Oncology and Research are specialized and require unique skill sets. Realigning the MD Anderson Research Department at Cooper with the MD Anderson Cancer Center at Houston's recommendation, allows research growth in both the structure and the types of studies we are able to offer our clients to advance care. The role of Oncology Research Regulatory Coordinator will serve as the regulatory lead on industry-sponsored, federally funded or MD Anderson collaborative studies maintaining compliance and... more details
Oncology Research Reg Coord II
LocationUS-NJ-Camden
Job ID
19842
Category
Professionals
Shift
1
Type
Full Time
Department Name
Hematology Oncology 101 Haddon Ave
About Us
At Cooper University Health Care, our commitment to providing extraordinary health care begins with our team. Our extraordinary professionals are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols. We have a commitment to its employees by providing competitive rates and compensation, a comprehensive employee benefits programs, attractive working conditions, and the chance to build and explore a career opportunity by offering professional development.
Discover why Cooper University Health Care is the employer of choice in South Jersey.
Short Description
Oncology and Research are specialized and require unique skill sets. Realigning the MD Anderson Research Department at Cooper with the MD Anderson Cancer Center at Houston’s recommendation, allows research growth in both the structure and the types of studies we are able to offer our clients to advance care. The role of Oncology Research Regulatory Coordinator will serve as the regulatory lead on industry-sponsored, federally funded or MD Anderson collaborative studies maintaining compliance and audit readiness.
Work with sponsors during the study start-up process to prepare the regulatory documents and maintain the studies’ regulatory binders throughout duration of study through close out including version control.
Work with the Institutional Review Board to submit initial study applications, amendments, continuing reviews, adverse event reports and other submissions.
Provide regular updates to the Regulatory and Operations team members on where studies are in the review/start-up process, monitoring outcomes, and close out preparation.
Maintain the delegation of authority logs and regulatory documentation for each study and ensure study staff training on each protocol.
Work with sponsors to set up site initiation visits, monitoring visits and study close-out visits and prepare post-visit documents.
Maintains tracking for all protocol related paperwork and collects documents from sponsors for protocol submission and maintenance.
Coordinates FDA submissions and prepares for all research audits.
Experience Required
Experience
Required
Preferred
Special
Considerations
Experience
Required
Preferred
Special
Considerations
0-2 years
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6-10 years
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2-5 years
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10+ years
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Special Considerations
Explained (if needed):
Must have at least 3-5 years of related experience.
Education Requirements
Education
Required
Preferred
Special
Considerations
Education
Required
Preferred
Special
Considerations
High School / GED
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Bachelor’s Degree
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Vocational / Technical School
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Master’s Degree
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Associate’s Degree
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Doctorate Degree
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Field of Study (Please Note)
Biology, Research, Public Health, Business Administration, Healthcare Administration or related field
Special Considerations
Explained (if needed):
Refer this job to a friend
Cooper University Health Care is an Equal Opportunity Employer and is committed to equal employment opportunity for all team members. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, or any other status protected by law or regulation. To request reasonable accommodation, contact HRRecruitment@CooperHealth.eduViewApply StartCompleted
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