Grade\: T25
The link below will give you information about the University’s “T”
salary structure.
Learn more about the “T” salary structure.
A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant’s education and experience, all relevant internal equity considerations, department budget, and funding source.
Summary\:
As a key member of the PCORI Team, a Clinical Research Coordinator’s work directly contributes to innovative research and implementation strategies that prioritize patient-centered care. From study start-up to closeout, the Clinical Research Coordinator will collaborate with a diverse team of healthcare professionals and researchers to drive meaningful change in our healthcare delivery systems.
Under the direction of the Director, CRORA and Clinical Investigators, the Clinical Research Coordinator will be responsible for managing the day-to-day activities of a PCORI funding Pediatric Antimicrobial stewardship implementation project as well as supporting one or more departments in the Lewis Katz School of Medicine at Temple University. Primary responsibilities include establish and maintain databases of subjects; schedule and conduct study visits; collect and enter data into the eDC; register subjects and study visits in OnCore; maintain an up-to-date regulatory binder; schedule and attend sponsor visits; and prepare and submit IRB paperwork to ensure compliance with IRB regulations. Incumbent will support multiple active protocols simultaneously, and working with multiple investigators while adhering with FDA, IRB, Pennsylvania, and related regulations.
The Clinical Research Coordinator works closely with investigators, healthcare professionals, and the project manager to ensure the successful implementation and completion of research protocols
**Travel between Philadelphia area practice locations by car or public transportation is required.**
Essential Functions\:
· Assist the PM in coordinating all research study phases, from start-up to close-out.
· Assist with study timeline management, ensuring key milestones are met.
· Maintain communication with the Principal Investigator (PI), Project Manager, and regulatory authorities.
· Coordinate with clinic sites across the health system
· Screen, recruit, and enroll for Focus groups.
· Obtain informed consent from participants, ensuring they understand study procedures and risks.
· Monitor participant follow-up and maintain high levels of engagement to reduce dropout rates.
· Prepare and submit Institutional Review Board (IRB) applications and amendments.
· Ensure adherence to Good Clinical Practice (GCP) guidelines, FDA regulations, and local regulatory requirements.
· Maintain accurate, up-to-date study records, including source documents and regulatory binders.
· Collect, process, and record data related to the study in accordance with the protocol.
· Perform quality control checks on collected data to ensure accuracy and completeness.
· Ensure the secure storage of confidential participant information.
· Facilitate meetings, communication, and reporting among study teams.
· Periodically requires travel to practice locations by car or public transportation.
· Create and disseminate reports of findings to stakeholders and funders
· Demonstrate proficient knowledge of OnCore CTMS, Epic Research, and Florence eBinders or comparable programs used within the department.
· Assist with grant or manuscript preparation and maintenance of investigator-initiated studies registered on clinicaltrials.gov
· Complete required billing review and reconciliation
· Performs other duties as assigned
Benefits of working at Temple University include\:
Great Benefit package
Generous time off
Parental Leave
Tuition Remission
Dynamic Workforce
Click here to learn more about the benefits of working at Temple University.
Required Education & Experience\:
Bachelor's degree in life science or health professions field and at least three years of directly related clinical research coordinator experience. An equivalent combination of education and experience may be considered.
Required Skills & Abilities\:
*Strong eDC data entry skills.
*Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, sponsors, and research participants.
*Ability to operate all standard office equipment/software, including MS Office.
*Ability to work independently or as a team with excellent attention to detail and adherence to project deadlines.
*Knowledge of FDA, IRB, Pennsylvania, and related regulations.
*Ability to travel between practice locations
Preferred\:
*Prior experience with IRB submissions, both local and central.
*Prior experience processing and shipping biological samples a plus
*Prior phlebotomy certification or willing to learn a plus
*Prior experience with OnCore CTMS, Epic Research, and Florence eBinders
This position requires a background check.
This position requires Child Abuse Certifications prior to the commencement of service.
This is a grant-funded position.
Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information, or veteran status.
Compliance Statement\: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact.
To obtain additional information about Temple University, please visit our website at www.temple.edu.
Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. Click here.
You may request a copy of the report by calling Temple University’s Campus Safety Services at 215-204-7900.
