Human Subject Research Spec I

2 weeks ago

Rochester, United States University of Rochester Full time

GENERAL PURPOSE:

Coordinates the activities associated with human subject research. This person will be responsible for recruitment and have administrative responsibilities, including screening and recruiting subjects, performing informed consenting and interviews, completing data entry, and performing medical chart reviews. They will review study protocols, ensure thorough understanding and communication, respond to questions that arise during the study, communicate and document adverse events as advised by the Principal Investigator, and ensure regulatory and other documents (such as consent forms and CRFs) are complete, accurate and available for review.

**JOB DUTIES AND RESPONSIBILITIES:**

+ Coordinates the administrative details required to initiate and conduct human subject research, including receiving, distributing and explaining study information, such as protocol and human subject recruitment materials, to immediate team members and relevant others. Participate in project start up including applying for IRB, GCRC, and IBC approvals. Prepare documents for regulatory agencies including WIRB, RSRB, GCRCC and FDA. May assist in the design of protocols.

+ Assists in human subject recruitment and screening activities, including reviewing study site patient databases and medical records for patients that meet the protocol inclusion criteria. May participate in developing recruitment strategies. May conduct telephone interviews to screen potential study candidates. Reviews medical chart history with senior research staff, Research Manager and/or Principal Investigator to verify inclusion criteria are met before enrollment.

+ Conducts visits to ensure research participant adherence with protocol requirements, such as completion of surveys, taking of medications, proper use of device, and/or other interventional activities, reporting adverse events to senior study staff, Research Manager, PI, Institutional Review Board (IRB), Sponsor, and/or any other required recipients or entities. Ensures all data is collected and secured within approved parameters and procedures.

+ Understand and adhere to all aspects of all approved protocols, procedures, and standards for documentation and communication. Under general direction from the Research Manager and Principal Investigator (PI), communicates details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, source documentation and case report form (CRFs) completion, and adverse event reporting to all immediate and extended team members.

+ Perform tests according to research protocol, including phlebotomy, ECG, specimen collection, and functional measures as deemed necessary for each study protocol.

+ Acts as liaison with Sponsor's Monitor to provide data clarifications, reviews study protocols, ensures thorough understanding and communication, responds to questions that arise during the study, communicates and documents adverse events as advised by the PI and ensures regulatory and other documents, such as consent forms and CRFs, are complete, accurate, and available for review. Communicates with Sponsor to clarify data queries to determine report format. Prepares for, participates in, and serves as liaison for scheduled Sponsor monitoring visits (i.e. pre-study inspection, initiation, on- going and close out visits).

+ Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines and makes recommendations. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies. Makes recommendations and implements changes as appropriate.

+ Code data for purposes of data entry. Review and respond to data queries. Maintenance and protection of patient data.

Other duties as assigned

**QUALIFICATIONS:**

+ Bachelor's degree required

+ Completion of 6 months in the Human Subject Research Coordinator Trainee Program or

+ Equivalent combination of education and experience required

+ Experience as a Phlebotomist preferred

+ Word processing and data analysis software preferred

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.

**How To Apply**

All applicants must apply online.

_EOE Minorities/Females/Protected Veterans/Disabled_

**Pay Range**

Pay Range: $20.92 - $29.29 Hourly

_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._

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