
Highly qualified Certified research professional skilled in all aspects of clinical trial coordination, protocols, and participant relationships. Experienced in both medical practice and clinical research environments. Demonstrate strong working knowledge of ICH-GCP, company standard operating procedures, regulatory guidelines, protocols and monitoring guidelines. Communicate effectively with medical personnel, colleagues, and study participants. Consistently perform at peak professionalism, adhering to code of ethics and business standards. Experienced in multiple study areas, including oncology, diabetes, hypertension, gastrointestinal, gynecology, autoimmune disorders, cardiovascular and renal. Recognized for initiative, organization, time and task management, sound problem solving skills and flexibility. Have worked with many EDC systems such as Medidata, Oracle, IBM, Trialmanager and Inform. Other platforms include Clario, ERT, Bioclinia, YPrime and Bracket. EMR experience include, EPIC, Cerner and Allscripts.
Cultivated productive relationships with patients, families, and healthcare professionals, optimizing patient progress in meeting short and long-term wellness goals.
Manage 12 Oncology trials all done remotely.
Actively engaged in professional development, deepening awareness of current developments in clinical research and healthcare.
Showed commitment to and performed consistently in high performance environment
Maintained patient/client focused approaches to work with the ability to interact professionally within a patient/client organization and provide presentations.
Possessed willingness to work in a diverse environment and value the importance of teamwork.
Maintained working knowledge of and ensured compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study specific procedures.
Creating and maintaining screen books and charts for all assigned studies
Prepare visits for the next day, ensuring accuracy of source documents and assessments
Filing of lab results, EKG results, and other communication in designated charts
Timely completion of data entry for all eCRFs, as well as paper CRF completion and transmission
Documented and conducted appropriate correspondence regarding adverse events, including multiple severe adverse events
Ensured study documents are tracked, file, maintained, and archived in audit-ready condition
Aided in the facilitation of study monitoring visits
Built relationships with investigators and site staff
Participated in Investigator and other external or internal meetings as required
Performed on-site facility inspection
Maintained working knowledge of and ensured compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study specific procedures.
Maintained compliance with required trainings in the Learning Management System (LMS/E-Learning).
Performed all tasks relevant to study participant selection, including written and oral consent, screening and educating subjects, caregivers, and referral sources on protocol specific details and expectations.
Expertly conducted full range of patient and protocol assessments, including safety and efficacy, vital signs and EKGs.
Active contributor in investigator/sponsor and coordinator meetings, sharing valuable study data and insight as requested.
Communicated professionally to internal and external study teams the performance of recruitment tactics.
Increased study engagement both with patients and site staff along with support study compliance requirements to meet sponsor goals.
Adapt to new and innovative solutions for patient recruitment challenges and fast-paced environments.
Maintenance of study regulator documents, including screening and enrollment logs, drug accountability logs, subject identification logs, site signature logs
Completion of case report forms (CRFs)
Coordinate and oversee clinical assessments of clients participating in clinical trial studies of major depression, hypertension and diabetic medications
Competent in Written and Verbal English
MSOffice Products (word, excel, power point)
Fast Learner
Adaptable
Flexible
Extreme Attention to Detail
Ability to Travel without Limitations
Strong Knowledge of Medical Terminology
Electronic Medical Records
Documentation& Reporting
Strong Work Ethic
Time Management
ICH Good Clinical Practice (GCP) | Cardiopulmonary Resuscitation (CPR) Health Insurance Portability and Accountability Act (HIPAA) | Blood Borne Pathogens Certification