Human Subject Research Spec I
Rochester, New York
Employer: University of Rochester
Industry: Facilities Support
Salary: $21.36 - $29.90 per hour
Job type: Full-Time
Opening
Full Time 40 hours Range URG 106 Geri Onc M&D
Schedule
8 AM-4:30 PM
Responsibilities
GENERAL PURPOSE:
Coordinates the activities associated with human subject research.
JOB DUTIES AND RESPONSIBILITIES:
1. 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.
2. 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. May participate in developing recruitment strategies. May conduct telephone interviews to screen potential study candidates. Reviews medical chart history with Principal Investigator to verify inclusion criteria are met before enrollment.
3. Conducts visits to ensure research participant adherence with protocol requirements, such as taking of medications, proper use of device, and/or other interventional activities, to document adverse events and report 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.
4. 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, and adverse event reporting.
5. Reviews and documents the dispensing and returning of study materials, such as study drugs and devices. Ensures additional training is provided to ensure changes to protocol and documents are communicated and adhered to.
6. 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).
7. 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.
8. Other duties as assigned.
QUALIFICATIONS:
Bachelor's degree required. No experience required or equivalent combination of education and experience (for example, an Associate¿s degree and completion of 6 months in the Human Subject Research Coordinator Trainee program). 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: $21.36 - $29.90 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.
Full Time 40 hours Range URG 106 Geri Onc M&D
Schedule
8 AM-4:30 PM
Responsibilities
GENERAL PURPOSE:
Coordinates the activities associated with human subject research.
JOB DUTIES AND RESPONSIBILITIES:
1. 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.
2. 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. May participate in developing recruitment strategies. May conduct telephone interviews to screen potential study candidates. Reviews medical chart history with Principal Investigator to verify inclusion criteria are met before enrollment.
3. Conducts visits to ensure research participant adherence with protocol requirements, such as taking of medications, proper use of device, and/or other interventional activities, to document adverse events and report 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.
4. 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, and adverse event reporting.
5. Reviews and documents the dispensing and returning of study materials, such as study drugs and devices. Ensures additional training is provided to ensure changes to protocol and documents are communicated and adhered to.
6. 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).
7. 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.
8. Other duties as assigned.
QUALIFICATIONS:
Bachelor's degree required. No experience required or equivalent combination of education and experience (for example, an Associate¿s degree and completion of 6 months in the Human Subject Research Coordinator Trainee program). 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: $21.36 - $29.90 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.
Created: 2024-08-31
Reference: 254349
Country: United States
State: New York
City: Rochester
ZIP: 14608
Similar jobs:
-
Clinical Nutrition Spec 1, Transplant
University of Rochester in Rochester, New York💸 $59280 - $77085 per year -
Sr Spec, Central Sales
L-3 Technologies in Rochester, New York💸 $73500 - $136500. per year -
IUOE Maintenance Spec, Data Ctr
University of Rochester in Rochester, New York💸 $36.31 per hour -
Associate Director, Mental Health Svcs. (Approved Spec.) LvI - Addiction Consult Services, MPA Behavioral Health *Grant Funded*
NYC Health Hospitals in New York, New York -
Physician Support Spec
University of Rochester in Rochester, New York💸 $19.47 - $25.77 per hour -
Spec Medictn Financial Crd III - Pharmacy Supply Chain
University of Rochester in Rochester, New York💸 $19.08 - $25.77 per hour -
Lead Clinical Research Spec
University of Rochester in Rochester, New York💸 $63815 - $95723 per year -
Sr Business Development Spec
University of Rochester in Rochester, New York💸 $77216 - $115824 per year -
Lead Research Program Spec
University of Rochester in Rochester, New York💸 $77216 - $115824 per year -
Health Info Mgmt Spec L I
NYC Health Hospitals in New York, New York -
Sr Equity & Inclusion Prog Spec
University of Rochester in Rochester, New York💸 $70197 - $105295 per year -
Clinical Research Data Spec I
University of Rochester in Rochester, New York💸 $21.36 - $29.90 per hour -
IUOE Maintenance Spec, Data Ctr
University of Rochester in Rochester, New York💸 $36.31 per hour -
Sr Organizational Develp Spec
University of Rochester in Rochester, New York💸 $70197 - $105295 per year -
Med Technologist-Spec
University of Rochester in Rochester, New York💸 $47.93 per hour -
Spec Medictn Financial Crd III
University of Rochester in Rochester, New York💸 $19.08 - $25.77 per hour -
Clinical Research Data Spec I
University of Rochester in Rochester, New York💸 $21.36 - $29.90 per hour -
Sr Human Subject Research Spec
University of Rochester in Rochester, New York💸 $60431 - $84603 per year -
Med Technologist Spec, CoreLab
University of Rochester in Rochester, New York💸 $47.93 per hour -
Clinical Research Spec II
University of Rochester in Rochester, New York💸 $51810 - $72534 per year