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GENERAL PURPOSE:

The Clinical Research Project Manager (CRPM) is responsible for coordinating and managing study activities related to supportive care in children, adolescents, and young adults with cancer under a Principal Investigator (PI) in the Department of Surgery/Supportive Care in Cancer Research Program. Under general guidance and with latitude for exercise of independent judgment coordinate patient enrollment, schedules, and care in clinical research studies which may include multi-site, community-based research, or multiple therapeutic areas. Maintain a working knowledge of cohort study and clinical trial coordination by reviewing research literature, attending pertinent meetings and seminars, participate in the preparation of study documents and regulatory requirements. Complete regulatory requirements and develop study protocols, assessments and complete study visits and assessments.

RESPONSIBILITIES:

Research Study Activity Coordination

• Serve as the patient representative during development of studies and projects

• Screen and identify potential study patients by participating in multidisciplinary clinics and reviewing clinic schedules and consult materials

• Identify and provide for scheduling of study events for patients enrolled.

• Maintain patient data such as consent forms, letters, and appointment notices. Provide scheduling of study events for patients enrolled.

• Collect clinical data during all phases of care while patient is on study, i.e., medical record review, functional data, biological data; complete case report forms

• Assist investigator (Associate Professor) with developing, writing, and amending study protocols

• Assist in acquisition of clinical trial data and all study visits

• Assist with collection of biological and physiological data/samples and delivery to labs and basic processing

• Learn and administer new assessment techniques for study visits

• Monitor studies regularly for conformity with Unit, Cancer Center, University and CTO (Clinical Trials Office) standard operating

procedures, and verify data ensuring compliance with requirements of the protocol and federal regulations.

Study Administration and Project Management

• Serve as point of contact for patients concerning study matters within the Wilmot Cancer Institute’s off-site locations. Maintain and prepare detailed documentation of treatment and follow-up of enrolled patients. Update documentation of patient procedures or data as they occur.

• Coordinate appointments and correspondence with patients participating in studies. Collaborate with personnel in other departments and facilities

to implement patient activities. Consult regularly with physicians and other health care professionals involved with patients enrolled in studies.

Regulatory Responsibilities

• Participates in the preparation of study documents and regulatory approvals. Reviews and/or edits study documents.

• Complete regulatory paperwork and requirements for local and nationwide clinical trials

• Manages regulatory documents for the duration of studies

• Organizes documents for local audits

Study Analysis

• Assist with data management for long term projects.

• Review and evaluate patient data for statistical analysis and perform simple statistical analyses as needed

• Assist with preparation of materials for publication. Prepare and collate patient study information, status reports and updates as necessary for reporting on progress of patients enrolled in studies to accomplish a timely completion.

Other duties as assigned

QUALIFICATIONS:

Required:

• Bachelor’s degree in health or social science field

• 2-3 years of clinical trials experience

• Or equivalent combination of education and experience

Preferred:

• Excellent verbal and writing skills are required. Knowledge of all URMC software, websites and computer databases used for clinical trials, as well as, word processing, spreadsheets, online meeting and telemedicine platforms and graphics packages are required.

• Occasional evenings and weekends are required. Potential travel to off-site locations, requires reliable/efficient transportation.

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: $ 58,800 - $ 82,300 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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Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
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