Research Study Coordinator III- Quality (Auditing) - Cancer Clinical & Translational Research - 4...
Henry Ford Health System
Behavioral Health Market Context
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Job Description
esearch experience, 2 years of research project management experience, a strong knowledge of GCP and federal regulations, and research certification (SOCRA or ACRP). A clinical background, cancer clinical research experience, and audit or monitoring experience are preferred.
This team member will perform routine monitoring of investigator-initiated trials, routine and for-cause internal audits of cooperative group and pharmaceutical trials with a special focus on research protocol adherence by all CCTRO team members, and audit preparation for cooperative group and pharmaceutical sponsored trials. The position requires strong organizational skills and attention to detail, and excellent verbal and written communication skills.
GENERAL SUMMARY:
Under minimal supervision, the Research Study Coordinator III is responsible for coordinating research projects within guides of regulatory compliance and/or Code of Federal Regulation.
• Provides technical support to Principal Investigators.
• Duties include but not limited to, interacting with both internal and external customers at all levels and oversight of recruitment and coordinating day-to-day operations of the study.
• Direct contact with potential and enrolled study participants expected. Provides other support as required.
• May work on multiple studies at any given time.
EDUCATION REQUIRED:
• Bachelor's degree in a scientific field, Psychology, Sociology, Anthropology, or related field.
EXPERIENCE REQUIRED:
• Three (3) years of relevant experience with at least two (2) years of research project coordination experience.
CERTIFICATIONS/LICENSURES REQUIRED:
• SOCRA or ACRP and IATA certification required.
This team member will perform routine monitoring of investigator-initiated trials, routine and for-cause internal audits of cooperative group and pharmaceutical trials with a special focus on research protocol adherence by all CCTRO team members, and audit preparation for cooperative group and pharmaceutical sponsored trials. The position requires strong organizational skills and attention to detail, and excellent verbal and written communication skills.
GENERAL SUMMARY:
Under minimal supervision, the Research Study Coordinator III is responsible for coordinating research projects within guides of regulatory compliance and/or Code of Federal Regulation.
• Provides technical support to Principal Investigators.
• Duties include but not limited to, interacting with both internal and external customers at all levels and oversight of recruitment and coordinating day-to-day operations of the study.
• Direct contact with potential and enrolled study participants expected. Provides other support as required.
• May work on multiple studies at any given time.
EDUCATION REQUIRED:
• Bachelor's degree in a scientific field, Psychology, Sociology, Anthropology, or related field.
EXPERIENCE REQUIRED:
• Three (3) years of relevant experience with at least two (2) years of research project coordination experience.
CERTIFICATIONS/LICENSURES REQUIRED:
• SOCRA or ACRP and IATA certification required.
Qualifications
- •The candidate should have 3 years of relevant research experience, 2 years of research project management experience, a strong knowledge of GCP and federal regulations, and research certification (SOCRA or ACRP)
- •May work on multiple studies at any given time
- •Bachelor's degree in a scientific field, Psychology, Sociology, Anthropology, or related field
- •Three (3) years of relevant experience with at least two (2) years of research project coordination experience
- •SOCRA or ACRP and IATA certification required
Benefits
Responsibilities
- •The CCTRO is seeking an experience research study coordinator quality auditor who will join the CCTRO quality team and assist the team with clinical trial quality assurance and quality control activities including study auditing and monitoring as primary responsibilities but will also include coverage of staff training and education responsibilities
- •This team member will perform routine monitoring of investigator-initiated trials, routine and for-cause internal audits of cooperative group and pharmaceutical trials with a special focus on research protocol adherence by all CCTRO team members, and audit preparation for cooperative group and pharmaceutical sponsored trials
- •The position requires strong organizational skills and attention to detail, and excellent verbal and written communication skills
- •Under minimal supervision, the Research Study Coordinator III is responsible for coordinating research projects within guides of regulatory compliance and/or Code of Federal Regulation
- •Provides technical support to Principal Investigators
- •Duties include but not limited to, interacting with both internal and external customers at all levels and oversight of recruitment and coordinating day-to-day operations of the study
- •Direct contact with potential and enrolled study participants expected
- •Provides other support as required
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