NCORP Research Project Manager - DiRECT

GENERAL PURPOSE

With latitude for independent judgement, the NCORP Research Project Manager is responsible for assisting with coordinating the day-to-day operations of large, multi-site biomedical and/or social-behavioral clinical trial within the URCC NCORP Research Base. This position serves as liaison between the Research Base and clinical research personnel at off-site locations, including investigators, physicians, nurses, study coordinators, and clinic staff, in all phases of assigned clinical research protocols. Working collaboratively with the PI, other NCORP coordinators, multidisciplinary research teams, and clinical sites across the United States, plan and execute required aspects of each research project..

JOB DUTIES AND RESPONSIBILITIES:

Assist in coordination of multiple components of a high volume, multisite clinical research project including:

• Serve as a contact for protocol and data-related questions and issues from off-site locations (typically 20-100) nationally

• Ensure off-site investigators and their clinical research staff understand and adhere to all aspects of assigned protocols, procedures, interventions, and standards for documentation and communication

• Train site research staff on details of study activities, including inclusion and exclusion criteria, informed consent procedures, process for source documentation and case report form (CRF) completion, and adverse event reporting

• Assist with monitoring the studies regularly for conformity with standard operating procedures, and verify data to ensure compliance with requirements of the protocol, Research Base, IRB, University and federal regulations

• Track study-specific metrics (i.e., overdue data, open queries, etc.) and ensures issues are addressed promptly.

• Learn and maintain working knowledge of software and/or specialized equipment, procedures and interventions used in each project

• Develop and maintain workflow, records of research activities, and prepare periodic and ad hoc reports, as required by investigators and/or regulatory bodies.

• Ensure protocol timelines are met-patient, study, data

• Ensure proper reporting of adverse events to PI and Research Base Administration

• Attend and present updates at weekly study management team meetings

Manage complex, high volume study data for the assigned project

• Develop appropriate data handling procedures, methods for collection, databases, coding keys, storage, and tracking of data

• Receive and verify incoming data in multiple formats, i.e., REDCap, scannable paper forms, activity trackers, electronic cognitive assessments, heart rate monitors and audio recordings of treatment sessions

• Assist in overseeing data entry, engage in data audit activities such as chart review; verify data received are complete, accurate and submitted in a timely manner

• 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

• Assist Principal Investigator and study team in the development of protocols, data collection forms, training materials

• Create patient instructions and calendars

• Develop data tracking forms for new clinical trials

• Determine supply requirements for new projects and order supplies

• Review and edit the protocol and data forms for new projects under development

Study agents, supplies and equipment

• Assist Investigational Drug Service in distribution of study agent to off-site locations

• Design and build biospecimen collection kits

• Receive requests for and ship study-specific drug, supplies and equipment (e.g., devices such as activity trackers, heart rate monitors TENS units, recording equipment, training materials, manuals) for active clinical trials

• Maintain shipping logs and database, track expiring supplies and communicate with sites, replace with in-date supplies

• Retrieve, log and store biospecimens received from off-site locations

• Produce laboratory reports

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 coordinator support and backup for studies assigned to other Research Base coordinators as needed

Other duties as assigned

QUALIFICATIONS:

• Bachelor's degree in health or social science field required

• 2-3 years of clinical trials experience or equivalent combination of education and experience required

• 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 of computer databases, word processing, spreadsheets and graphics packages are important preferred.

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: $ 41,746 - $ 56,347 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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Full/Part Time: Full-Time
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