Education

Education

Functiona Areas of Expertise

Skills

Regulatory Affairs and Safety:

  • Ensure all trials are conducted and completed in a timely and accurate manner in accordance with FDA, ICH, and GCP guidelines.
  • Provide support and timely follow-up for all audit and quality assurance activities.
  • Create and update study documents (i.e. 1572, ICFs, assents, HIPAA, etc) to ensure regulatory compliance.

Study Development and Startup Startup:

  • Facilitate Pre-study, Initiation, Interim and Closeout visits.
  • Conduct Phase I, II, and III clinical trials.
  • Coordinate upfront logistics to ensure all site specific details and processes are in place for study initiation.
  • Collaborate with IT to create protocol specific eCRFs
  • Review and revise PRAs for all need studies. Negotiate budgetary amendments related to participant travel and compensation when necessary. 

Documentation and Reporting:

  • Ensure adverse events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary.
  • Review and verify CRF, Informed Consent Documents and query language/narratives for accuracy.
  • Serve as a liaison and maintain required communication with regulatory agencies within institution and sponsor.
  • Prepare regulatory submissions and supporting documents for IRB review and Sponsor records.

Clinical Training:

  • Acquire specific clinical and therapeutic knowledge related to studies monitored.
  • Interface with patients to determine study candidacy and conduct consenting process accordingly.
  • Assist with recruitment tool development and implementation to increase study enrollment and retention
  • Reconcile source documents with electronic database for sponsor access.
  • Assist in the review and development of department standard operating procedures.
  • Train backup associate on study protocol.

Work History

Work History
May 2015 - Present

Clinical Research Coordinator III, Infectious Disease

Emory University Hope Clinic, Atlanta, Georgia

Clinical research coordinator for VTEU, DMID, HVTN, VRC, HIPC VAX studies as well as internal “Emory” physician originating studies. Independently manages significant and key aspects of large clinical trials. Oversees data management, interfaces with research participants, determines effective strategies for promoting/recruiting/retaining research participants in long term clinical trials, periodically audit operations including laboratory procedures to ensure compliance with applicable regulations; provides leadership in identifying and implementing corrective actions/processes. Interfaces with study sponsors, monitors and reports SAEs; resolves study queries. Provide leadership in determining, recommending, and implementing improvements to policies/processes.

Jul 2012 - May 2015

Clinical Research Lead IV, Breast/GYN Cancer

Emory University, Winship Cancer Institute, Atlanta, Georgia

Independently manages significant and key aspects of a large clinical trial or all aspects of one or more small trials. Trains and provides guidance to less experienced staff. Oversees data management for research projects. Interfaces with research participants and resolves issues related to study protocols. Authorizes purchases for supplies and equipment maintenance. Determines effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. Periodically audits operations including laboratory procedures to ensure compliance with applicable regulations; provides leadership in identifying and implementing corrective actions/processes. Monitors IRB submissions and responds to requests and questions. Interfaces with study sponsors, monitors and reports SAEs; resolves study queries. Provides leadership in determining, recommending, and implementing improvements to policies/processes. Assists in developing grant proposals and protocols. Performs related responsibilities as required.

Jul 2010 - May 2015

Clinical Research Coordinator (PRN starting 2012)

Children's Healthcare of Atlanta

Dynamic, results-oriented Clinical Research Assistant with experience in coordinating and regulatory services for key support roles in clinical research. Possesses a broad based knowledge of FDA regulations as well as ICH/GCP guidelines. Facilitates the flow of information between principal investigators, study sponsors, and IRB. Exhibits exceptional interpersonal skills and work ethic. Ensure the timely and accurate conduct of clinical trials in accordance with FDA, ICH, and GCP guidelines. Responsible for IRB submissions, i.e. protocol changes, ICF amendments, continuing renewal, and other relevant regulatory requirements for more than 200 IRB studies

Aug 2009 - Jun 2010

Clinical Research Coordinator I

University of Kentucky, Lexington, Kentucky

Monitor and coordinate clinical trial activities to ensure that it is recorded, conducted and reported in accordance with standard operating procedures, protocol, GCP/ICH, and relevant regulatory requirements.

Certifications

Certifications
Dec 2011 - Present

Certified Clinical Research Coordinator (CCRC)

Society of Clinical Research Associates SoCRA
2006

Human Subject Protection and HIPAA Certified

Collaborative Institutional Training Initiative (CITI)
2009 - Present

Basic Life Support (BLS) Certified

American Heart Association

Professional Presentations

Mosley, R. (2015). Breast Cancer Screening in Georgia Among African Americans 50-60 Years Old:A Multi-level Analysis to Reduce Breast Cancer Mortality, Emory University, Rollins School of Public Health

Mosley, R. (2015).First Food Deserts: Exploring Community Impact to Breastfeeding, Emory University, Rollins School of Public Health

Mosley, R. (2015).Tough Talks to Tender Hearts: A program Evaluation, Rollins School of Public Health

Mosley, R. (2015). Breast Cancer Clinical Trials: Grady Updates, Emory University, Annual Winship Cancer Institute Retreat