QUALIFICATIONS:

• Bachelor’s Degree or equivalent combination of education and experience required
• 1 year of clinical research or relevant work experience
• or equivalent combination of education and experience required
• Fluent English language skills (oral and written) required.

GENERAL PURPOSE:

The Clinical Research Coordinator II (CRC II) is a mid-level Clinical Research Professional responsible for assisting in the planning, coordinating, implementing, monitoring, and evaluating specific clinical research studies as assigned. Under the ultimate responsibility of the Principal Investigator (PI) and the mentorship of a Supervisor or more senior CRC, the CRC II assists in the day-to-day operations in the implementation of clinical research protocols. S/he will assist in carrying out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines and will assist in assuring the overall integrity of studies. S/he will assist in monitoring and adhering to 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 approved protocols; help with study-related administrative tasks; facilitate across-the-board flow of information, and assist in coordinating study activities and personnel. S/he will also perform duties as assigned.

JOB DUTIES AND RESPONSIBILITIES:

Coordinates enrollment of participants

Independently manages and coordinates the enrollment of participants to moderate risk/moderately complex studies including the following tasks:

• 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 for 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.
• Accurately 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.

Independently manages and coordinates studies that are of a moderate size and complexity. Maintains study continuity, coordinates study participants and research procedures including the following tasks:

• Identifies and documents adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
• Performs data collection and data 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 and problem solves logistical challenges in protocol implementation with the research team, assisting in resolving challenges.
• Performs quality checks for data accuracy, reports/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, other departments.
• Adheres to cultural competency guidelines; implements strategies to meet study participants’ needs for language translation, health literacy, etc.

Maintains all logs, Research Tabs and OnCore

• 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.

Professional Development

• 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 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.

Preferred:

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

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.

Job Type: Full-time

Pay: From $50,128.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Evening shift
• Monday to Friday
• Overnight shift
• Overtime
• Weekend availability

Ability to commute/relocate:

• Rochester, NY: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• Clinical trials: 1 year (Preferred)
• Clinical research: 1 year (Preferred)

Work Location: In person

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