
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
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
Delivered comprehensive, compassionate patient care, including testing and evaluation, medication administration, progress monitoring, and treatment planning.
Increased Patient compliance with office visits and medication by 55%.
Educated community members and patients on disease prevention, diet, and hygiene.
Trained, supervised and evaluated healthcare providers, nursing, and office staff, ensuring quality and integrity of practice and patient service.
Managed office staff on patient retention and rapport.
Encouraged complete routine administrative task and patient services in a timely manner.
Cultivated productive relationships with patients, families, and healthcare professionals, optimizing patient progress in meeting short and long-term wellness goals.
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.
Competent in Written and Verbal English
MS Office 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