procedures, patient recruitment and retention requirements, regulatory requirements, Case Report Form completion and retention requirements, device accountability, serious adverse event (SAEs), reporting procedures and overall management.
• Conduct Interim Monitoring Visits for verification of the integrity of clinical data with respect to accuracy, accountability, documentation, and methods or procedures through review of CRFs, source documents, medical records, and regulatory documents.
• Conduct Close-Out Visits. In addition to conducting applicable activities as outlined in Interim Monitoring Visits, the CRA will remind the Investigator of his/her responsibility to submit a final report to the IRB, review the record retention requirements, and remind the Investigator and study team members about the possibility of audits/inspections by Bolton Medical, the CRO, and/or FDA.
• Provide feedback to assigned sites, including a summary of overall site functioning and detected deficiencies and corrective action needed; follow-up with sites until deficiencies are resolved.
• Monitor the clinical progress for all assigned sites, in addition to providing site management through frequent contact with the site staff, by telephone and monitoring visits.
• Provide ongoing to clinical trial support to the Clinical Operations Manager and Clinical Project Manager and take on special projects as assigned.
• Lead special projects related to the trial as assigned by management.
• Develop and/or revise procedures related to Clinical Operations as needed.
• Startup Specialist: Provide site start up management and oversight for one or more clinical protocols as assigned.
• Startup Specialist: Ensure successful activation, including completion of Clinical Trial Agreement, Budget, IRB approval and Essential Documents, for all designated sites through frequent contact with the Investigators and study personnel in accordance with the Activation/Start up Plan.
• Startup Specialist: Negotiate Clinical Trial Agreements and Budgets within guidelines established by Study Management.
• Perform other related duties incidental to the work described herein.

Internal Networking/Key relationships:

This position requires cooperating with different company departments, such as Finance, Sales, Marketing, R&D, Logistics, Manufacturing, Engineering and other team members of the department.

Minimum Skills and Capabilities:

• Excellent Written and Verbal Communication
• Ability to interact with all levels within internal and external organizations
• Analytical skills for compiling and analyzing data

Minimum Knowledge & Experience required for the position:

• B.S. in scientific discipline/life sciences preferred
• Three to five years as a Clinical Monitor in a related device or pharmaceutical industry and at least 3 years as a Regional CRA/Monitor, (CRA certification a plus)
• Must have excellent communication, writing, and analytical skills.
• Travel (45-60%) is required for this position, more at times depending on trial status.
• Position may be regionally based, or office based in Sunrise, Florida.
• Good working knowledge of GCPs, FDA Regulations and all monitoring responsibilities
• Ability to manage multiple projects or tasks, to evaluate a variety of unpredictable scenarios, and achieve project timelines while applying an understanding of the study protocol(s).