Research Regulatory Coordinator
Behavioral Health Market Context
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Benefits
We have a commitment to our employees to provide competitive rates and compensation programsCooper offers full and part-time employees a comprehensive benefits program, including health, dental, vision, life, disability, and retirementWe also provide attractive working conditions and opportunities for career growth through professional development
Job Description
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 our employees to provide competitive rates and compensation programs. Cooper offers full and part-time employees a comprehensive benefits program, including health, dental, vision, life, disability, and retirement. We also provide attractive working conditions and opportunities for career growth through 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 regulatory demands of managing the study portfolio requires a lead position in order to oversee regulatory operations and train new staff members.
Oversees regulatory operations for MD Anderson Cancer Center at Cooper
Supervisory/Management:
2.1 Participates in the management of the departmental regulatory coordinator and regulatory research assistant staff.
2.2 Completes Supervisory skills series offered by Cooper.
2.3 Works with the Director of Oncology Research Administration to assign studies to staff and monitors compliance of staff to standards, policies and quality measures.
2.4 Coordinates and participates in the interview and selection process.
Manages the cooperative group/federally funded studies including DTLs and regulatory documents
Trains new regulatory staff members
Receive and organize the initial regulatory documents for cooperative group studies
Corresponds directly with sponsors/CTSU via email and by phone
Communicates with colleagues and providers to give updates on study start up for each protocol
Experience Required
3-5 Years Required
Must have at least 3-5 years of experience. More than 5 years of experience strongly preferred.
Experience in clinical research administration that may include regulatory or project management.
Education Requirements
BACHELOR'S Degree Required
Biology, Research, Public Health, Business Administration, Healthcare Administration or related field
License/Certification Requirements
Clinical Research Certification
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 our employees to provide competitive rates and compensation programs. Cooper offers full and part-time employees a comprehensive benefits program, including health, dental, vision, life, disability, and retirement. We also provide attractive working conditions and opportunities for career growth through 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 regulatory demands of managing the study portfolio requires a lead position in order to oversee regulatory operations and train new staff members.
Oversees regulatory operations for MD Anderson Cancer Center at Cooper
Supervisory/Management:
2.1 Participates in the management of the departmental regulatory coordinator and regulatory research assistant staff.
2.2 Completes Supervisory skills series offered by Cooper.
2.3 Works with the Director of Oncology Research Administration to assign studies to staff and monitors compliance of staff to standards, policies and quality measures.
2.4 Coordinates and participates in the interview and selection process.
Manages the cooperative group/federally funded studies including DTLs and regulatory documents
Trains new regulatory staff members
Receive and organize the initial regulatory documents for cooperative group studies
Corresponds directly with sponsors/CTSU via email and by phone
Communicates with colleagues and providers to give updates on study start up for each protocol
Experience Required
3-5 Years Required
Must have at least 3-5 years of experience. More than 5 years of experience strongly preferred.
Experience in clinical research administration that may include regulatory or project management.
Education Requirements
BACHELOR'S Degree Required
Biology, Research, Public Health, Business Administration, Healthcare Administration or related field
License/Certification Requirements
Clinical Research Certification
Qualifications
- •3-5 Years Required
- •Must have at least 3-5 years of experience
- •Experience in clinical research administration that may include regulatory or project management
- •BACHELOR'S Degree Required
- •Biology, Research, Public Health, Business Administration, Healthcare Administration or related field
- •Clinical Research Certification
Responsibilities
- •The regulatory demands of managing the study portfolio requires a lead position in order to oversee regulatory operations and train new staff members
- •Oversees regulatory operations for MD Anderson Cancer Center at Cooper
- •2.1 Participates in the management of the departmental regulatory coordinator and regulatory research assistant staff
- •2.2 Completes Supervisory skills series offered by Cooper
- •2.3 Works with the Director of Oncology Research Administration to assign studies to staff and monitors compliance of staff to standards, policies and quality measures
- •2.4 Coordinates and participates in the interview and selection process
- •Manages the cooperative group/federally funded studies including DTLs and regulatory documents
- •Trains new regulatory staff members
- •Receive and organize the initial regulatory documents for cooperative group studies
- •Corresponds directly with sponsors/CTSU via email and by phone
- •Communicates with colleagues and providers to give updates on study start up for each protocol
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