Sr Clinical Research Spec

Rochester, NY

GENERAL PURPOSE:

This position is an experienced Clinical Research Professional responsible for providing leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols. Under the ultimate responsibility of the Principal Investigator (PI) and/or leadership of the clinical trial, the individual in this position will have responsibilities for managing multiple studies’ including day-to-day operations, carry out all study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, and ensure each study's integrity. The individual in this role will monitor and maximize adherence to research standards, regulatory guidelines, and approved operational procedures; work closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to study protocol; manage study-related administrative and human resources tasks; and facilitate across-the-board flow of information, orchestrating study activities and personnel. The coordinators in this role will also be responsible for assisting in developing capacity and accruing participants across the entire Wilmot catchment area.

JOB DUTIES AND RESPONSIBILITIES:

Coordinate local clinical research projects

  • Provide research support to multiple principal investigators and project coordinators who are members of the Wilmot Cancer Prevention and Control Research program.

  • Provides support for studies conducted at various Wilmot Cancer Institute (WCI) locations across the catchment area.

  • Screen and identify potential study patients by participating in multidisciplinary clinics, reviewing clinic schedules, using MyChart, collaborating with CTSI, developing and disseminating marketing materials, and developing new effective methods for recruitment.

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

  • Schedule all patient study visits both face-to-face and electronic (e.g. Telemedicine, Zoom)

  • Maintain patient data such as consent forms, letters, and appointment notices.

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

  • Learn and administer new assessment techniques for study visits

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

  • 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 Documentation and Correspondence

  • Serve as point of contact for patients concerning study matters within the Wilmot Cancer Institute’s on- and 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 at other Wilmot locations to implement patient activities.

  • Consult regularly with physicians and other health care professionals involved with patients enrolled in studies

Regulatory Responsibilities

  • Participate in the preparation of study documents and regulatory approvals.

  • Review and/or edits study documents.

  • Manage regulatory documents for the duration of studies.

  • Organize documents for local audits.

Study Analysis

  • Assist with data analysis and 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 in order to accomplish a timely completion.

Other duties as assigned

QUALIFICATIONS:

Required:

  • Bachelor's degree in health-related, social science or appropriate field.

  • 2-3 years of clinical research of relevant work experience or equivalent combination of education and experience.

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.

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

  • Requires reliable/efficient transportation for travel to off-site locations.

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: $ 59,197 - $ 82,888 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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