Clinical Research Associate/Clinical Trial Manager (Medical Device)

We are a medical technology company in South Florida that is revolutionizing heart-failure care with our patented non-invasive technology. With a mission to make high-value cardiac assessment, accessible and affordable. Won prestigious accolades such as, Florida Company to Watch, DARPA success story company, Defense Innovation Awards, Good Design Award and backed by the National Heart, Lung, and Blood Institute. We are fast-paced and growing and we are prepared to offer a competitive compensation package, stock options, health insurance, company matched retirement plan, wellness perks, unlimited vacation time, and so much more!

We are seeking a strong, experienced Clinical Research Associate/Clinical Trial Manager, with experience in clinical research environment for monitoring duties, managing various projects, expanding the business, skills in medical and technical literature review, collection of research data and preparing reports, studies conduct and management.

Responsibilities

• Manages people managers; recruits, hires, mentors, and manages direct reports as required and supports their professional development.
• Responsible for managing aspects of planning, implementation and the operation of multisite trials.
• Strong collaboration and partnership with cross functional colleagues (Clinical Development, Project Management, Regulatory, Medical Affairs, Engineering) to ensure on-budget, timely, high quality delivery of the programs.
• Maintain project and study-related documents; including informed consent forms, clinical trials outlines, monitoring plans, synopses of protocol, IRB study protocols, protocol amendments, and clinical summaries
• Travels nationally as required.
• Track protocol and consent changes; submit and maintain IRB approval and regulatory documentation.
• Coordinate and conduct training of study personnel on study protocol and study manuals with external research site visits, procedure scheduling and monitoring and support of clinical sites.
• Leads the conduct of scientific research to assimilate data into written deliverable products for clients such as protocols, clinical study reports, briefing documents, abstracts, papers, training materials, and written summaries
• Coordinate Data and Safety Monitoring Board (DSMB) meetings.
• Active participation and leadership in clinical operations and cross-functional organizational initiatives to drive improvements in efficiency, operational excellence and revenue.
• Work closely with and develop strong physician/customer relationships, to ensure patient recruitment milestones are met.
• Clinical operations oversight, including tracking and managing deliverables and working cross-functionally with key stakeholders to optimize processes as related to early phase studies in efforts to streamline timelines without compromising quality data deliverables.
• Periodic analysis of data and reporting to management and regulatory representatives.
• Assist with FDA submissions and tracking of documents.
• Initiates continuous efforts in identifying and applying best practices and enforcing standardization among teams and across programs.
• Member of the leadership team, responsible for effective oversight of designated personnel and programs, as well as driving department goals with initiatives to increase revenue.
• Leads teams in areas of Clinical, Scientific, Regulatory and Medical Writing projects; provides guidance and editorial review of documents as needed to meet specifications and regulatory requirements

Qualifications and education requirements

• Open to full-time applicants only.
• Line management experience. Typically has multiple years’ experience managing other people leaders (with indirect reports).
• Ideally 5+ years of experience in clinical operations and a BS/BA or higher degree in a relevant scientific discipline. MS/MA or higher will need 3+ yrs experience in clinical operations.
• Experience on governance committees and management teams for CROs or other vendors.
• The job is in-person at the Boca Raton office, remote work as necessary.
• Understanding of Good Clinical Practices, Quality System/ISO regulations and SOPs.
• A US citizen or permanent resident is preferred. Others can apply as we will sponsor H1B visas.
• Excellent written and oral communication skills to support interaction with team members, internal management and contributing to the engineering design documentation system.
• Ability to work in a fast paced / dynamic team environment and possess time management skills to meet schedules.
• CCRA certified by the Association of Clinical Research Professionals is preferred but not required.
• Prior medical device clinical trials/operations experience in company sponsored clinical trials.

Other Requirements

• Proven ability to influence up, down and across the organization and externally in a collaborative manner.
• Strong communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution. Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans and strategic objectives.
• Exceptional interpersonal skills and understanding of team dynamics.
• Advanced coaching capabilities to mentor/develop staff.
• Understanding of regulatory requirements and impact on development and execution of clinical trials.
• Knowledge of medical devices and/or biotech industry
• Strong negotiation and conflict resolution skills.
• Thorough knowledge of Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools.
• Strong executive presence with demonstrated influence through leadership both on program teams and organizational initiatives.
• Strong track record in effectively conceiving and leading complex initiatives.

Job Type

• Full-time
• Only open to candidates in Florida, who can commute to work location in Boca Raton, FL.
• One location (Boca Raton, FL) and no relocation will be provided.

What's in it for you

• Un-limited PTO/VACATION!
• Strong base salary!
• Amazing company culture!
• Child care reimbursement!
• Gym reimbursement!
• SIMPLE IRA (with matching!)
• Stock!
• Huge room for growth!
• Opportunity to drive successful teams within an exciting industry!
• Healthcare benefits!
• Annual bonus!