(Hybrid) Protocol Management Manager - WVU Cancer Institute/Clinical Research Unit

Description

West Virginia University Research Corporation is currently accepting applications for a (Hybrid) Protocol Management Manager with the WVU Cancer Institute / Clinical Research Unit

About the Opportunity

Under the direction of the WVUCI CRU Administrative Director, this position serves as the Manager of the Protocol Management Office (PMO) within the CRU.

This position is charged with general regulatory and financial oversight of all active clinical research studies from open to accrual through termination.

The position requires senior level input and contribution to the strategic planning related to the clinical research mission of the WVUCI.

This highly visible role includes joint responsibility and accountability with other Directors and Managers within the CRU for the success of the WVUCI clinical trials operations and for continuous improvement in the quality and efficiency of the clinical research program.

At WVU Research Corporation, we strongly believe in work-life balance and keeping time for things we love outside our work.

WVU Research Corporation offers a comprehensive benefits package with a variety of options to suit your needs :

• 13 paid holidays (staff holiday calendar)
• 403(b) retirement savings with a fully vested 3% employee contribution match, (Employees have the option of contributing an additional 1-3% of their earnings to the plan, which is also matched by the WVURC)
• A range of health insurance and various other benefits
• Dependent Education Scholarship
• WVU Perks
• And More!!

What you'll do :

• Office Oversight and Management :
• Incumbent is responsible for the supervision and management of the employees assigned to the PMO within the CRU including leading performance management and improvement efforts for the unit, time approvals, leave requests, work assignments etc.

This includes the following :

• Ensures that systems are in place for the effective, efficient, and accurate conduct of clinical trials. Works with other Unit Managers, CRU Leadership, and WVU Human Resources (HR) to develop and implement new systems as needed;
• Responsible for the ongoing workload assessment and reassignment of work as needed, requisitioning new staff as necessary with the approval of CRU Leadership and WVU HR;
• Manages resolution of problem-solving for issues arising from the conduct of clinical research activities. May involve departments within the Cancer Institute, WVU OHRP, Ruby Memorial Hospital and other entities at the WVU Health Science Center, as well as sub-site institutions participating in WVUCI investigator-initiated multi-site trials;
• Directs recruitment efforts and performance management for assigned unit in conjunction with CRU Leadership and WVU HR.
• Participates in interviews for other units as requested / appropriate;
• Develops training and onboarding programs for faculty and clinical research teams related to IIT management and protocol oversight, delegating tasks as appropriate to PMO and staff when necessary;
• Collaborates with WVU HR and CRU leadership to develop and update position descriptions;
• Provides mentorship to new PMO staff, including in-service training related to study maintenance, regulatory body (FDA, IRB, GCP, etc.
• updates, financial oversight, sponsor communications, oncological, clinical research, and patient care topics;
• Participates in the onboarding and continuing training and education of PMO and clinical research teams.
• Establishes and reinforces clear, measurable performance expectations under the direction of the WVUCI CRU Director;
• Acts as resource for protocol management staff in the auditing, monitoring, and review of research protocols and compliance issues.
• Serves on internal committees for the creation of SOPs, workflows, and metrics. Collaborates with leadership and support staff to implement and change policies and / or procedures;
• Participates in working groups and coordinates internal quality control activities in conjunction with internal Monitors and other related staff.
• Protocol Management
• Incumbent will serve as back-up and resource for Regulatory Coordinators in the conduct of their assigned activities and will oversee and ensure the compliance of the entire CRU portfolio.

Overall responsibilities can be broken out into the following :

• Manages CTMS (OnCore) PC Console and ensures personnel are optimizing use of software tools offered through CTMS to maximize efficiency and streamline processes;
• Establishes and maintains workflow timeline for amendment, annual and study close-out activities, identify problem areas and recommend ways to streamline or improve efficiencies;
• Participates in WVUCI disease team oriented research meetings, to also include research affiliate network, with investigators and coordinators to ensure prompt and accurate communication of changes in the protocol plan, IRB comments and other regulatory items.
• Provides data analysis and reports for Cancer leadership on clinical trials activity (close outs, newly opened, protocols under review);
• Serves as liaison in building and maintaining partnerships on behalf of WVUCI (institutional CRU, IRB, OCR, hospital, etc.

