Research and Development Manager jobs in Parkersburg, WV

The WVU Cancer Institute at West Virginia University Research Corporation is currently accepting applications for a (Hybrid) Protocol Development Manager.

The Protocol Development Office (PDO) as a unit within the WVU Cancer Institute Clinical Research Unit (WVUCI CRU) is tasked with the development, activation, and management of clinical research protocols to be conducted at the WVU Cancer Institute.

Under the direction of the WVUCI CRU Administrative Director, you will serve as the Manager of the Protocol Development Office (which serves as the Investigator-Initiated Trials (IIT) Management Team) of the CRU. You will be charged with general oversight of all protocol activation and protocol development activities of all clinical research studies within the office. This includes the development and authoring of investigator-initiated protocols in coordination with clinical investigators, study teams, and sponsors. This includes the management of both local and multi-site IITs and coordination with WVU pre-award, regulatory team members, core committees, network coordinator and statistical team. 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.

About the Opportunity

As a Job Title, you will add descriptive text about what the candidate will do - include a summary or the main objectives/tasks of the role.

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 ()
• PTO
• 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
• Dependent Education Scholarship
• WVU Perks
• And More!!

What you'll do:

Office Oversight & Management

• Responsible for the supervision and management of the employees assigned to the PDO within the CRU including leading performance management and improvement efforts for the unit, time approvals, leave requests, work assignments etc. This includes the following:
  • Ensure that systems are in place for the effective, efficient, and accurate conduct of clinical trials. Work 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.
  • Manage 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.
  • Direct recruitment efforts and performance management for assigned unit in conjunction with CRU Leadership and WVU HR. Participate in interviews for other units as requested/appropriate.
  • Develop training and onboarding programs for faculty and clinical research teams related to IIT management and protocol oversight, delegating tasks as appropriate to PDO and staff when necessary.
  • Collaborate with WVU HR and CRU leadership to develop and update position descriptions.
  • Provide mentorship to new PDO staff, including in-service training related to protocol authoring, study activation, regulatory body (FDA, IRB, GCP, etc.) updates, oncological, clinical research, and patient care topics.
  • Participate in the onboarding and continuing training and education of PDO and clinical research teams. May assign one-on-one mentor as available or necessary for satisfactory completion of training objectives.
  • Oversee training of staff in the management of protocol development activities, to include feasibility and activation committee management, Disease Team and PRMC submission, and cost coverage analysis calendars, and other clinical trials operations functions.
• Establish and reinforce clear, measurable performance expectations under the direction of the WVUCI CRU Director.
• Act as resource for protocol development staff in the auditing, monitoring, and review of research protocols and compliance issues as well as with the authoring, development, and management of IITs.
• Serve on internal committees for the creation of SOPs, workflows, and metrics. Collaborate with leadership and support staff to implement and change policies and/or procedures.
• Participate in working groups and coordinate internal quality control activities in conjunction with internal Monitors and other related staff.

Protocol Development and Management

• Serve as back-up for IIT Project Managers 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:
  • Manage CTMS (OnCore) protocol entry and ensure that personnel are optimizing use of software tools offered through CTMS to maximize efficiency and streamline processes.
  • Participate in leadership committees for clinical trials activation processes and state-wide affiliate network as assigned. Serve on institutional committees as needed.
  • Establish and maintain workflow timeline for trial activation, identify problem areas and recommend ways to streamline or improve efficiencies.
  • In coordination with the Director, maintain a complete workflow timeline and workload matrix for trial activation, and recommend ways to streamline or improve systems.
  • Provide data analysis and reports for Cancer leadership on clinical trials development and activation activity (close outs, newly opened, protocols under review).
  • Serve as liaison in building and maintaining partnerships on behalf of WVUCI (institutional CRU, IRB, OCR, hospital, etc.). Actively participate as liaison with personnel involved with various clinical research components (Compliance, Clinical Trial Management, Finance, Affiliate Network) as well as external entities that wish to conduct clinical trials at WVUCI (e.g. pharmaceutical companies, NIH, foundations, etc.)
  • Facilitate IIT Think Tank meetings through preparation of meeting agendas and minutes, presentation of IIT concepts, and timely follow up on meeting action items.

WVUCI Investigator Initiated Protocol Development Activities

• Manage a portfolio of IITs and coordinate the development activities for their portfolio. This includes the following:
  • Manage clinical and protocol development functions of clinical trials and/or drug studies, coordinates the authoring of research protocols, informed consent documents, and other study related materials in accordance with WVU, FDA, ICH and GCP guidelines. Responsible for maintaining version control of all trial related documents.
  • Maintain direct communication with investigators, clinic departments, funding sponsors, and research collaborators in support of the overall research plan; reports start-up progress to PIs and study staff ensuring transparency during the process and identifying any issues.
  • Collaborate with investigators, study staff and database support staff to develop data capture plan and tools.
  • Organize study protocol/operations conference calls, e-mail communications, and meetings. Tasks include polling call participants, distributing call announcements, agenda, meeting materials and minutes.
  • Help to ensure study team adheres to established timelines for project completion and reporting including posting of routine updates and results to clinicaltrials.gov.
• Coordination of regulatory services for IIT protocols with IRB coordinators and necessary offices:
  • 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.
  • Work with study teams to develop new objectives, goals, and performance measures for the study; works closely with study teams to ensure that the study direction is implemented timely and effectively.
  • Cooperate with University compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate personnel. Coordinate and facilitate monitoring and auditing visits. Notify appropriate institutional officials of external audits by FDA and sponsors.
  • Assist with data management, organization, and analysis of clinical research information. Partner with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress and final reports. Assist investigators with poster, abstract, and manuscript layout/authoring including conducting literature searches and reference verification.
  • Oversight of IIT project managers who are responsible for day-to-day project management of IITs.

Clinical Trial Support

• Incorporate medical knowledge into the review of clinical aspects of the protocol.
• Review studies for clinical processes and feasibility.
• Act as resource for clinical research staff in the administration and toxicity assessment of protocol regimens.
• Provide in-service education necessary to facilitate protocol compliance.
• Direct clinical concerns to the protocol PI and CRU leadership.

• Bachelor's degree, preferably in Nursing, Basic Sciences, Clinical Research and/or Health Sciences.
• 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.
• 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.).
• Exceptional ability to develop project and proposals and drive them to completion through collaboration with internal and external stakeholders across functions, including working directly with University and senior leadership to achieve the goals of ongoing projects.
• Excellent meeting management, group facilitation, and consultation skills.
• Highly collaborative and energetic management style.
• Proficiency with Microsoft Office suite, particularly Outlook, Excel, Word.

Preferred Qualifications:

• Master's degree, preferably in Nursing, Basic Sciences, Clinical Research and/or Health Sciences.
• Experience years of project management and/or study coordinator or other research experience in an academic clinical research facility or industry research facility and/or medical/clinical training.
• Experience as a supervisor or team lead and/or completion of leadership/management training program.
• Experience with Medicare Coverage Analysis determinations.
• Experience in clinical research including proficiency with databases and/or patient data.

Certifications:

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

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.