Clinical Research Spec II

University of Rochester; City of Rochester (NY); On-site; USD 35,000 - 49,000; Full time

Job summary

The University of Rochester seeks a Clinical Research Coordinator to support planning, coordinating, and monitoring clinical studies in the 400178 Cancer Center/Clin Trials Office. You will assist with protocol initiation through close-out, ensure data integrity, and maintain documentation across sites and sponsor guidelines.

Strong organizational and communication skills, familiarity with MS Office, and a commitment to safety and regulatory compliance are required.

Qualifications

• Bachelor's degree and 1 year of relevant experience required
• Or equivalent combination of education and experience
• Ability to understand, follow and coordinate standard research protocols and procedures required
• Fully adheres to applicable safety and/or infection control standards required
• Understands and follows data integrity standards and processes required
• Strong interpersonal, communication, and organizational skills preferred
• Highly collaborative, ability to work well in teams preferred
• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet preferred

Responsibilities

• Assists in the planning, coordinating, implementing, monitoring, and evaluating specific clinical research studies as assigned.
• Assists in day-to-day operations and the implementation of clinical research protocols.
• Assists in carrying out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines.
• Assists in assuring the overall integrity of studies.
• Assists in monitoring and adhering to standards, regulatory guidelines, and approved operational procedures.
• Works closely with study team members and other study sites to ensure study participant safety and adherence to approved protocols.
• Helps with study-related administrative tasks, facilitates the across-the-board flow of information, and assists in coordinating study activities and personnel.

Skills

Coordination

Study enrollment

Data entry

Communication

Organizational skills

MS Office

Education

Bachelor's degree

Job description

Department

400178 Cancer Center/Clin Trials Ofc

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

Job Location (Full Address)

275 Hutchison Rd, Rochester, New York, United States of America, 14627

Opening

Worker Subtype: Regular

Time Type

Full time

Scheduled Weekly Hours

40

Department

400178 Cancer Center/Clin Trials Ofc

Work Shift

UR - Day (United States of America)

Range

UR URG 108 H

Compensation Range

$25.14 - $35.24

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.

Responsibilities

Assists in the planning, coordinating, implementing, monitoring, and evaluating specific clinical research studies as assigned. Assists in day-to-day operations and the implementation of clinical research protocols. Assists in carrying out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines. Assists in assuring the overall integrity of studies. Assists in monitoring and adhering to standards, regulatory guidelines, and approved operational procedures. Works closely with study team members and other study sites to ensure study participant safety and adherence to approved protocols. Helps with study-related administrative tasks, facilitates the across-the-board flow of information, and assists in coordinating study activities and personnel.

Essential Functions

• Coordinates enrollment of participants. Manages and coordinates the enrollment of participants in moderate risk/moderately complex studies. Participates in recruitment activities and performs screening and eligibility checks for potential study participants. Addresses e-mail and phone inquiries, participates in discussions with candidates in clinic, and consents to non-treatment trials. Assists in planning study timelines and schedules appointments and study visits. Manages and organizes case report forms, source documents, and research records. Enters research data into data collection forms and/or study databases. Assists in conducting quality checks for data accuracy with data source records as assigned.
• Manages and coordinates studies that are of a moderate size and complexity. Maintains study continuity and coordinates study participants and research procedures. Identifies and documents adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study. Performs data collection and entry activities according to protocol requirements and established operational procedures and timelines. Observes for deviations and takes action to minimize them. Reports and documents deviations when they occur. Identifies logistical challenges in protocol implementation with the research team, assisting in resolving challenges. Performs quality checks for data accuracy, reports, and follows-up with discrepancies. Assists in safety and quality improvement efforts, minimizing risk/safety threats. Prepares for and responds to internal and external audits. Effectively communicates with the research team, sponsor, data coordinating centers, compliance monitors, collaborators, investigators, academic, administrative personnel, and other departments. Adheres to cultural competency guidelines. Implements strategies to meet study participants’ needs for language translation, health literacy, etc.
• Maintains all logs, including OnCore entry and research tabs in the EMR, according to UR and department Standard Operating Procedures (SOPs). Assists in identifying and developing data collection tools. Assists the data coordinator in data tasks.
• Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines. Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. Maintains CITI and Conflict of Interest (COI) certification and renewal as required. Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols. Assumes personal responsibility for keeping up with new developments in the field, related literature, and relevant clinical standards. Assists in helping others in the same. Participates in protocol-related training as required.
• Complies with Good Clinical Practice and the Code of Federal Regulations. Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies.
• Other duties as assigned.

Minimum Education & Experience

• Bachelor's degree and 1 year of relevant experience required
• Or equivalent combination of education and experience

Knowledge, Skills And Abilities

• Ability to understand, follow and coordinate standard research protocols and procedures required
• Fully adheres to applicable safety and/or infection control standards required
• Understands and follows data integrity standards and processes required
• Strong interpersonal, communication, and organizational skills preferred
• Highly collaborative, ability to work well in teams preferred
• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet preferred

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture 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 characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.