Innovo Research · 1 week ago
Clinical Research Manager
Piedmont Healthcare - Statesville, NC 28625
Full-time
Onsite
Mid, Senior Level
3+ years expInnovo Research is dedicated to conducting clinical trials and ensuring high quality in research activities. The Clinical Research Manager oversees the daily operations of clinical trials, ensuring compliance with protocols and regulatory guidelines while managing site staff and resources effectively.
Hospital & Health Care
No H1B
Responsibilities
Develop and implement strategies to achieve site-level performance metrics
Drive research growth by addressing barriers, ensuring compliance, and maintaining quality standards with a sense of urgency
Manage site staff, including timekeeping, performance evaluations, and performance improvement plans; hire, train, and develop new team members with central support
Hold staff accountable for meeting quality, compliance, and performance standards while providing coaching and mentorship
Ensure site staff readiness for research activities, including meeting First Patient Visit (FPV) timelines
Delegate responsibilities, set clear expectations, and provide regular feedback to team members. Support onboarding and career development opportunities for new and existing staff
Foster relationships with investigators and build partnerships with the local medical director
Facilitate integration between clinical research and clinical care and act as the primary contact for the Partner Site
Advocate for site staff and Partner Site needs to support strong study execution and performance
Prepare for and guide staff during FDA audits and sponsor-initiated quality assurance audits in coordination with Central Operations
Oversee the availability of supplies and equipment necessary for research studies
Coordinate pre-study, site qualification, study initiation, monitoring visits, and study close-out activities. Support the collection and review of essential study documents and reports
Provide back-up support, if needed: Conduct or oversee key research activities such as participant screening, recruitment, scheduling, protocol adherence, data collection, and query resolution. Perform clinical functions as needed, including phlebotomy, obtaining vitals, and educating participants and families. Assist in evaluating participants for inclusion/exclusion criteria. Collect, process, and ship laboratory specimens when required
Ensure compliance with Innovo, clinic, and sponsor policies, standard operating procedures (SOPs), and applicable regulatory requirements
Perform additional duties as assigned
Qualification
Required
Minimum 3-5 years of experience coordinating clinical trials, including relevant activities listed above
A Master's degree or previous management experience may substitute for one year of trial coordination experience
Bachelor's degree in Life Sciences or a related discipline, preferred
Certified Clinical Research Coordinator (CCRC) credential required
Strong knowledge of FDA regulations and ICH guidelines
Excellent interpersonal skills with strong attention to detail and a positive attitude
Demonstrated ability to work effectively across all staff levels to coordinate and execute study activities
Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, SharePoint) and clinical trial master filing systems
Strong organizational and prioritization skills for managing multiple concurrent studies
Proficiency in regulatory and central IRB submission processes
Excellent verbal and written communication skills
Ability to work independently and in a matrix team environment
Ability to be on-site, travel for clinic activities, and attend investigator meetings or vendor audits as required
Preferred
Bachelor's degree in Life Sciences or a related discipline, preferred
Preferred experience in training and mentoring clinical research professionals
Benefits
Competitive salary
Health Insurance
Dental Insurance
Disability Insurance
Life Insurance
Paid Time Off
Vision Insurance
Company
Innovo Research
Innovo Research is a provider-sponsored, provider-led network of high-performing Accountable Care Organizations (ACOs) that utilize clinical research as part of their population health strategy.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Cerdi Beltre
Chief Operating Officer
Halley Losekamp
Senior Vice President Strategy and Partnerships
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