Clinical Research Regulatory Coordinator
Job Details
The Sidney Kimmel Comprehensive Cancer Center (SKCCC) is seeking candidates for an entry-level Clinical Research Regulatory Coordinator position. This regulatory coordinator will provide regulatory support for National Clinical Trials Network (NCTN) studies. The position reports to a Regulatory Manager within the Research Support Services of the Clinical Trials Office.
The Regulatory Coordinator is responsible for the accurate compilation and submission of protocols and related study documents to the Protocol Review and Monitoring Committee (PRMC) and applicable Institutional Review Board (IRB), and for maintaining regulatory study files to ensure all protocols and essential regulatory documents are current and complete.
Job Description
Primary Responsibilities
The ideal candidate will have a bachelor’s degree or higher in a scientific or healthcare-related field and at least 1 year of experience working in the clinical research field. Additional qualifications include:
Soft skills
Organized: The ability to prioritize and manage many pending tasks.
Communicates effective: Clear and timely in responses and requests.
Flexibility: Makes adjustments as needed.
Problem-Solving/ Critical thinking: Uses resources and guidance to find solutions, including problems that arise outside regular workflow.
Team Mindset: Shares challenges and solutions to enhance team strength.
Initiative: Takes initiative to efficiently address issues or present new solutions.
Self-motivated: Performs with minimal need for prompting.
Hard skills
Comfortable with technology, hardware and software
Familiarity with MS Office, internet, and email.
Exposure to research methods and procedures
Access to dedicated home workspace free of distractions and reliable internet service.
This position is 100% remote. Candidates must reside in an approved state (PA, NJ and DE) where Jefferson is authorized to employ staff.
Work Shift
Workday Day (United States of America)
Worker Sub Type
Regular
Employee Entity
Thomas Jefferson University
Primary Location Address
1015 Chestnut Street, Philadelphia, Pennsylvania, United States of America
Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years.
Jefferson is committed to providing equal educational and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status.
Benefits
Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance.
For more benefits information, please click here
The Sidney Kimmel Comprehensive Cancer Center (SKCCC) is seeking candidates for an entry-level Clinical Research Regulatory Coordinator position. This regulatory coordinator will provide regulatory support for National Clinical Trials Network (NCTN) studies. The position reports to a Regulatory Manager within the Research Support Services of the Clinical Trials Office.
The Regulatory Coordinator is responsible for the accurate compilation and submission of protocols and related study documents to the Protocol Review and Monitoring Committee (PRMC) and applicable Institutional Review Board (IRB), and for maintaining regulatory study files to ensure all protocols and essential regulatory documents are current and complete.
Job Description
Primary Responsibilities
- Serves as the primary regulatory contact for assigned protocols.
- Maintains the regulatory binders and investigator site files.
- Coordinates submissions to ancillary committees as required.
- Communicates with the IRB and Sponsor on behalf of the study team regarding regulatory management.
- Collaborates with the study team and sponsors to finalize documents based on PRMC and/or IRB recommendations.
- Prepares and submits study amendments and continuing review applications for PRMC and IRB review.
- Prepares regulatory files for auditing and QAE reviews.
The ideal candidate will have a bachelor’s degree or higher in a scientific or healthcare-related field and at least 1 year of experience working in the clinical research field. Additional qualifications include:
Soft skills
Organized: The ability to prioritize and manage many pending tasks.
Communicates effective: Clear and timely in responses and requests.
Flexibility: Makes adjustments as needed.
Problem-Solving/ Critical thinking: Uses resources and guidance to find solutions, including problems that arise outside regular workflow.
Team Mindset: Shares challenges and solutions to enhance team strength.
Initiative: Takes initiative to efficiently address issues or present new solutions.
Self-motivated: Performs with minimal need for prompting.
Hard skills
Comfortable with technology, hardware and software
Familiarity with MS Office, internet, and email.
Exposure to research methods and procedures
Access to dedicated home workspace free of distractions and reliable internet service.
This position is 100% remote. Candidates must reside in an approved state (PA, NJ and DE) where Jefferson is authorized to employ staff.
Work Shift
Workday Day (United States of America)
Worker Sub Type
Regular
Employee Entity
Thomas Jefferson University
Primary Location Address
1015 Chestnut Street, Philadelphia, Pennsylvania, United States of America
Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years.
Jefferson is committed to providing equal educational and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status.
Benefits
Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance.
For more benefits information, please click here