CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "Serious adverse events"

Senior/Lead Clinical Research Associate

Seasoned Clinical Research Professional with 10+ years experience in Clinical Research, including, CRA, Lead CRA, and Project Management duties. THerapeutic areas include oncology, endocrine/metabolism, and CNS.

Ideal Companies: biotech, pharma

Tags for this Online Resume: clinical trials manager, oncology, clinical research

Have the experience and the knowledge of the clinical trial processes (start-up through close-out), including FDA regulations

Social/Clinical Trials Research Assistant/Coordinator/Clinical Support Specialist

Tags for this Online Resume: ICH Guidelines, IND Application, Guidance on HIPAA Privacy in Research, Protocol Amendment, Quality Assurance (QA), Serious Adverse Events (SAE) or Serious Adverse Drug Reaction (serious ADR), Source Document, Randomization

CTA

Seeking for a challenging career in a progressive organization offering the opportunity for contributing my skills services to the organization and personal growth and to work sincerely with maximum effort using best talents and with a challenge to achieve required goals and targets, abiding to the decisions of seniors and to earn a good reputation what ever required.

Tags for this Online Resume:  Develop, maintain and manage appropriate study documentation,  Developing, writing and presenting the clinical trial protocols,  Initiate, maintain and reconcile Trial Master File.,  Monitoring the trial throughout its duration which will involve visiting the Study centers on a regular basis to check the patient data in the case report forms (CRFs) and to sort out any problems which may arise.,  Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other Data collection tools by careful source document review Monitor data for missing of implausible data.,  Complete Serious Adverse Event (SAE) reporting, process production of Reports, narratives and follow up of SAEs and managing the clinical data intermilitently as per 21CFR USFDA guidelines,  Monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines.,  Independently perform CRF review; query generation and resolution against established data review guidelines on client data management systems as assigned Perform other duties as assigned by management., , maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned

Agricultural Technician

Tags for this Online Resume: Drug Safety Associate , Serious Adverse Event , Argus , Safety reviewer, MedWatch , CIOMS

Clinical Research Associate and QA with 1 year experience and M.Sc. in Science with 10 years' experience

To get a position as a Clinical Research Professional and involve in Canada pharmaceutical industry.

Tags for this Online Resume: ICH/GCP guidelines, FDA requirements , Design and revised protocol, Standard Operating Procedure , Case Report Form (CRF), Informed Consent Form (ICF), Adverse Events (AE) and Serious Adverse Events (SAE) , Data Managemnet, MS office, Phlebotomy, CPR, Recruit subjects

Senior Manager with 12 years experience in drug safety and human resource management

Accomplished leader in drug safety and project management; experienced author of standard procedures in accordance with internal and regulatory requirements; pharmacovigilence and nursing leadership with progressive line management responsibilities; proficient in serious adverse event reporting and reconciliation, safety databases; understanding of Pharmacovigilance quality methodologies and infrastructure; nursing experie...

Director - 7 Years of Experience - Near 46229

• Self-motivated with progressive experience in coordinating activities with the Joint Commission, Department of Child Services, CMS full-scale surveys; understands regulatory communication, plan of corrections, and follow up. • Planned, staffed, implemented, prioritized, controlled, evaluated projects, and coordinated task levels to complete projects within deadlines. • Strong organization and project management skills wit...

Tags for this Online Resume: Performance Improvement, Risk Management, CPHQ, Quality healthcare, Project Management

Clinical Research - 20 Years of Experience - Near 33406

• Clinical Research Consultant with over 28 years of Pharmaceutical/Biotech experience including Phase I – III clinical trial development with direct involvement in multiple FDA/ICH submissions leading to six NDA approvals. • Extensive monitoring domestically and internationally, training and mentoring innumerable CRAs/Monitors in the field which lead to further training responsibilities with Study Teams and Management Te...

Tags for this Online Resume: Florida, Pharmaceutical Research, Monitoring, Management, Team Building