999 Main Street.
Any Town, NY 99999
To further my career as a Clinical Research Associate.
SUMMARY OF QUALIFICATIONS
- and experienced in problem solving and providing solutions. Excellent qualifications in leadership and interpersonal communications.
- Persuasive, with ability to communicate effectively with a diverse audience. Public speaking experience.
- Knowledge of study protocols, work in accordance with Federal Regulations, Good Clinical Practices, ICH Guidelines and Standard Operating Procedures and guidance documents, excellent work ethic, strong commitment to quality patient care and a proven desire for achievement and continued professional growth.
- Skilled in training and knowledge of regulatory laws. 10+ years as Clinical Research Coordinator.
- Management of clinical trials data, formulating source documents, IRB protocol submissions IRB phases and IND Safety Reporting.
- Conduct monitoring visits for assigned protocols and study sites. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, an applicable regulatory requirements.
- Excellent organizational and problem-solving skills. In depth therapeutic and protocol knowledge as provided in company training.
Clinical Research Associate
ABC Inc. October 2008-Current
- Ensure that sites receive and maintain study drug according to the protocol.
- Perform drug accountability.
- Verify that all information concerning study vaccine identity is stored in a confidential manner.
- Provide sites training for temperature deviation and randomization programs.
- Site management for up to 3 sites at a time.
- EDC and paper CRF monitoring.
- Knowledge of ICH-GCP.
- Experience primarily with Close-out and Interim Monitoring visits, limited experience with Site Initiation and Qualification visits.
- Conduct feasibility studies.
XYZ Corp. January 2006 to October 2008
- Participate in the development and drafting of clinical trial protocols and the overall clinical .
- Participate in the identification of potential investigators and clinical sites, conducts pre-study site visits, evaluate sites and prepare feasibility reports, participate in the final selection of investigators and study sites.
- Oversee and collaborate with research, technical and, or administrative staff, including distribution of workload.
- Assist with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and study conduct tools.
- Assist the clinical investigational sites with study start up activities including ethics, regulatory submissions, initiation visits, verifies the qualifications and adequacy of site staff and resources and the availability, adequacy and functionality of all required equipment and technology.
- Monitor the conduct and progress of the studies, both on-site and remotely, to ensure compliance and Quality Assurance (QA) with established protocols, appropriate research methodology, integrity of the data, informed consent, subject confidentiality, and study time lines.
BCD Inc. June 2003-January 2006
- Examine patients and take their histories, order laboratory tests, X-rays and other diagnostic procedures and consult with other medical practitioners to evaluate patients’ physical and mental health.
- Prescribe and administer medications and treatments.
- Perform and assist in routine surgery.
- Provide emergency care.
- Provide acute care management.
- Inoculate and vaccinate patients.
- Advise patients and their families on health care including health promotion, disease, illness and accident prevention.
- Provide counseling and support to patients and their families on a wide range of health and lifestyle issues.
- Perform patient advocacy role.
- Co-ordinate or manage primary patient care.
- Provide continuous care to patients.
- home care services.
Case Western Reserve University
Bachelor of Science – Biology May 2002