Human Sub Research Spec II

University-of-Rochester; City of Rochester (NY); On-site; USD 52,000 - 73,000; Full time

Job summary

University of Rochester seeks a research coordinator for the Cardiology Division to support pharmaceutical and device clinical trials. You will manage start-up activities, recruit and consent participants, and ensure compliance with GCP and sponsor requirements.

The role emphasizes 80% on-site work with some remote tasks, under supervision of the Principal Investigator, and requires a Bachelor's degree with 2 years of research coordination experience.

Qualifications

• Bachelor's degree and 2 years of experience in human subject research coordination.
• SOCRA certification or ACRP preferred upon hire.

Responsibilities

• Coordinate clinical trial activities under the PI, including start-up and enrollment.
• Ensure regulatory and GCP compliance and IRB/RSRB submissions.
• Conduct visits to verify protocol adherence and participant eligibility.
• Assist with data collection, case report forms, and adverse event reporting.

Skills

Word processing

Data analysis

Phlebotomy

EKG procedures

Education

Bachelor's degree

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, 14642Opening:Worker Subtype:RegularTime Type:Full timeScheduled Weekly Hours:40Department:400054 Medicine M&D-Cardiology DivWork Shift:UR - Day (United States of America)Range:UR URG 108 HCompensation Range:$25.14 - $35.24The 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:This position supports the Cardiology Division as a research coordinator in pharmaceutical and device clinical trials. Typical duties will include but are not limited to: conducting study protocols as the primary coordinator, with responsibility for study start-up activities such as WIRB and RSRB submissions, recruitment and enrollment and entire conduct of given study under the direction of the Principal Investigator. Ensures compliance with all applicable regulatory and institutional requirements and standards as well as compliance with Good Clinical Practice (GCP) guidelines and sponsor requirements. This position is 80% on-site, 20% remote. This person will be committed to providing high quality research efforts on the Cardiology Division's behalf.ESSENTIAL FUNCTIONSConducts visits to ensure research participant adherence with protocol requirements. Dispensing of investigational medications and devices, performing procedures as required by protocols (obtaining lab specimens, performing electrocardiograms, collecting data while observing electrophysiology, diagnostic, interventional cardiology procedures, exercise testing, drawing of bloods, etc.).Recruiting/screening/consenting/enrollment of patients, record reviews and interviews. Reviews medical chart history with PI to verify inclusion criteria are met before enrollmentCoordinates the administrative details required to initiate and conduct human subject research, such as IRB submissions and regulatory document collection.Receiving, distributing, and explaining study information, including protocol, and human subject recruitment materials to immediate team members and relevant othersEnsures all immediate and extended team members understand and adhere to all aspects of all approved protocols, procedures and standards for documentation and communication. Under general direction from the Principal Investigator, trains staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, process for source documentation and case report form (CRFs) completion, and adverse event reporting.Filling out case report forms, creating patient instructions and calendars, scheduling patient appointments, and assisting the investigators as needed.Prepares for, participates in and serves as a liaison for sponsor monitoring visits. Develops good working relationship with sponsors to foster a positive research environment and attend study Investigator/Coordinator meetings as required for study start-up.Collection and Reporting of adverse and serious adverse events to sponsor.Other duties as assignedMINIMUM EDUCATION & EXPERIENCEBachelor's degree and 2 years of experience in human subject research coordination requiredOr equivalent combination of education and experienceIf applicable, department specific experience requiredExperience as a Phlebotomist preferredKNOWLEDGE, SKILLS AND ABILITIESWord processing and data analysis software requiredClinical skills in phlebotomy, and EKG’s preferredLICENSES AND CERTIFICATIONSSOCRA - Certification In Clinical Research upon hire preferredAssociation of Clinical Research Professionals (ACRP) upon hire preferredThe 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.