Job Information
University of Rochester Clinical Research Specialist II in Rochester, New York
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):
90 Crittenden Blvd, Rochester, New York, United States of America, 14642
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
Compensation Range:
$51,810.00 - $72,534.00
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 the day-to-day operations in 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 across-the-board flow of information, and assists in coordinating study activities, and personnel.
JOB DUTIES AND RESPONSIBILITIES:
Participates in recruitment activities, and performs screening and eligibility checks for potential study participants.
Addresses email 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.
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.
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, including OnCore entry and research tabs in the EMR, according to UR and department Standard Operating Procedures (SOPs).
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.
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.
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.
Preferred:
Ability to understand, follow and coordinate standard research protocols and procedures
Understands and follows data integrity standards and processes.
Strong interpersonal, communication (verbal and written), and organizational skills.
EOE Minorities / Females / Protected Veterans / Disabled:
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.
Notice: If you are a Current Employee, please log into myURHR to search for and apply to jobs using the Jobs Hub. Your application, if submitted using this portal, cannot be moved forward.
Learn. Discover. Heal. Create.
Located in western New York, Rochester is our namesake and our home. One of the world’s leading research universities, Rochester has a long tradition of breaking boundaries—always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better.
If you’re looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals
At the University of Rochester, we commit to diversity, equity, and inclusion and united by a strong commitment to be ever better—Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.
University of Rochester
- University of Rochester Jobs