Clinical Research Coordinator/ Research Assistant/

Brittany Baity

**** ******** **** ************, **. 30134

Phone: 404-***-**** E-mail: **************@*****.***

SUMMARY OF QUALIFICATIONS:

• Data Entry, Clinical Research, Data Management

• Computer proficiency in word processing, presentation, and spreadsheet applications, knowledge of Project Management processes and terminology

• Strong knowledge of medical terminology

• Excellent record keeping skills

• Attention to detail and accuracy

COMPREHENSIVE CLINICAL DEVELOPMENT 11/2009-Present

Research Coordinator

• Proficient in GCP/ICH guidelines, Patient Care and Protocol procedures.

• Prepared and submitted case report forms

• Serve as liaison between CCD Research, and CROs (as applicable) to coordinate and document clinical research studies.

• Respond to written and telephone inquiries from CRO and sponsor as applicable.

• Assist in projecting and forecasting patient project numbers.

• Develop and maintain any applicable clinical research databases as necessary.

• Responsible for site recruitment and management of clinical studies. Ensure that clinical trials are conducted in accordance with applicable standards and regulations.

• Communicate with subjects and staff regarding the planning of clinical trials, complaints, problems and general correspondence. Report on adverse events, and complaints.

• Complete necessary Clinical Evaluation Summaries and reports necessary for regulatory submissions. Serve as backup Study Coordinator and data entry

• Knowledgeable of assign clinical trial protocols, including performing subject visit, requirements, scheduling patient visits, drug accountability, ICF procedure

AMERICAN RED CROSS 10/2008 – 11/2009

Records Management Technician

• Perform Data Entry in the office databases

• Maintained Donor Records, Database Management

EMORY HOSPITAL 08/2006 – 08/2007

Research Assistant

• Data Entry, Prepared Scientific Journals, Qualitative Research

• GMP Experience; ensure GMP and EH&S compliance

• Coordinated design, relocation, GMP qualification and 5S for release of the new PCR lab space

EDUCATION:

Bachelor of Science in Biology

South Carolina State University, Orangeburg, SC

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