A dedicated and self-motivated Clinical Research Associate with more than 5years experience in clinical trial management. Conducted all types of visits; QVs, SIVs, IMVs, COVs and monitored all clinical phases; I, II, III and IV. Effective time management skills. Work well under pressure and self-motivated with the ability to work on a team as well as independently. Excellent verbal and written communication skills. Excellent interpersonal skills. Maintain high standards for accuracy, quality and attention to detail. Excellent understanding of ICH/GCP.
Areas of Expertise
Rave and Inform
*CTMS: Impact Harmony
*Proficiency in Microsoft Word, Excel, Access, PowerPoint and Outlook, Windows iOS
Clinical Research Associate11/2011 to CurrentScope International AG. (CRO)/Excel PRSJersey, NJ
Responsible for monitoring all types of clinical trials; ensure Investigators' adequacy; adherence to Protocols, SOPs GCP, applicable regulatory requirements and compliance with all study procedures Prepare and conduct study initiation, closeout, and monitoring visits at clinical investigative sites to ensure adherence to procedures, protocols, and project plans in accordance with FDA regulations.
Review, track, and manage study documents (Case Report Forms (CRFs), Serious Adverse Event (SAE) reports, clinical notes, and enrollment logs) for accuracy and completeness, as well as query resolution.
Collects and reviews regulatory documents (1572s, Financial Disclosure Forms, CVs, Medical Licenses, etc.) for accuracy and completeness from study start-up through close-out Responsible for one or more protocols with multiple sites to ensure compliance with Good Clinical Practices (GCPs) and study procedures; including investigator selection, reviewing regulatory documents, and preparing reports while meeting timelines/milestones.
Set up the study sites ensuring each site has the staff training to trial-specific industry standards, the required clinical trial materials, and the study specific regulatory documents.
Monitor clinical studies to ensure the quality and integrity of data entered in study documents verified against source documentation on-site.
Ensure all study drug shipments and study trial supplies (used and unused) are accounted for.
Update all relevant study tracking system on an ongoing basis.
Assist Clinical Safety Manager in the collection and timely resolution of SAE reports.
Draft, compile, and verify clinical data for status reports when required.
Support compliance with study timelines.
Clinical Trial Assistant09/2009 to 11/2011Amylin Pharmaceutical IncSan Diego, CA
Accurately updated and maintained clinical systems that track site compliance and performance within project timelines Assisted the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
Assisted with periodic review of study files for accuracy and completeness Assisted with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information Assisted with the tracking and management of CRFs, queries and clinical data flow Acted as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
Tracked study budgets and payments Documenting subject study visits Coordinated, prepared for, and participated in monitoring visits, audits and inspections Maintained regulatory files, binders, and relevant protocol Interacted with sponsors, office staff, providers, and department personnel with respect to clinical trials (PI, IRB) Documented communication and study progress.
Case Manager07/2007 to 09/2009Elkhart Healthcare IncHouston, TX
Ensured patient recover and regain his or her self-care skills, helped injured or disabled individuals adapt to new work environment through conducted detailed assessment of patient's needs and coordinated with patients and other agencies to address patients' identified needs to ensure patient's goals are met.
Ensured continuity of care and medication adherence by linking patients to health insurance and pharmacy assistance programs.
Effectively engaged patients, through motivational interviewing, in positive prevention, harm reduction and healthier lifestyle choices.
Provided precise rehabilitative care; strength, mobility, balance and attention to clients Effectively documented all interactions with patients for follow up.
Advocated for both the patient and the stakeholder to facilitate positive outcome.
Residential counselor02/2006 to 07/2007AIDs AT HOMEHouston, TX
Completed all applicable assessment documents to develop individualized service plans Provided and/or assisted with direct personal care to consumers including, but not limited to; feeding, dressing, toileting, and personal hygiene, while respecting the privacy and dignity of each consumer.
Instructed and guided residents in the completion of tasks to ensure the development of skills and confidence, and monitors, evaluates and records resident's performance through written progress notes.
Monitored medication management of residents by observation and reporting medication concerns to treatment team and/or supervisor.
Assisted residents in planning recreational and educational activities.
Identified and responded to personal emergencies and crisis with referral to appropriate community resources and treatment team.
Participated in the day to day operation of the residence by assisting in meal planning and preparation, inventory, shopping and purchasing of food and household supplies, and the cleaning of the residence, while actively involving the consumer to the greatest degree possible.
Bachelor of Science (Honors): Economics Political ScienceObafemi Awolowo UniversityIle-Ife, Osun State Nigeria Economics Political Science
Central Nervous System (Depression) Phase I/Phase II (3yrs) Pain ( Lower back pain/Osteoarthritis) Phase II/Phase III (3yrs) Cardiovascular(Hypertension) Phase I/Phase III (2yrs) Respiratory (Asthma/COPD) Phase II/Phase III (2yr) Endocrinology/Metabolism (Diabetes Type 2) Phase II (4yrs) Infections Disease (HIV) Phase I/Phase II (2yrs) Dermatology (Pressure Ulcer)Phase I (18months).