I have over 4 years' experience in the Clinical Research industry as a clinical research associate/ remote monitor and as a clinical research coordinator. My therapeutic strength is in Oncology (Solid), Infections and Infectious Diseases, Gastro- intestinal tract, pulmonology and with experiences on Phases I-III.
THERAPEUTIC Experience:
Oncology-Gastrointestinal (Carcinoid syndrome) Neuroendocrine tumors, Lymphoma
GIT-Ulcerative colitis, Crohn's Disease
Pulmonology-Chronic obstructive pulmonary disease.
Infection/Infectious Diseases- Pediatric HIV/AIDS
Participated in pre-study/initiation meetings with site investigators and study coordinators to ensure complete understanding of the clinical study objectives and data requirements.
Ensured delivery of all supplies and equipment to assigned study sites.
Coordinated activities of associates and investigators to ensure compliance with protocol and overall clinical objectives.
Assisted in identifying study sites, developing feasibility questionnaires (with oversight from CSM or designee) and training documents for CRO personnel to perform pre-study visits.
Worked under close supervision of a Clinical Study Manager, monitors clinical sites to ensure adherence to protocol (including appropriate patient selection) and safety requirements.
Provided necessary study updates to Clinical Management on a regular basis.
Performed study closeout visit activities ensuring that required documents are in order.
Established and maintains working relationship with study coordinators and investigators at assigned study sites.
Ensured accuracy and completeness of the data in CRFs and resolution of data queries.
Ensured electronic CRF completion and study data entry into internal tracking systems.
Reported trends and observations noted at sites to study team.
Ensures prompt processing of drug requests.
Reviewed pharmacy drug accountability records; reviews and ensures updates to essential document/regulatory binders.
Ensures that serious adverse event (SAE) data is reported to MDS.
Ensured that Investigators have received and processed SAE information as required.
Identifies protocol modifications as needed.
Performed study tracking to ensure that all study files and documents are accurate, current and complete.
Performed essential document collection, review, and maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements, ICH/GCP guidelines and SOPs.
Provided general support to the Lead CRA and CRA in order to manage the investigator sites and ensure compliance.
Confirmed and tracked that all key site personnel have project specific training.
Documented site and sponsor contact and study interactions in a timely and professional manner.
Assisted with resolution of investigational site/data queries.
Provided quality review of the informed consent template.
Tracked submission to and approval from IRB, 1572 changes (including obtaining medical licenses and CVs related to these changes) correspondence, site changes.
11/2013 to 12/2015
Clinical Research CoordinatorSpring Clinical Research, Inc
Closely worked with various CROs in maintaining site adherence to study drug protocol, FDA regulations, ICH guidelines, Good clinical Practice (GCP) and HIPAA.
Worked together with PI to ensure that study subjects met with protocol inclusion and exclusion criteria.
Responsible for screening as well as conducting interviews with subject participants, as well as obtaining accurate medical history, demographics, vital signs, ECG, concomitant medications.
Responsible for accurate completion of Case Report Forms, Adverse Events (AE), Severe Adverse Events (SAE) and Pregnancy Forms.
Preparing Site Source documents.
Maintained timely and accurate documentation to ensure that study binders are ready for review by monitors.
Maintain Study enrollment and completion.
Ensure complete and thorough study drug accountability and reconciliation.
Worked closely with site monitors on Site Initiation, Interim and Close-out monitoring visits.
Acquired specific clinical and therapeutic knowledge related to each specific study.
Query resolutions, daily communications with CROs, Site monitors, PI and other study coordinators.
Dispenses study drug as per protocol.
Instructs patients on study procedures and visit schedules.
Maintains study kits and equipment.
Drawing, preparing and shipping all labs per protocol requirements.
Coordinates with study labs regarding patient lab results, lab kit procurement.
Obtained Informed consent from subjects.
Other types of data entry into the EDC (RAVE/MEDIDATA, DataLabs, Oracle/Inform).
02/2012 to 07/2015
Pharmacy TechnicianWalmart Central Fill Pharmacy － Spring Hill, TX.
01/1999 to 07/2010
Medical OfficerUniversity of Abuja Teaching hospital
NIH clinical Research Training- September, 2016
* ICH-Good Clinical Practices-September, 2016.
* NIH protecting- Human Research participants' course September 2016.
*CRO/Sponsor Specific SOP
*EDC System training
*CTMS Training (IMPACT)
