Clinical Operations Manager/Clinical Research Coordinator II

Website Institute for Medical Research

The Institute for Medical Research, an affiliate of the Durham VA Health Care System (DVAHCS) is looking for a Clinical Operations Manager/Clinical Research Coordinator II to oversee select clinical research studies conducted by the Principal Investigator, Dr. Stephen Freedland, and his associates in his urology research lab. This includes development of SOPs, preparation of IRB and regulatory paperwork, protocol development including designing CRFs, compilation and documentation of data, and management of projects/personnel. The COM will assist with contract development and study design, as needed.

The COM will be responsible for management of several studies primarily related to urological or oncological diseases such as prostate cancer, bladder cancer, and interstitial cystitis. Studies include prospective observational research, clinical trials, and related tissue and serum-based studies.  This is a supervisory role overseeing Clinical Trials Assistants, who execute day-to-day study operations.

Oversee and coordinate select clinical research performed by the PI:

– Develop, implement, and direct study procedures for each study

– Coordinate with other hospital services such as urology, surgery, and pathology to facilitate research activities

– Oversee Clinical Trials Assistants in identifying eligible patients for studies requiring case and healthy control subjects 

– Oversee Clinical Trials Assistants in recruitment and consent study participants

– Demonstrate good judgment and problem solving to troubleshoot and modify protocol implementation when necessary, including barriers to study recruitment

– Provide input on clinical research projects related to budget, timelines, scheduling, staffing, and other relevant issues

– Coordinate with study sponsors, contractors, other PIs and research team members as part of sponsored or multi-PI studies

– Coordinate with technical team for maintenance, testing, and improvement of research database(s)

Supervise study personnel involved in patient enrollment and data collection including employees, students, residents, and fellows:

– Supervise study personnel, including multiple Clinical Trials Assistants

– Interview, hire, and train new study personnel as needed. Maintain training and delegation logs

– Approve timecards, conduct performance reviews, troubleshoot technical problems, and respond to procedural questions

– Work with the Training and Systems Manager and Clinical Trials – – – Assistants to maintain WOC and VINCI status at the DVAHCS for self and other personnel

Liaise with Regulatory Assistant to maintain all IRB and regulatory paperwork for select clinical research performed by the PI at the DVAHCS:

– Prepare and submit VA-specific protocol, informed consent form, HIPAA authorization, and other related documents for initial review by the IRB

– Prepare and submit amendments, yearly request for continuing approval of open protocols, audits, adverse event reports, and any other IRB-required submissions

– Coordinate with administrative staff to maintain study binder with all IRB related documents and correspondence for each study

– Screen documents and electronic case report forms for completeness and compliance with protocol and appropriate regulations; investigate incomplete, inaccurate, or missing documents to ensure accuracy and completeness of data collected and follow-up with subjects as needed

Oversee organization, collection, and processing of human tissue specimens for select research studies:

– Assist with and train staff on procurement, processing, and shipping of urine, blood, and tissue specimens

– Coordinate with other CRCs to ensure organization of all tissue specimens collected by your staff, including blood, serum, fat, prostate, urine, feces, and lymph nodes

– Facilitate shipping and receipt of specimens to and from external facilities

– Coordinate with other CRCs to ensure specimen processing is executed by staff.  This includes DNA extraction, blood and urine centrifugation, and sample aliquoting

Collaborate with research team, including other CRCs, and work effectively with team members:

– Make decisions about day to day operations related to specific study protocols.

– Make recommendations about program development, employee performance and larger scale operations of the research group

– Coordinate with other CRCs to ensure overall study objectives are met for all clinical research at the DVAHCS

– Update and maintain master staff list, master project list, and SOPs for various tasks

– Participate in conference calls, weekly meetings with leadership, and other team meetings

– Help to prepare for monthly team-wide meetings

Work with IMR Administration to facilitate contracts for select clinical research performed by the PI at the DVAHCS:

– Ensure CRADA and statement of work language is consistent with other regulatory documents including data use agreements, consents, and protocols

– Coordinate with sponsoring group to develop SOPs, obtain CRADA approval, maintain appropriate study documentation and CRFs, and organize site visits

– Assist with budget development, contracts, and invoicing – Track funds and approve invoices

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Skills and Experience:

Education Requirements: Registered Nurse with 2+ years of clinical experience or certified Phlebotomy Technician with 5+ years of experience, or BS in a science field with 3+ years of site-side clinical research experience.

Skill Requirements:

– Experience managing personnel including daily supervision, training, performance reviews, and hiring/firing.

– Experience working in a clinical environment; understands the importance of clinic workflow and able to work diplomatically and professionally with administration, faculty, clinical and lab personnel, and research subjects.

– Demonstrated leadership, professional initiative, teamwork, strong interpersonal relationship skills, decision-making, and good judgment.

– Possess sufficient professional knowledge of clinic operations and general medical research to provide training and guidance to others in the clinic.

– Excellent written and oral skills, Windows, Microsoft Word, Excel, Access, editing, and proper telephone etiquette skills are required for this position.

– Prior experience with clinical research, FDA regulations, and HIPAA considerations is preferred.

– Requires an organized, task oriented, deadline-sensitive individual – Must have the ability to work independently in a fast-paced environment, prioritize and manage the workflow of multiple projects,

– Must be able to occasionally lift at least 40 pounds, sit at a computer for long periods of time, and stand on your feet for long periods of time.

– Has fluency in the English language.

The prior statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Salary range is $58K-$68K annually and will be commensurate with experience level. This position is an exempt salaried role. This position is primarily in-person and candidates must be available to work Monday-Friday.  There may be the option to work remotely up to one day each week as the clinic and recruitment schedules allow.  Expected start date is typically ~6 weeks following job offer and is contingent upon completion and processing of VA paperwork.

IMR offers a competitive benefits package which includes health, dental, vision and life insurance, a matching 403b retirement savings plan, and paid holiday, vacation, and sick leave.  All IMR employees are required to obtain a WOC appointment at the DVAHCS.  As a result, the successful candidate must undergo a federal background check and may be subject to a drug test prior to final hiring. IMR employees must reside in the state of North Carolina; applicants who currently live out of state must be willing to relocate.  We will not sponsor applicants for work visas.

Participation in the seasonal influenza and Coronavirus Disease 2019 (COVID-19) Vaccination programs are requirements for all Department of Veterans Affairs Health Care Workers Without Compensation (WOC). www.imr.org/careers/ to apply Equal Opportunity Employer, including disabled persons and Veterans.

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