Clinical Research Operations Manager

• Facilitate the training and career development of clinical trial study coordinators, assistants, and nurses; Complete performance evaluations for the team; Communicate job descriptions, performance standards, and expectations
• Manage the efforts of the team and assign/train team members on required job duties.
• Recommend personnel actions including but not limited to hiring, performance management, promotions, and disciplinary actions.

• Portfolio Management: Ensure executive planning, oversight, and coordination of clinical research projects, Manage and direct efforts of a designated group of study coordinators and research assistants, Ensure effective coordination of resources and across study coordinators, Monitor the progress and performance of all projects to include enrollment and services, Coordinate regular clinical trial employee meetings to review ongoing projects, potential projects, enrollments, challenges, Identify operational problems, barriers, obstacles, and issues across all clinical trials based on input from PIs, study coordinators, and research assistants, Provide data to leadership to support strategic planning efforts
• Coordination: work independently and with the research team on all study requirements to ensure the study is conducted according to the protocol, federal regulations, and institutional guidelines. Additionally, this position will develop materials, execute procedures, and monitor research activities in conjunction with the sponsor/research team.
• Regulatory: assist with regulatory and study documentation, such as preparing Institutional Review Board applications, consent forms, patient binders, annual reports, and training guides and SOPs. Prepare all protocol-required materials in order to successfully complete the study. This position will also be responsible for assisting with monitoring visits and audits.
• Recruitment: screen patients for eligibility, consent / enroll subjects into studies, and monitor enrollment goals.
• Data Management: collect data from patients and medical records, recording study data as prescribed by study protocol, exhibiting the highest ethics with regard to data collection, maintaining patient enrollment logs and files, analysis of data to determine the eligibility of patients to enroll and participate in the study, use of online programs to record data, host site visits by study sponsor. Complete Adverse Event Reports as required by the study protocol. Work with the research investigators to resolve queries as needed.
• Patient education, including informed consent, education about study participation and the expectations of participants (federal regulations, safety precautions), education about study protocol including risks involved, telephone follow-up with patients, following OSHA and HIPAA guidelines in all situations, providing communicative access to study families for questions pertaining to the study.
• Other operational tasks as required.

• Ensure procedures required by study protocol, such as laboratory tests, EKGs, echoes, x-rays, bone density, etc. are performed and documented correctly.
• Guarantee that study-related procedures are performed within timelines outlined in the protocol or study plan.
• Collect, process, and ship biospecimens.
• Other clinical duties as required.

• Maintains documentation of enrollments, tracks metrics, and outcomes, and produces related reports as requested. Consult and collaborate with clinical research leadership to ensure studies remain on track for target enrollment and closure.
• Demonstrates a customer-focused style of communication, problem-solving, and collaboration
• Coordinates with internal functional departments to ensure various research activities are aligned with protocol and clinical flows, and that mutually agreed-upon timelines are met.
• Conducts process improvement through evaluation of workflows, development of documentation, and communication with key stakeholders.
• Direct and frequent communication with principal investigators and other clinical staff
• Must work as a part of a team. It is essential that this position establishes and consistently maintains a positive relationship with study participants, investigators, clinicians, coworkers, and related personnel. This position may act as a liaison between institutional investigators, industry sponsors, reference laboratories, federal supervising agencies (NIH and FDA), and institutional personnel.
• This position will require direct communication with collaborating researchers, technicians, data coordinators, and clinical and clerical personnel within the University and health system.
• This position also involves direct communication with patients (and potentially legal guardians) to see that they understand the purpose of the study and its risks and benefits.
• Attends and leads team meetings, prepares reports, and communicates additional information around study activities as needed.

• Support pre-award research funding (Initial budget review and draft negotiations) & post-award research funding (submit invoices),
• Provide input to the financial team to ensure in order to effectively project financial models,
• Participate in meetings with the financial team and leadership to ensure all trial expenses are accurately and appropriately recorded in a timely manner
• Assist with financial reconciliation, invoicing, and budgeting including but not limited to Medicare coverage analysis, clinical trials participants list, and billing compliance.
• Communicate regularly with research financial analysts when research procedures are conducted.

If you experience any problems accessing the system or have questions about the application process, please contact the Department for People Operations, Success, and Opportunity at (252) 328-9847 or toll free at 1-866-489-1740 or send an email to employment@ecu.edu. Our office is available to provide assistance Monday-Friday from 8:00-5:00 EST.