University of Rochester

University of Rochester, located on the banks of the Genesee River in Rochester, New York, is a four-year private institution of higher learning that has offered educational opport

Project Coordinator

Location

United States

Posted

4 days ago

Salary

$21 - $30 / hour

Seniority

Mid Level

No structured requirement data.

Job Description

Project Coordinator

University of Rochester

Role Description Coordinates the activities associated with human subject research. - 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. - Assists in human subject recruitment and screening activities, including: - Reviewing study site patient databases and office records for patients that meet the protocol inclusion criteria. - Participating in developing recruitment strategies. - Conducting telephone interviews to screen potential study candidates. - Reviewing medical chart history with Principal Investigator to verify inclusion criteria are met before enrollment. - Conducts visits to ensure research participant adherence with protocol requirements, such as: - Taking of medications. - Proper use of device. - Documenting adverse events and reporting to senior study staff, PI, Institutional Review Board (IRB), Sponsor, and/or any other required recipients or entities. - Ensures all data are collected and secured within approved parameters and procedures. - Ensures 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 (PI), trains staff on details of protocol, including: - Inclusion and exclusion criteria. - Informed consent procedures. - Study activities. - Source documentation and case report form (CRFs) completion. - Adverse event reporting. - Reviews and documents the dispensing and returning of study materials, such as study drugs and devices. - Acts as liaison with Sponsor’s Monitor to provide data clarifications, reviews study protocols, and ensures thorough understanding and communication. - Prepares for, participates in, and serves as liaison for scheduled Sponsor monitoring visits, such as: - 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. - Other duties as assigned. Qualifications - Bachelor's degree required or Associate's degree and completion of 6 months in the Human Subject Research Coordinator Trainee program required. - Or equivalent combination of education and experience. - Prior experience as a Phlebotomist preferred. Requirements - Word processing and data analysis software preferred. Benefits - Compensation Range: $21.36 - $29.90. - 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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