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Adept at data management and fostering investigator relations, I significantly enhanced clinical trial efficiency and compliance at IQVIA. My expertise in regulatory documentation and organizational capabilities led to a marked improvement in study outcomes, with a focus on achieving results through meticulous attention to detail and proactive problem-solving. Detail-oriented Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives. Hardworking CRA successfully leads site evaluations, initiations and closeouts. Well-versed in different therapeutic trials and of picks up new procedures quickly. Offering advanced planning, problem-solving and communication skills developed over 12+ years of clinical research success. Knowledgeable CRA is adept at recognizing clinical values and abstract data from source documents. Uses analytical skills to identify data or patient safety issues. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.

Dynamic and results-driven Senior Clinical Research Associate (SrCRA) with over nine years of experience in the clinical trials field. Specialized in conducting trials for various diseases, particularly in the fields of oncology, pulmonology, and cardiology. Experienced in the process of site selection for sponsors. Since 2022, I have been working in Poland, currently holding the position of Senior CRA at ICON Strategic Solutions. In June 2024, I successfully passed the state exam for knowledge of the Polish language for foreigners (level B1). Proficient in performing all types of visits, including selection, initiation, routine, and close-out. I am fluent in Ukrainian (native), Russian (fluent), and proficient in English (intermediate). Well-acquainted with the principles of Good Clinical Practice and regulatory documents (ICH-GCP, GLP, GMP), which form the basis of any clinical trial. I hold a valid ICH-GCP certification until 2027. Experienced in using the following systems: CTMS, EDC (Medidata, eCaseLink), eTMF (Veeva v1.0 and V2.0, PhlexEview), IXRS (4G Prancer, Endpoint, Almac, S-Clinica), and IRT (Suvoda).
Skills: Clinical Trials Implementation and Monitoring Investigational Site, Management Data Verification and Accuracy Team Leadership and Mentoring Regulatory Compliance (ICH-GCP, GLP, GMP), Strategic Planning and Coordination.

 Knowledgeable Clinical Trial Manager with seasoned experience as a Senior CRA and Senior Site Manager for several global sponsors and CRO organizations. Successful trial outcomes have been accomplished with 100+ start-up, 150+ initiation, 200+ maintenance and 100+ close-out visits conducted, along with feasibility and pre-study visits. Years of experience originated from a foundation of a CCRC to understanding project management practices and tools within small, mid-size, large CROs and sponsors. Involvement in multi-therapeutic areas of phase II-IV clinical trials has provided oncology, rare disease, immune disorders, ophthalmology, vaccines and observational study experiences in pediatric and adult environments. These environments led to knowledge, experience and leadership over the years and provided support. Responsibility held in quality management of clinical programs and budgets within risk-based monitoring approach using e-source, EDC, regulatory and IRT platforms. Adherence to strict compliance of FDA regulations and ICH/GCP guidelines, combined with sponsor SOPs led to project management skills and trial leadership, while working in a CRA atmosphere for many years. Remote office environment using relevant tools and effective communication with various computer software and clinical research platforms led to understanding “daily activities” of project management practices. Successful clinical research protocols require knowledge of clinical trial design, planning and organizational skill. Various communication software has developed computer literacy. 

Results-driven clinical research associate with a proven track record of delivering high-quality work and achieving company goals. Recognized for exceptional communication and teamwork skills, contributing to efficient project execution. Proficient in data capture procedures and data collection, coupled with strong organisational abilities that enhance productivity. Committed to continuous learning and professional development.

Detail-oriented Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives.

Denise Camara

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Senior Clinical Research Associate

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Certificate - Clinical Research

Bachelor Of Science - Biology

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Senior Clinical Research Associate

Certificate - Clinical Research

Bachelor Of Science - Biology

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