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GENERAL PURPOSE:

The Sr. Clinical Research Specialist position serves to support Dept. of Surgery Division of Supportive Care in Cancer trials at Wilmot Cancer Institute. The coordinator will be responsible for leading the planning, implementation, and conduct of interventional and non-interventional supportive care trials. Under oversight of the Sr. Clinical Research Project Manager, the Sr. Clinical Research Specialist will manage locally accruing studies’ day-to-day operations, carry out project management and study coordination for those clinical trials beginning with protocol development, initiation, study conduct to study close-out according to regulatory/NCI guidelines, and ensure each study’s integrity. S/he will monitor and maximize adherence to research standards, regulatory guidelines, and approved operational procedures; work closely with study team members and other staff/faculty from all cross functional teams to ensure study participant safety and adherence to study protocol; manage/coordinate study-related tasks; and facilitate across-the-board flow of information, orchestrating study activities and involved personnel. The Sr. Clinical Research Specialist will facilitate excellent customer service and guidance to clinical and research study team members.

JOB DUTIES AND RESPONSIBILITIES:

Manage all aspects of assigned locally accruing clinical research projects including:

• Serve as the primary study coordinator for protocol and data-related questions and issues.

• Develops and maintains a comprehensive workflow process for assigned each protocol and timeline of all tasks to be completed for each study that includes all project phases, material procurement, start-up processes, training and implementing changes where needed.

• Ensure research staff members understand and adhere to all aspects of assigned protocols, procedures, interventions, and standards for documentation and communication

• Train 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 locally accruing studies regularly for conformity with standard operating procedures, and verify data to ensure compliance with requirements of the protocol, 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 IRB, as needed

• Attend and present updates at PI oversight study team meetings

Maintains oversight of study data for the assigned projects:

• Work with IT and Biostatistical teams to establish appropriate data handling procedures, methods for collection, databases, coding keys, storage, and tracking of data for assigned projects.

• Provide the PIs and Supportive Care in Cancer Control leadership with accurate reports on status of data for assigned projects.

• 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

• Manages the assigned project during the critical development and launch period, and is responsible for working with the Principal Investigator(s) and all cross functional teams to assess the scope of work, deliverables, timelines, milestones and relevant metrics to track progress and ensure all deadlines are met successfully.

• Work with Principal Investigator(s) and study team in the development of protocols, data collection forms, training materials, and determining what study supplies will be needed and ordered on schedule as outlined at project kick off, evaluating any changes in plans and needs for adaptation.

• Review and edit the protocol and data forms with a high degree of attention to detail for new projects under development. Works across all teams to ensure all requirements are met, questions resolved and URCC policies and procedures are met.

Study samples, agents, supplies and equipment :

• Works with the URCC Biobank to design and build biospecimen collection kits and laboratory manuals and training materials.

• Maintain sample logs and database and track expiring supplies.

• Produce laboratory reports

Miscellaneous :

• Serve as local site monitor, 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 Dept. of Surgery Division of Supportive Care in Cancer CRPMs 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 and 3 years of clinical research or relevant work experience

• Fluent English language skills (verbal and written)

• CCRP - Certified Clinical Research Professional by the Association of Clinical Research Professionals (ACRP) within 1 year

or

• OCRA - Certification in Clinical Research within 1 year

Preferred:

• Ability to effectively manage complex research protocols/procedures

• Proficiency in medical terminology, the clinical research process and applicable regulatory guidelines, standards

• Proficiency in managing multiple and competing priorities/demands

• Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation

• Fully adheres to applicable safety and/or infection control standards

• Exceptional interpersonal, organizational, and time management skills; highly collaborative, promotes teamwork

• Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients)

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

• Possesses a high degree of self-motivation

• Recognized ability to function independently

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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Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
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