Innovo Research · 3 weeks ago
Senior Clinical Research Coordinator
Wilmington Health - Wilmington, NC 28401
Full-time
Onsite
Mid, Senior Level
3+ years expInnovo Research is seeking a Senior Clinical Research Coordinator to work closely with Principal Investigators and clinical research teams. The role involves coordinating daily operations of clinical research studies and overseeing clinical research staff to ensure compliance with regulations and efficient execution of research activities.
Hospital & Health Care
No H1B
Responsibilities
Assist with mentoring and training clinical research staff
Perform clinical functions i.e. phlebotomy, monitoring vital signs on study participants, etc., when warranted; educate family and contribute to the care and evaluation of subjects, including determining preliminary inclusion/ exclusion criteria
Liaises with agencies, pharmaceutical companies, laboratories, vendors, equipment, and supply companies as needed; oversees availability of supplies and/or equipment for studies
Manage multiple concurrent trials - screening, recruiting, and enrollment, perform patient/research participant scheduling, coordinate protocol-related research procedures, study visits, and follow—up, collect patient/ research participant history, collect and maintain source documentation, perform data entry and query resolution, prepare IRB submissions, update required modifications, continuing reviews, and reportable events
Develop strong working relationships and maintain effective communication with study team members
Completes all protocol-related training and adheres to IRB approved protocol(s)
Support the collection and review of required essential study documents and reports
Order supportive study supplies (e.g., contracts, IXRS, lab kits, non-clinical supply materials, imaging, and laboratory handling manuals, etc.)
Assist in the informed consent process of research subjects
Support and advocate for the safety of research subjects
Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close-out activities
Collect, process, and ship laboratory specimens
Comply with Innovo, Clinic, and Sponsor policies, standard operating procedures (SOPs), applicable regulatory requirements and guidelines
Performs all additional duties as assigned
Qualification
Required
At least 3-5 years of experience coordinating clinical trials, including the activities listed above
BS/BA in Life Science or related discipline
Previous GCP training and certification required and working knowledge of current ICH GCP guidelines and applicable regulations
Experience in a clinical setting
Demonstrated ability in positive relationship building
Strong interpersonal skills with attention to detail a must
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems
Strong organization/prioritization skills for the management of multiple concurrent projects
An understanding of Regulatory and Central/Local ethic submission processes
Ability to manage multiple competing priorities within various clinical trials
Excellent verbal and written communication skills required
Ability to work independently, prioritize, and work with a matrix team environment is essential
Ability to travel for Clinic activities, and attend investigator meetings or vendor visits/audits, as required
Preferred
Certified Clinical Research Coordinator (CCRC) certification preferred
Previous experience with training and mentoring other clinical research professionals is a plus
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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