Clinical Research Operations Manager

Overview

It is the mission of East Carolina University (ECU) Brody School of Medicine (BSOM) and ECU Health to provide exemplary medical education / training for physicians at the undergraduate and graduate levels.

Additionally, it is the mission of BSOM to provide model comprehensive primary and consultative subspecialty care to patients in eastern North Carolina, to advance scientific knowledge through basic, translational, and clinical research, and to provide continuing medical education opportunities for physicians in the region.

The Office of Clinical Research (OCR) will be a newly established central office in BSOM designed to support the management and conduct of clinical research while promoting compliance.

This is accomplished through standardizing the approach to clinical research across the various research centers and departments in BSOM and ECU Health and supporting investigative teams through regulatory and operational assistance, and enhancements in study management and oversight.

Job Duties The Clinical Research Manager will assist with the daily operations of conducting clinical research studies at ECU and ECU Health by working closely with the study sponsors, clinical units, research teams, and the UMCIRB office as well as external IRBs.

This team member will be split to 50% supervision and 50% operational activities, including managing a portfolio of studies.

Managers will support investigators, clinical staff, and patients with the required activities and operations of theirs and their team’s studies.

This team member will assist with development of source documents, patient study records, operation workflows, and oversee the completion of study visits, data entry, and specimen processing.

This position will be responsible for recruitment and tracking of potential research participants, achieving enrollment targets, conducting visits according to protocols, documenting issues with the IRB and other regulatory bodies, effectively communicating to a variety of stakeholders, and other duties as assigned.

This team member will be responsible for leading a team of research coordinators, assistants, and nurses focused on one or more therapeutic areas.

Typically, managers will lead 5 or more studies of their own, while supervising a team of 4-8 research staff that work across a portfolio of 40 80 studies.

Supervision of Personnel 50% :

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.

Assist with Research Preparation, Enrollment, Data Collection & Reporting, including but not limited to 20% :

• 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.

Clinical / Patient Care 15% :

• 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.

Communication and Oversight 10% :

• 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.

Financial Management 5% :

• 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.

Contingent upon availability of funds

Posting is for three vacancies which include positions : , , Minimum Education / Experience Master’s degree in a discipline related to the field assigned;

or Bachelor’s degree in a discipline related to the field assigned and three years of research / analysis; all degrees must be received from appropriately accredited institutions.

License or Certification Required by Statute or Regulation None Preferred Experience, Skills, Training / Education Experience with human subjects research, familiarity with Electronic Medical Records (such as EPIC), experience working on clinical research projects, one year of leading teams or supervising staff, CITI ethics training, or equivalent training by the department.

Special Instructions to Applicant Applicants must be currently authorized to work in the United States on a full-time basis.

At the time of employment two to three original letters of reference, official transcripts, a criminal background check, and proper documentation of identity and employability are required.

Please be aware that if selected for an interview, an automatic e-mail will be sent to the individuals entered by the applicant in the references section of the PeopleAdmin applicant tracking system.

Letters of reference submitted via the PeopleAdmin applicant tracking system will be verified and considered towards meeting this requirement.

Additional Instructions to Applicant In order to be considered for this position, applicants must complete a candidate profile online via the PeopleAdmin system and submit any requested documents.

Additionally, applicants that possess the preferred education and experience must also possess the minimum education / experience, if applicable.

Job Open Date 08 / 08 / Open Until Filled Yes Job Close Date - Positions will be posted until 11 : 59 p.m. EST on this date.

If no closing date is indicated, the position may close at any time after the initial screening date. Initial Screening Begins 08 / 23 / Rank Level