- Develop and revise compliance programs, policies, and procedures related to human research protections, research review processes, Investigational New Drug (IND), Investigational Device Exemption (IDE) proposals, and investigational products under the purview of the FDA, RAC, and OBA.
- Liaise with external entities including government regulatory authorities and agencies, and coordinate audits and site visits for external regulatory agencies.
- Act as a project leader for assigned projects related to regulatory submissions, and assist in the drafting, assembly, review, and revision of IND/IDEs and other regulatory applications for review committees (e.g., CT-SRC, IRB, IMC, DSMB, etc.).
- Resolve issues/inquiries/deficiency letters with regulatory and follow up to ensure initial applications are approvable.
- Assist with the administration of the regulatory research compliance plan.
- Identify risk areas and assist in developing quality assurance auditing, monitoring, and oversight processes in line with regulatory requirements and institutional policies.
- Provide ongoing feedback to clinical research investigators and teams to support compliance.
- Assist with the planning, development, and implementation of training and education programs related to regulatory/ compliance/quality assurance.
- Perform other duties as assigned to meet the goals and objectives of the department and institution.
- Maintains regular and predictable attendance.
- Bachelor's degree in relevant area required.
- Minimum Requirement: 4+ years of experience in related field (e.g., quality, regulatory affairs, human research protection program compliance, or policymaking in government or pharma industry)
- Proven performance in earlier role.
- Applicable certification preferred (e.g., Society of Clinical Research Associates (SoCRA), Association of Clinical Research Professionals (ACRP), Certified IRB Professional (CIP), Regulatory Affairs Certification (RAC), Certified Healthcare Research Compliance (CHRC))
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Sr Clinical Trials Registration Specialist - Memphis, United States - St. Jude Children's Research Hospital
Description
Sr Clinical Trial Registration Specialist
Manages day-to-day operations and system applications associated with Clinical (CTG) and NCI's Clinical Trial Reporting Program (CTRP) reporting and/or monitoring for all St. Jude Children's Research Hospital trials. Utilizes clinical research and project management expertise to work with Investigators, Sub-Investigators and Statisticians to monitor the timely analysis and reporting ofresults to CTG and CTRP. Reviews new clinical research protocols, drafts study registrations, documents objectives and determines data reporting timelines and documents changes during the life cycle of the study.
Evaluates and maintains data systems and determines requirements for the development of internal and external systems to satisfy reporting requirements. Trains and advises faculty and staff in the requirements of CTG and CTRP reporting programs. Maintains an awareness and understanding of regulatory changes, technological advances, clinical and research processes and clinical research conduct.
Job Responsibilities:
Minimum Education and/or Training:
Minimum Experience:
Licensure, Registration and/or Certification Required by SJCRH Only:
Compensation
In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $78,000 - $139,360 per year for the role of Sr Clinical Trials Registration Specialist.Explore our exceptional benefits
Diversity, Equity and Inclusion
St. Jude Childrens Research Hospital has a diverse, global patient population and workforce, built on the principles of diversity, equity and inclusion. Our founder Danny Thomas envisioned a hospital that would treat children of the worldregardless of race, religion or a familys ability to pay. Learn more about our history and commitment.
Today, we continue the mission to advance cures and means of prevention for pediatric catastrophic diseases through research and treatment. As we accelerate this progress globally, we believe our legacy of diversity, equity and inclusion is foundational to success. With the commitment of leaders at all levels of the organization, we strive to ensure the St. Jude culture, leadership approaches and talent processes are equitable and culturally responsive. View our Diversity, Equity and Inclusion Report to learn about the hospitals roots in diversity, equity and inclusion, where we are today and our aspirations for an even better future.
St. Jude is an Equal Opportunity Employer
No Search Firms
St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.
