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Online Resumes with "Serious Adverse Event "
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.
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
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
SUMMARY OF QUALIFICATIONS • Foreign graduate Medical Doctor and licensed RN with more than 22 years of clinical and research experience. US citizen. Fluent in English, Russian and Romanian • Extensive training in Good Clinical Practices, ICH Guidelines, SOPs through various Sponsors • In depth therapeutic and protocol knowledge as per Sponsor’s assignment. Excellent organizational and problem-solving skills.
Ideal Companies: Biotech companies
I am seeking for a stable and well established company that is growing. Also,what I am looking for in a new job is for employers that care about their employees and acknowleges them for their good hard work. I would also hope that good training is provided so that the individual such as myself can be productive for the company and contribute towards it's success rate. I would also hope that it was a warm welcoming environm...
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
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...
Pharmaceutical Deputy Compliance/Internal Auditor/Governance/Risk Management/Internal Controls/Change Management
I am interested in a position where I can leverage the skills and experience I have gained over a career in the pharmaceutical industry.I am a skilled professional with over 15 years experience in compliance, risk management, corporate governance and change management, as well as R&D internal audit and assurance. I am an excellent communicator, with well-developed speaking and writing skills and in-depth subject matter e...
Tags for this Online Resume: Internal audit, Training, Risk Management, Governance, Internal Control, Change Management, Risk Assessment, Facilitation, External Benchmarking, Communication through writing, Thought Leader, Team Player, Project Leader, Business Liaison, Contract Analyst, Assurance, Risk Profiles, Compliance
• 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...
• 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...
Experienced Clinical Research Professional interested in positions within the pharmaceutical or medical device industry.