Clinical Research Associate

Experienced Clinical Trials coordinator within diverse therapeutic areas. Versed in Maintenance, accurate documentation, data entry, electronic health record (EHR). Clinical support, Conducting Trial Start-up and close-out, Coordinate CRA visits and source data matches and clearing queries in a timely manner. Inspection and audit readiness and Good Source documentation. Smart learner; attentive to details, always hit the ground running and take minimal time to acclimate and perform. Always calmed and focused in critical circumstances.

Skills: FDA and regulations, Institutional Review Board (IRB), Investigator Site File (ISF), Design CRF, Creating Datasets, Medical terminology, Project Management, Data Management, Epidemiology and Biostatistics, Regulatory and Medical Writing, Clinical Trial Budgeting, HIPAA, SOP, Protocols, CTA, Budgeting, Attention to details, AE/SAE Reporting, ICH and GCP Guidelines.

Technology: Proficient in MS Office Tools, EMR, Inform, Rave, J-review, Oracle Clinical, CTMS, Data Management System, SAS Programming, EDC, Web Design and Computer Programming, IVRS

THERAPEUTIC EXPERIENCE:

Cardiovascular: Essential Hypertension, Heart Failure-Mediated Familial Amyloidotic Cardiomyopathy, Pacemaker, Life Vest.

Endocrinology: Diabetes Mellitus

Infectious Disease: HIV/AIDS, Ebola Virus, Cholera, Malaria in sub-Saharan Africa

Work Experience

Laurelton Heart Specialist, Rosedale NY Jan 2016 - Present

Clinical Trial Coordinator

Performed initial and continue review submissions to the appropriate IRB

Implemented strategies to keep track ICF, protocol updates from IRB sites.

Reviewed SUSARS reports from sponsors and reports to the PI.

Designed case report forms using Oracle clinical program

Reported all AEs and SAEs to the Safety team.

Submitted Protocol deviations and SAEs to the IRB, Sponsor and FDA.

Updated SOP and Trial Master File.

Participated during study start-up and close out visits.

Carefully explained and obtained Consent from study subjects.

Bargained Clinical Trial Budget with the sponsor and CRO.

Negotiated Clinical Trial Agreements on behalf of sponsor.

Fulfilled sponsor requirements related to reportable information, including: adverse events, unanticipated problems, other information required by the sponsor protocol.

Responded to queries on a timely basis.

Recruited subjects as per study inclusion and exclusion criteria.

Conducted study visits per protocol and enter data in the EDC in a timely fashion.

Developed subject retention strategies and share with sponsor.

Attended Investigational Meetings on behalf of the Investigator.

HOPE PARMA HOSPITAL, Cameroon 11/2013 – 03/2015

Clinical Research Coordinator

Participated on HIV/AIDS sensitization campaign to the public and join team in HIV testing

Explained protocol to the subjects, obtain consent and screening patients into the study.

Ensured Good Clinical Practice procedures to ensure integrity and disease prevention.

Sensitized the community about recent health concerns during the outbreak of the Ebola Virus/Cholera

Distributed mosquito tents to families to prevent the spread of Malaria disease

Performed basic clinical evaluations: including blood pressure, pulse, EKGs, phlebotomy, review current and changes to medications, document adverse events.

Provided administrative support to the project team.

Maintained the study-specific Trial Master File and associated electronic archives

Counseled patients on the importance of taking medication and being healthy

Monitored patients’ wards and reports to the physician about patients with depressing circumstances

Ensured patients’ rooms and wards are clean every morning before the physician starts routine.

EMOTECH ENTERPRISE, LLC, Buea, Cameroon 09/2012 – 10/2013

Project Manager

Developed and interpreted organizational goals, policies, and procedures.

Trained internship students and held conference and training seminars

Consulted with users, management, vendors, and technicians to assess computing needs and system requirements.

Developed and interpreted organizational goals, policies, and procedures.

Trained internship students and held conference and training seminars

Consulted with users, management, vendors, and technicians to assess computing needs.

Certifications: GCP/ICH, Certified CRP/AED, Registered Medical Assistant, Clinical Trial Management Certificate, (NIH certified)Protecting Human Research Participants.

Membership: ACRP member since 2017

Education

Advanced Clinical Trial Management certificate - Sollers Inc, New Jersey Dec, 2016

Registered Medical Assistant Certificate - Allen School of Health Sciences-New York Jan, 2016

B.Sc Management & computer science - University of Buea-Cameroon 2013

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