Actively participates as liaison with personnel involved with various clinical research components (Compliance, Clinical Trial Management, Finance, Regional Network) as well as external entities that wish to conduct clinical trials at WVUCI (e.

• g. Pharmaceutical companies, NIH, foundations, etc.);
• Responsible for understanding and interpreting the Code of Federal Regulations, Institutional Review Board policies and procedures as well as other regulatory policies and procedures regarding human subject research.
• Cooperates with University compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate personnel.

Coordinates and facilitates monitoring and auditing visits.

• Interacts with physician investigators to provide ongoing updates on protocols and regulatory issues.
• Partners with internal / external project and IT staff to create, review, analyze, interpret, summarize and prepare progress and final reports.

Assists investigators with poster, abstract, and manuscript layout / authoring including conducting literature searches and reference verification.

• Financial Clinical Trial Support
• Coordinates and reviews amendments to clinical trial agreements and protocols for updates to National Coverage Analysis and / or sponsor budget.
• Ensures financial reimbursement for regional and affiliated sites is processed in a timely manner.
• Oversees business development projects with leadership.

Qualifications

Bachelor's Degree in related field, preferably Nursing, Basic Sciences, Clinical Research and / or Health Sciences or an equivalent combination of education and experience.

Master's degree preferred

• A minimum of three (3) years of experience with research coordination and / or project management in clinical research
• Expert understanding of research ethics and the responsible conduct of research, with a focus on the regulations and guidelines governing human subject clinical trials
• Extensive experience in clinical research including proficiency with databases and / or patient data;
• Strong desire to learn, seek out, and apply new knowledge, methods, and information;
• Expertise in National Cancer Institute NCTN / ECTCN Cooperative group trials
• Strong interpersonal skills, as well as the ability to work with a broad range of people including investigators, physicians, clinic and hospital staff, sponsors, partners at other institutions, WVUCI staff, and others;
• Highly resourceful team-player, with the ability to also be extremely effective, independent, interact professionally, and utilize effective writing and organizational skills;
• Proven sense of professional ethics and conduct, understanding and effectively using and applying Emotional Intelligence strategies and skills
• Forward-thinking mentality, actively seeking opportunities and proposing creative solutions with strong decision-making capability;
• Proven ability to handle confidential information with discretion, be adaptable to various competing demands, and demonstrate the highest level of customer / client service and response;
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment;
• Demonstrated ability to establish and maintain effective working relationships with stakeholders and critical staff, both internally and externally, through a variety of communication mediums and venues;
• Project manager mindset and basic skills including : delegation, scheduling, communication, critical thinking, task and quality management, risk management, and flexibility
• Proficiency and / or training in project management and awareness of various project management modalities and techniques (PMI, Six Sigma, Agile, Scrum, etc.)
• Excellent meeting management, group facilitation, and consultation skills
• Highly collaborative and energetic management style;
• Prior experience as a supervisor or team lead and / or completion of leadership / management training program highly preferred
• Proficiency with Microsoft Office suite, particularly Outlook, Excel, Word..

Requirements

Research Certification with SOCRA or ACRP preferred or able to obtain within six (6) months of hire.

About Research Corporation

The WVURC was created as a not-for-profit corporation in 1985 to support research (R1) at West Virginia University. We provide evaluation, development, patenting, management, and marketing services for inventions of the faculty, staff and students of the University.

The WVURC receives and administers funds awarded by external agencies for research and other activities and is responsible for helping protect intellectual property through patents, copyrights and licensing agreements for start-up companies based on University research.

Creating an inclusive, engaged, and dynamic environment is core to WVURC's mission. We welcome candidates who can contribute a range of ideas, approaches and experiences.

West Virginia University Research Corporation is proud to be an Equal Opportunity employer. We value diversity among its employees and invites applications from all qualified applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.

Job Posting

Aug 9, 2024 Posting Classification : Research Corporation Exemption Status : Exempt Benefits Eligible : Yes

Schedule

Full-time