Clinical Trials Regulatory Specialist

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Description:
The Hope Clinic of the Emory Vaccine Center is an international Center of Excellence in clinical and translational research in infectious diseases vaccines, treatment, and prevention. The mission of the Hope Clinic is to conduct human research studies and clinical trials for infectious diseases of public health importance. The clinical studies encompass vaccines, treatments, prevention, community-based research, and laboratory-based translational human immunology.

The Clinical Trials Regulatory Specialist I is an entry-level position supporting regulatory affairs in clinical trial research. The primary focus of the position is to collaborate with the multiple IRBs, sponsoring companies, and site Project Managers to ensure study documents receive committee approval and are made available to the site in a timely manner. This position will oversee pre-submission to governing agencies, and provide foundational information for more complex regulatory work. Incumbents in this job classification may be primarily focused on non-interventional studies, with a relatively small trial portfolio.

KEY RESPONSIBILITIES:

Assists regulatory team (Regulatory Specialist II and III) in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects.

Supports processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations.

Responsible for study completion processes including data lock, study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports and assuring archival of appropriate/required documentation.

Develops, maintains, utilizes, and updates all internal and external protocols, data collection sheets, spreadsheets, and databases for use in gathering and compiling information specific to each research process.

Knowledgeable of the safety reporting requirements of the study protocol, FDA and other regulatory bodies.

In a timely fashion, monitors, detects and reports adverse events meeting requirements of regulatory bodies.

Coordinates activities and gathers information from a variety of sources to achieve stated outcomes.

Completes and maintains regulatory documents for all study personnel, including curriculum vitae, license, bio-sketches, financial disclosures, Form FDA 1572, confidentiality agreements, and delegation of duties logs.

Performs protocol activation and assist investigators with NCI Registration and Credential Repository (RCR) tasks (i.e. new and renewals) Reviews initial submissions to determine review category and action to be taken.

Compiles and maintains eRegulatory Binders Completes submission applications, and other required documentation, prepares protocol specific forms for submission to various review committees, including internal scientific review boards, the IRB and sponsoring entities.

Supports the Assistant Director, Operations Manager, and Regulatory Coordinators II/III in Program Research in the day-to-day activities of regulatory safety management for patients enrolled on research protocols.

Completes protocol renewal applications, amendment applications and maintains record of all adverse event reports.

Attends research team meetings to report on regulatory issues.

With department administration, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports to investigators, department administration and funding agencies.

Performs related responsibilities as required.

Additional Quality Management Duties to include:

Provides clinical trials Quality Management (QM) and follows established QM processes to support compliance with applicable regulations.

Conducts a variety of QM activities intended to facilitate and assure that clinical trials comply with the requirements of the approved study protocol, the approving Institutional Review Board, Emory University and applicable Food and Drug Administration (FDA) and other regulatory requirements.

Conducts QM activities in accordance with established procedures.

Utilizes appropriate QM checklists and report templates to record and report QM findings.

Documents QM activities in writing, using appropriate report formats and communicates such findings to the appropriate parties (clinical trials management, the principal investigator, and designated members of the regulatory and clinical trials staff).

Reviews the accuracy, completeness, and timeliness of completed study related records, case report forms and other documents.

Compares reported data with original source documents.

Reviews study related processes relative to applicable regulatory requirements, including the FDA's GCP regulations and departmental guidelines.

Verifies the following items for clinical trials: protocol compliance (i.e. subject recruitment and eligibility criteria and informed consent procedures); that only designated investigator(s) and/or appropriate clinical research staff are performing clinical trial functions; that regulatory compliance is being maintained (i.e. that investigators are providing and maintaining all study related documents as required).

Promptly communicates any serious deficiencies noted during QM to the appropriate parties.

Works cooperatively with clinical research staff and investigators to address their concerns and to communicate findings that can lead to improved clinical trial performance and/or compliance.

Maintains a record of all correspondence, QM reports and other written documentation in accordance with operating procedures.

Participates in meetings and in-service training activities.

Maintains in strict confidence all confidential information regarding clinical trials and clinical research study sponsors.

MINIMUM QUALIFICATIONS:

Bachelor's degree, or an equivalent combination of experience, education and training.

Knowledge of clinical research practices.

Must complete all required training courses within one month of hiring date.

NOTE: Position tasks are required to be performed in-person at an Emory University location; working remote is not an option. Emory reserves the right to change this status with notice to employee.

Emory Supports a Diverse and Inclusive Culture:
Emory University is dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, gender, genetic information, age, disability, sexual orientation, gender identity, gender expression, and veteran's status. Emory University does not discriminate in admissions, educational programs, or employment on the basis of any factor stated above or prohibited under applicable law. Students, faculty, and staff are assured of participation in University programs and in the use of facilities without such discrimination. Emory University complies with Executive Order 11246, as amended, Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity and affirmative action. Emory University is committed to achieving a diverse workforce through application of its affirmative action, equal opportunity and nondiscrimination policy in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Inquiries regarding this policy should be directed to the Emory University Department of Equity and Inclusion, 201 Dowman Drive, Administration Building, Atlanta, GA 30322.

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