*
Grade\: T25
The link below will give you information about the University’s “T”
salary structure.
Learn more about the “T” salary structure.
A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant’s education and experience, all relevant internal equity considerations, department budget, and funding source.
Summary\:
As a key member of the PCORI Team, a Clinical Research Coordinator’s work directly contributes to innovative research and implementation strategies that prioritize patient-centered care. From study start-up to closeout, the Clinical Research Coordinator will collaborate with a diverse team of healthcare professionals and researchers to drive meaningful change in our healthcare delivery systems.
Under the direction of the Director, CRORA and Clinical Investigators, the Clinical Research Coordinator will be responsible for managing the day-to-day activities of a PCORI funding Pediatric Antimicrobial stewardship implementation project as well as supporting one or more departments in the Lewis Katz School of Medicine at Temple University. Primary responsibilities include establish and maintain databases of subjects; schedule and conduct study visits; collect and enter data into the eDC; register subjects and study visits in OnCore; maintain an up-to-date regulatory binder; schedule and attend sponsor visits; and prepare and submit IRB paperwork to ensure compliance with IRB regulations. Incumbent will support multiple active protocols simultaneously, and working with multiple investigators while adhering with FDA, IRB, Pennsylvania, and related regulations.
The Clinical Research Coordinator works closely with investigators, healthcare professionals, and the project manager to ensure the successful implementation and completion of research protocols
**Travel between Philadelphia area practice locations by car or public transportation is required.**
Essential Functions\:
· Assist the PM in coordinating all research study phases, from start-up to close-out.
· Assist with study timeline management, ensuring key milestones are met.
· Maintain communication with the Principal Investigator (PI), Project Manager, and regulatory authorities.
· Coordinate with clinic sites across the health system
· Screen, recruit, and enroll for Focus groups.
· Obtain informed consent from participants, ensuring they understand study procedures and risks.
· Monitor participant follow-up and maintain high levels of engagement to reduce dropout rates.
· Prepare and submit Institutional Review Board (IRB) applications and amendments.
· Ensure adherence to Good Clinical Practice (GCP) guidelines, FDA regulations, and local regulatory requirements.
· Maintain accurate, up-to-date study records, including source documents and regulatory binders.
· Collect, process, and record data related to the study in accordance with the protocol.
· Perform quality control checks on collected data to ensure accuracy and completeness.
· Ensure the secure storage of confidential participant information.
· Facilitate meetings, communication, and reporting among study teams.
· Periodically requires travel to practice locations by car or public transportation.
· Create and disseminate reports of findings to stakeholders and funders
· Demonstrate proficient knowledge of OnCore CTMS, Epic Research, and Florence eBinders or comparable programs used within the department.
· Assist with grant or manuscript preparation and maintenance of investigator-initiated studies registered on clinicaltrials.gov
· Complete required billing review and reconciliation
· Performs other duties as assigned
Benefits of working at Temple University include\:
Great Benefit package
Generous time off
Parental Leave
Tuition Remission
Dynamic Workforce
Click here to learn more about the benefits of working at Temple University.
Required Education & Experience\:
Bachelor's degree in life science or health professions field and at least three years of directly related clinical research coordinator experience. An equivalent combination of education and experience may be considered.
Required Skills & Abilities\:
*Strong eDC data entry skills.
*Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, sponsors, and research participants.
*Ability to operate all standard office equipment/software, including MS Office.
*Ability to work independently or as a team with excellent attention to detail and adherence to project deadlines.
*Knowledge of FDA, IRB, Pennsylvania, and related regulations.
*Ability to travel between practice locations
Preferred\:
*Prior experience with IRB submissions, both local and central.
*Prior experience processing and shipping biological samples a plus
*Prior phlebotomy certification or willing to learn a plus
*Prior experience with OnCore CTMS, Epic Research, and Florence eBinders
This position requires a background check.
This position requires Child Abuse Certifications prior to the commencement of service.
This is a grant-funded position.
Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information, or veteran status.
Compliance Statement\: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact.
To obtain additional information about Temple University, please visit our website at www.temple.edu.
Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. Click here.
You may request a copy of the report by calling Temple University’s Campus Safety Services at 215-204-7900.