Manager Clinical Trials (Hybrid) – Neurology Full-time

Clinical Research Coordinator

Directly responsible for the supervision, oversight, training, and education of research coordinators. Participates in quality assurance monitoring of data in research studies within the Pestronk Clinical Neuromuscular Lab. This position is responsible for day-to-day operations related to clinical research activity of the Pestronk Research Studies and certain lab duties, including research studies, for the Pestronk Lab within Washington University. Under the direction of Dr. Alan Pestronk, this position is responsible for providing leadership within this clinical research enterprise. Components of the leadership include protocol development, reporting activities, committee service and management, clinical research education/training and QA/QI initiatives. In concert with Dr. Alan Pestronk, this position is the research administrative leader for all clinical research involving Dr. Alan Pestronk as Primary Principal Investigator. This position reports to Dr. Alan Pestronk within the Pestronk Group. This position requires the ability to clinically assess protocols and laboratory research studies for budgetary and logistical issues associated with the coordination and implementation of clinical trials for institutional studies, cooperative group studies, and industry-sponsored studies, and accumulate and analyze data. Components of the role include protocol development, regulatory submission, grant writing, data analysis, finances, human resources, and leadership of clinical research staff.

Primary Duties & Responsibilities:

Strategy/Strategic Planning

• Contribute to strategic discussions, ideas, etc., and assist in carrying out its implementation.
• Contribute to the development of project and operational timelines.
• Expand knowledge and train on timeline development and management.
• Collaborates with PI and regularly serves as Co-PI to design, perform, and evaluate research procedures; confers with Co-PI to assist in developing plans for research projects and discuss the interpretation of results; collaborates in the preparation of contracts and proposals to sponsoring agencies; assists in the preparation of amendments to protocols and/or modifications to study design as appropriate.
• Works with PIs to design, perform, and evaluate operational procedures; confers with PIs to assist in developing plans for research projects, serves as a backup resource for study feasibility discussions and interpretation of results; may assist in the preparation of manuscripts for publications.
• Researches and recommends new methods and procedures to maintain standards and improve quality. Manages and reviews study enrollment and consent metrics. Makes recommendations to improve enrollment. Corresponds with study sponsors regarding questionnaires, budgets, CTAs and other contracts, etc.

Clinical Laboratory Development

• Participating and contributing member in Neuromuscular Laboratory Clinical research leadership group.
• Attend and participate in laboratory meetings; Discuss with functional and research areas.
• Support laboratory clinical research meetings; manage minutes and agendas for clinical research group meetings.
• Develop & analyze data for Clinical laboratory research.

Functional Area and Study Support Management

• Manage study supporters and compliance and quality of contracted scope with support/guidance from the director-level.
• Strong grasp of vendor scopes and budget / contract although not independent; invoice review.
• Support full scope of study conduct (Clinical Research Operations) in collaboration with Clinical Research Supervisor and Administrative Operations to ensure the trials are implemented and conducted according to the Code of Federal Regulations, Good Clinical Practices, ICH Guidelines, local regulatory requirements and Washington University SOPs.
• Promotes / maintains good public relations with all research faculty, staff, central regulatory / compliance offices at WU, grants team, and study subjects.

Personnel and Administrative Management

• Manage functional areas with minimal support from director-level.
• Manage team members at the project level based on responsible functional areas.
• Has direct reports.
• Serves as a resource to clinical research staff, ensuring mentorship and oversight of studies and policies and procedures; ensures that research projects are completed according to IRB and federal guidelines. Assigns studies, monitors workload, and provides supervision for all staff. May manage studies assigned as a lead coordinator as needed; assists all other research staff with overall workflow. Works with PIs and research RN staff to provide study training to the research coordinators within the Pestronk group.
• Provides high level of direct and indirect administrative, operational, and fiscal management support to PIs within the Pestronk Lab.
• Assists Dr. Alan Pestronk in the ongoing development and growth of the clinical, laboratory, and translational research enterprise as well as smooth administrative and operational workflow.
• Develops and implements policies and procedures; provides comprehensive direction to clinical research personnel; manages the hiring, training, and evaluation of clinical research staff.
• Assists in protocol development, oversight of site visits, monitor visits, enrollment and consent of patients, amendments and study close out procedures for a variable number of industry sponsored studies.
• May provide study coordinator functions as needed and perform all duties associated with the coordination and implementation of clinical research projects, data collection, and the management of data generated by study protocols.

Other Job Duties specific to Dr. Pestronk:

• Will serve as Primary Clinical Evaluator for all Alan Pestronk-related studies moving forward beyond the existing studies and those already established on our research pipeline (that have yet to start enrollment).
• Clinical and study physical therapy related-duties, to include, but not limited to, assisting in the education and training of clinical staff and fellows and managing patients with neuromuscular disorders.

Working Conditions:

Job Location/Working Conditions

• Normal office environment

Physical Effort

• Typically sitting at desk or table
• Repetitive wrist, hand or finger movement (PC Typing)

Equipment

• Office equipment

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

WashU seeks highly motivated individuals who are able to perform duties in a manner consistent with our core mission and guiding principles.

Grade: G14

Salary Range: $75,200.00 – $128,800.00 / Annually

For frequently asked questions about the application process, please refer to our External Applicant FAQ.

If you are unable to use our online application system and would like an accommodation, please email CandidateQuestions@wustl.edu or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voicemail with the nature of your request.

All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.

All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.

Personal

• Up to 22 days of vacation, 10 recognized holidays, and sick time.
• Competitive health insurance packages with priority appointments and lower copays/coinsurance.
• Take advantage of our free Metro transit U-Pass for eligible employees.
• WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.

Wellness

• Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!

Family

• We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We've got you covered.
• WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.

For policies, detailed benefits, and eligibility, please visit: https://hr.wustl.edu/benefits/