Research Project Manager

GENERAL PURPOSE:

Coordinates human subject research activities, which may include multiple site human subject studies. May provide training on federal, state, sponsor and/or institutional regulations, policies and practices related to human subject research. May supervisor others. With latitude for independent judgement, the Research Project Manager is responsible for coordinating the activities associated with human subject research and data management for supportive care and survivorship studies in children, adolescents and young adults with cancer. Daily activities include recruiting patients, completing study assessments, and managing study data and documents. Opportunities exist to become involved in research, including data analysis and literature reviews. Strong writing and verbal communication, excellent organizational skills, and inherent self-motivation are key to supporting large and small research studies that seek to increase representation of diverse and underrepresented populations. Interest and passion for helping children, adolescents, and young adults with cancer is integral for this position.

RESPONSIBILITIES:

Coordinate multiple high-volume clinical research projects

• Serve as the primary contact for protocol and data-related questions

• Assists in human subject recruitment and screening activities, including reviewing study site patient databases and office records for patients that meet the protocol inclusion criteria. May participate in developing recruitment strategies.

• Conduct telephone interviews to screen potential study candidates. Reviews medical chart history to verify inclusion criteria are met before enrollment. Obtains informed consent from participants.

• Conducts study visits to ensure research participant adherence with protocol requirements such as proper use of device and/or other interventional activities; to conduct various assessments with participants (e.g. neurocognitive, functional);

• Monitor studies regularly for conformity with standard operating procedures, and 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 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 assigned projects

• 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

• Oversee 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.

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

• Develop and produce reports of study data for project staff and stakeholders, including study deviations and adverse events.

• May participates in analysis and organizing of study reports and scientific communication (e.g., presentations, manuscripts) if interested

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 protocols and data forms for new projects under development

Study agents, supplies and equipment:

• Design and build biospecimen collection kits

• Retrieve, log and store biospecimens

• 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 with major course work in an appropriate health, social or technical field required.

• Master’s degree preferred.

• 2-3 years of related experience required.

• 1-3 years of clinical trials experience preferred

• or equivalent combination of education and experience

• 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 preferred.

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

• Increasing ability to develop strong relationships with research participants/patients preferred

• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet preferred

• Experience with data analysis and data analysis software packages are preferred.

• Professional Research Coordinator certification (SoCRA or ACRP) 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

Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Opening: Full Time 40 hours Grade 053
Schedule: 8 AM-5 PM