Clinical Trials Proj Mgr II

Rochester, NY

GENERAL PURPOSE:

The Clinical Research Project Manager (CRPM) position involves working with multiple principal investigators across multiple clinical trials with a wide variety of assessment methods including patient-reported, biological, physiological, and electronic data. Under the general guidance and with latitude for independent judgment, this individual will be responsible for developing and maintaining data capture standard operating procedures, clinical databases for national and local research studies, data processing and report generating procedures and preparing research datasets for analysis by statisticians and investigators. This individual will also be responsible for assisting with the purchase, set-up, inventory, and management of new data capture devices.

JOB DUTIES AND RESPONSIBILITIES:

Equipment, and Data Collection Management

  • Create standard operating procedures for equipment setup, software installation and update, device initiation, data collection, data download and export, data trimming and auditing

  • Calibrate equipment serve as a liaison with vendors to maintain measurement equipment (e.g., Biodex, Vyntus Metabolic System, Medgraphics Metabolic Systems BTS Bioengineering EMG sensors and G-Walk wearable system, RJL bioelectric impedance, AMTI forceplate, Firstbeat bodyguard, actigraphy and other wearable devices, and other equipment in the PEAK Human Performance Science Program)

  • Assist with administration and development of novel electronic platform interventions in the PEAK Human Performance Science Program (e.g., YOCAS, EXCAP applications)

  • Collaborate closely with principal investigators to develop methods for data capture using a wide variety of technologies for clinical research trials

  • Manage data collection, download, and export from research equipment and wearable system; perform dataset merging and analysis

  • Conducts ongoing data entry, review, trimming, and auditing (heart rate variability, actigraphy, electromyography, Biodex, G-Studio, metabolic; Vyntus Metabolic System, MedGraphics Metabolic System, body composition; RJL and other measures in the PEAK Human Performance Science Program)

  • Develop, manage, and optimizes data management processes

  • Develop and implement a systematic method for tracking research data from numerous sites using a wide variety of data capture methods and ensuring data quality and security

Research related activities

  • Use independent judgment on how and when to update project management data systems through feedback gathered from team meetings.

  • Facilitate processes to utilize data that enhances communication between team members about project goals, and assists the director and investigators in maintaining accountability for all team members to meet key milestones and deadlines.

  • Implement and manage remote exercise testing using technology for a wide variety of data capture methods and proficiency in exercise testing and leadership applications and software

  • Initiate and facilitates communication concerning PEAK data management, IT department, URCC NCORP Research Base IT team, director, and PEAK members.

  • Contribute to and assists the director and team members with scholarly endeavors, including collaborating on conference abstracts and scholarly papers for publication.

  • Recommend process improvements and technology solutions to optimize team functions.

  • Build and maintains connections with peers in offices throughout the University, locally, regionally, and nationally in order to facilitate benchmarking, establish best practices, and contribute to the professional community of practice.

  • Develop training materials for national studies; videos, manuals, webinars

  • Administer training sessions for national studies; live webinars

  • Work closely with study PI and team members to program data tracking, merging, and quality checking and prepare datasets for analyses

  • Assist with data interpretation using quantitative and qualitative methods

Maintains oversight of high-volume study data for the assigned projects:

  • 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.

  • Oversee receipt and verification of incoming data received from our community sites in multiple formats, i.e., REDCap, scannable paper forms, activity trackers, electronic cognitive assessments, heart rate monitors and audio recordings of treatment sessions.

  • Works collaboratively with Data Management to provide the study team and URCC leadership with accurate reports on status of data for assigned projects including – data processing status, outstanding data, and trends.

  • 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

Miscellaneous :

  • Serve as site auditor, primarily reviewing selected patient cases to ensure compliance with protocol; assist Lead Auditor in compiling information gathered during the audit for the final report to the NCI

  • Provide support and backup for projects assigned to other PEAK staff as needed.

  • Maintains current working knowledge of clinical research best practices, updates to federal regulatory, Good Clinical Practice, current industry standards for clinical research and project management professionals by regularly attending training sessions, meetings and conferences.

  • Needs to be available approximately 1-3x/year to travel overnight for meetings and/or conferences.

Other duties as assigned

QUALIFICATIONS:

Required:

  • Bachelor's degree in health field (e.g. kinesiology, biomechanics, exercise physiology, exercise psychology) or other related field

  • 2-3 years of relevant experience

  • or equivalent combination of education and experience

  • 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:

  • Excellent communication and organizational skills; attention to detail and problem-solving skills are essential. Ability to handle several projects simultaneously, prioritize and shift priorities quickly.

  • Knowledge and expertise in using human performance testing equipment (e.g. heart rate monitors, actigraphs, Garmin devices, Fitbits, heart rate variability monitors, MCG Diagnostics and Vyntus metabolic carts, Biodex, Bioelectrical Impedance, Electromyography (EMG), G-Sensor accelerometers) and associated software (e.g. Actilife, G-Studio, Medgraphics).

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

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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