Clinical Trials Proj Mgr II

Rochester, NY

GENERAL PURPOSE:

This position requires working with cancer patients and survivors at Wilmot Cancer Institute locations by managing all research activities for ReNEW within the PEAK Human Performance Science Program; a clinical and implementation exercise oncology research program primarily located at the Pluta Integrative Oncology Center. This position will also have duties supporting additional local and nationwide research studies conducted by PEAK, the University of Rochester Cancer Center (URCC) National Cancer Institute (NCI) Community Oncology Research Program (NCORP), the Wilmot Cancer Prevention and Control Program and the Wilmot Human Biophysiology Shared Resource. This individual will be responsible for oversight of all activities at the Pluta Cancer Center location (e.g., oncology clinics, Integrative Oncology Center) and other locations as needed.

JOB DUTIES AND RESPONSIBILITIES:

Management of the ReNEW research program

  • Position responsible for performing all activities related to clinical and implementation research related to safe and successful physical activity intervention of cancer patients

  • Conduct one-on-one and small group physical activity interventions with patients

  • Oversight of patients throughout their physical activity intervention sessions

  • Be able to recognize health related emergency situations and provide necessary emergency response care

Maintains oversight of patient data

  • Organize, store, analyze, and report patient data

  • Work with Data Management, IT and Biostatistical teams to establish appropriate data handling procedures, methods for collection, databases, coding keys, storage, and tracking of data for assigned projects.

  • Analyze and suggest improvements in flow of information, error detection/correction, etc.

  • Maintain database integrity; review and evaluate patient data for statistical analysis, work with biostatistics team to resolve discrepancies or problems

  • Develop and produce reports of study data for project staff and stakeholders, including study deviations and adverse events. Contributes meaningful information to enhance publications or grant applications

Study development – Implementation Research

  • Manages the assigned project during the critical development and launch period, and is responsible for working with the Principal Investigator(s) and all cross functional teams to assess the scope of work, deliverables, timelines, milestones and relevant metrics to track progress and ensure all deadlines are met successfully.

  • Work with Principal Investigator(s) and study team in the development of protocols, data collection forms, training materials, and determining what study supplies will be needed and ordered on schedule as outlined at project kick off, evaluating any changes in plans and needs for adaptation.

  • Screen, consent, and perform study assessments

  • Review and edit the protocol and data forms with a high degree of attention to detail for new projects under development.

  • Works across all teams to ensure all requirements are met, questions resolved and URCC policies and procedures are met.

Execute data analysis and various other research tasks associated with the PEAK Human Performance Science Program

  • Report to PEAK Human Performance Science Program manager regarding renew clinical exercise program milestones and progress

  • Sleep and wake time Actigraphy data analysis

  • Heart Rate Variability data analysis

  • Compile and organize data regarding Biodex, bioelectrical impedance, and metabolic testing systems

  • Assist in study coordination tasks

  • Assist in local study recruitment

  • Assist in intervention development and implementation

  • Assist in study procedure SOPs and instruction documents

  • Exemplify suburb attention to detail and data analysis skills

  • Assist in local and nationwide study intervention delivery

Management of the facility and related administrative tasks

  • Maintain the ReNEW research program facility; physiologic testing equipment maintenance, and supply inventory

  • Communicates effectively with health care staff, Integrative Oncology Center staff, and PEAK staff Empathetic and professional regarding patients’ diagnosis, prognosis, and associated feelings and symptoms/side effects

  • Screen the electronic medical record and acquire clearance for physical activity for patients with known disease per American College of Sports Medicine guidelines

Professional Development

  • Maintain working knowledge of the specialty as well as the current exercise recommendations, industry standards and good clinical practices for conducting exercise testing and prescription and research tasks.

  • Attend meetings and pertinent seminars in academic settings.

Other projects and duties as assigned.

QUALIFICATIONS:

Required:

  • Bachelor’s Degree in Exercise Science, Kinesiology, or related field

  • 1 year of experience with exercise testing and prescription or equivalent combination of education and experience

  • Fluent English language skills (oral and written).

  • Knowledge of GCP and applicable regulatory guidelines

  • Knowledge of computer databases, MS Office (e.g. Word, Excel, and PowerPoint), REDCap, Zoom, Microsoft Teams, email, internet, and graphics packages are important

  • Experience in clinical electronic data capture (EDC) systems

  • Proven data management skills

  • Excellent verbal and written communication skills

  • Self-motivated and proactive

  • Strong attention to detail, adaptable, and flexible

  • American College of Sports Medicine (ACSM) Certified Exercise Physiologist (EP), or Clinical Exercise Physiologist (CEP)

  • American College of Sports Medicine (ACSM) Certified Cancer Exercise Trainer

  • (Candidates in the process of preparing for the exam will be considered, passing and obtaining certification is required within the first 6 months of employment)

  • CPR/AED BLS certified

Preferred:

  • Experience with exercise testing and prescription with clinical populations

  • Experience with conducting clinical research

  • Reliable and collaborative team member

  • Demonstrated leadership skills and competency. Ability to effectively manage complex research protocols/procedures.

  • Proficiency in managing multiple and competing priorities/demands.

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

Pay Range

Pay Range: $62,525 - $93,766 Annually

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

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