Emory University Clinical Trials Regulatory Specialist in atlanta, Georgia

Description

JOB DESCRIPTION:

  • Supports clinical research team (physicians, nurses, etc.) 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.

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

  • Manages identified issues and provides feedback to leadership regarding resolution.

  • Disseminates information and participates in training.

  • Provides direction and feedback to research team to ensure awareness of business practices and quality standards.

  • Documents any exceptions to compliance standards. Manages new submissions and continuing review activities.

  • Reviews initial submissions to determine review category and action to be taken.

  • 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.

  • Serves as lead contact for each assigned trial, maintains records and corresponds with all parties involved (institutional, federal, pharmaceutical).

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

  • Attends research team meetings to report on regulatory issues.

  • Responsible for administrative duties corresponding to budgets and contracts.

  • Performs related responsibilities as required.

MINIMUM QUALIFICATIONS:

  • Bachelor's degree and two years of experience in a research environment, 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.

  • THIS IS A PART-TIME (ESTIMATED 6-9 MONTHS) POSITION

PREFERRED QUALIFICATIONS:

Experience managing regulatory requirements for NIMH and/or Industry sponsored clinical trials required (e.g. Conducting data quality assurance reviews for monitor visits, maintaining regulatory binders and submitting IRB submissions). Experience as Clinical Research Coordinator is beneficial.

ADDITIONAL JOB DETAILS:

The successful candidate will assist the Department of Psychiatry’s Behavioral Immunology Program team with conducting NIMH and investigator funded clinical research on the role of inflammation on mood, behavior and cognitive function. Candidate will function as an integral research team member. Excellent communication and organizational skills are required.

Additional Details

--78023BR

Apply Now

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.

Connect With Us!

Not ready to apply?

Job Number 15205

Job Type Temporary Part-Time

Division School Of Medicine

Department SOM: Psych: Adult

This position may involve the following Health and Safety issues: Not Applicable

Job Category Laboratory

Emory University is an equal opportunity/equal access/affirmative action employer fully committed to achieving a diverse workforce and complies with all applicable Federal and Georgia State laws, regulations, and executive orders regarding nondiscrimination and affirmative action in its programs and activities. Emory University does not discriminate on the basis of race, color, religion, ethnic or national origin, gender, genetic information, age, disability, sexual orientation, gender identity, gender expression, and veteran's status. Inquiries about this statement should be directed to the Office of Equity and Inclusion, 201 Dowman Drive, Administration Bldg, Atlanta, GA 30322