Human Subject Res Spec II

University of Rochester; City of Rochester (NY); On-site; USD 72,036,000 - 100,977,000; Full time

Job summary

University of Rochester Translational Pain Research Program is seeking a Clinical Trials Coordinator II to oversee human subject studies, coordinating recruitment, consent, visit conduct, source documentation, and data entry in a collaborative, compliant environment.

The role requires a Bachelor's degree with 2 years of experience in human subject research coordination; experience as a Phlebotomist and Spanish fluency are highly preferred.

Qualifications

• Bachelor's degree and 2 years of experience in human subject research coordination required.
• Or equivalent combination of education and experience.
• Experience as a Phlebotomist preferred.
• Word processing and data analysis software required.
• SOCRA Certification in Clinical Research upon hire preferred.
• ACRP Certification upon hire preferred.

Responsibilities

• Screen potential study participants for eligibility in clinical trials.
• Conduct FDA-registration quality clinical trial visits, including, consenting, visit assessments, intervention distribution, and blood processing.
• Accurately record source documentation and enter data into electronic data capture systems.
• Ensure compliance with regulatory requirements and liase with study monitors.
• Participate in preparing investigator-initiated clinical trial materials (e.g., protocols, consent forms, recruitment materials, assessments, participant study-related instructions).
• Other duties as assigned

Skills

Spanish fluency

Education

Bachelor's degree

SOCRA Certification

ACRP Certification

Job description

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):
601 Elmwood Ave, Rochester, New York, United States of America, 14642
Opening:
Worker Subtype:
Regular
Time Type:
Full time
Scheduled Weekly Hours:
40
Department:
400157 Anesthes & Periop Med Research
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:
Coordinates human subject research activities, which may include multiple site human subject studies. May provide training on federal, state, sponsor and/or institutional regulations, policies and practices related to human subject research. Develops, implements and evaluates recruitment strategies, information, data systems and study management systems. Participates in the development, review and approval of case report forms (CRFs) and study-specific procedure manuals and documents.
Clinical trials coordinator II for the University of Rochester Translational Pain Research Program. Responsibilities include all aspects of conducting pain clinical trials in accordance with all regulations, including recruitment, consenting, visit conduct, source documentation, data entry, and proper adverse event documentation. The coordinator will work in a highly collaborative and supportive environment with senior coordinators, a post-doctoral fellow, and lead investigator who will work together to ensure that the candidate is adequately trained before working independently. Previous human subjects coordinator experience is preferred, but the position can be altered for the right candidate who is open to being trained. Spanish fluency is highly preferred and ability to draw blood or willingness to be trained to draw blood is highly preferred. Medical background (e.g., nurse or patient care technician) is ideal, but not necessary.
Responsibilities:

• Screen potential study participants for eligibility in clinical trials.
• Conduct FDA-registration quality clinical trial visits, including, consenting, visit assessments, intervention distribution, and blood processing.
• Accurately record source documentation and enter data into electronic data capture systems.
• Ensure compliance with regulatory requirements and liase with study monitors.
• Participate in preparing investigator-inodiated clinical trial materials (e.g., protocols, consent forms, recruitment materials, assessments, participant study-related instructions).
• Other duties as assigned

Requirements:Bachelor's degree and 2 years of experience in human subject research coordination required; Or equivalent combination of education and experience; Experience as a Phlebotomist preferred; Word processing and data analysis software required; SOCRA - Certification In Clinical Research upon hire preferred; Association of Clinical Research Professionals (ACRP) upon hire 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.