Delphine Ojong RNBSN

I am a highly qualified medical research specialist with expertise in all facets of clinical trial protocol development, participant connections, and trial coordination. Both clinical research and medical practice situations experience Establish a solid working understanding of the ICH-GCP, business SOPs, regulatory requirements, protocols, and monitoring standards. Effectively communicate with study participants, colleagues, and medical personnel. Maintain the highest level of professionalism while abiding by the law and corporate ethics. Clinical Trial Operations from feasibility to close-out, GDP adhering to ALCOA-C principles, and informed consent process AE and SAE identification and reporting, keeping a regulation binder with important papers, such as 1572 and DOA, but not alone. Experienced in a variety of academic fields, including psychiatry, cardiology, renal, gastrointestinal, diabetes, hypertension, and autoimmune illnesses. Given credit for initiative and organization. I am a Registered Nurse driven by the values of patient-center care, compassion, holistic care, and professional nursing practice standards. I have vast experience in the nursing care process (assessment, diagnosis, care planning, implementation, and evaluation) in multiple nursing units and care scenarios.

Certificates & Training:

Clinical Research Fastrack | TransCelerate Approved GCP Training Clinical Research Training covering Core Competencies including:

- Dangerous Goods Training

- Cardiac Life Support and AED Training

- FDA Regulations 21CFR 11, 50, 54, 56 and the Common Rule 45CFR46

- ICH GCP E6 R (2)

- Data Management

- Informed Consent Process

- Clinical Trial Operations from feasibility through close-out

- GDP following ALCOA-C principles

- Identification and reporting of AEs and SAEs

- Quality Assurance, Monitoring and AEs and SAEs and Query Resolution - Comprehension and Execution of Clinical Trial Protocols

- Maintaining a regulatory binder, housing essential documents including but not limited to 1572, DOA, Training Logs and other Investigator Site File (ISF) document

* HHA Certification

* CNA/GNA Certification

-* CPR and First aid Certification