CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "GCP ICH"

Clinical Research Oncology

OBJECTIVE: To obtain a challenging position utilizing my medical education and research background. Continue development of experience in pharmaceutical industry that includes data coordination, statistical analyses, GCP/ICH certification, and excellent verbal and written communication skills. Application of knowledge of clinical trial designs to trial execution in a CRA or project management role

Ideal Companies: Lilly, Genentech, Quintiles, Abbott

Tags for this Online Resume: oralce, oncology, neuropharmacology biotech pharmaceutical, OBJECTIVE: To obtain a challenging position utilizing my medical education and research background. Continue development of experience in pharmaceutical industry that includes data coordination, statistical analyses, GCP/ICH certification, and excellent verbal and written communication skills. Application of knowledge of clinical trial designs to trial execution in a CRA or project management role

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

Admissions Director

Tags for this Online Resume: registered nurse, clinical research, customer service, building relationships, GCP, ICH regulatory guidelines , gastroenterology; hepatology, infectious disease, medical surgical, healthcare coaching, wellness-healthcare consultant

Clinical Research Coordinator

To join a clinical research organization as a productive team member and gain career growth while utilizing my in depth clinical research knowledge and experience.

Tags for this Online Resume: Research , Research Coordinator, GCP/ICH and FDA guidelines, Protocols, Phase

Senior Clinical Research Associate

Continue my service, as an educator and monitor in clinical trials for product development with major pharma/device company.

Tags for this Online Resume: Clinical Research Associate, GCP/ICH Guidelines, Bachelor Degree, Clinical Research Coordinator, ACLS Certification, Registered Nurse

"Clinical Research Nurse" "Drug Safety Specialist"

Career Summary Experienced professional nurse with planning and organizational skills of project activities to support investigators in the preparation and conduct of research protocols to ensure compliance in accordance to FDA, GCP and ICH requirements.

Senior Clinical Data Manager with 19 years of experience, Buffalo, NY - remote dm

Seasoned Clinical Data Manager with experience in complex projects and in managing multiple large, international clinical trials for Phases I - IV to GCP/ICH standards in biotech, pharmaceutical and non-profit venues. Ability to work within a complicated matrix environment while also independently self disciplined. Possesses solid project management skills with the ability to anticipate problems relating to projects and to ...

Tags for this Online Resume: EDC Leader, Medidata Rave, InForm, DM/Study Recovery Specialist, Mentor, Trainer

Clinical Research Project Manager-Pharma experienced-MPH-10+ years experience-GCP/ICH/FDA guidelines

Desire capstone experience integrating clinical research expertise, MPH, and medical writing. Would like to utilize adult learning theory in training/coaching role. Excited to apply critical thinking and project management skills to make a difference in patients' well-being.

Clinical Trial Professional

Detailed oriented Clinical Research Professional with medical education background and several publications. Extensive experience working on complex clinical trials in a critical care, cardiology and podiatry environment. Solid knowledge of GCP/ICH guidelines and FDA regulations. Well versed in medical terminology and medical procedures. Possess excellent communication and presentation skills.

Tags for this Online Resume: Clinical Research , Clinical Research Associate, Drug Safety Associate, Clinical Trial Associate, Research Scientist

Clinical Research Associate, seeking entry-level, in-house opportunity

I am an excellent candidate for a Clinical Research Associate position due to my unique combination of experience in Preclinical Research and Development, Pharmaceutical Sales, and CRA Training. In addition to the skills and accomplishments detailed in my c.v., please consider the following highlights: Certification from Barnett International (July 2012): 10-Week CRA & CRC Beginner Program. Coursework emphasized FDA reg...

Clinical Research Manager - RN; 15+ years experience; IRB, GCP, ICH; OHRP, FDA

provide my knowledge and expertise to help further research and compliance with federal research regulations

Tags for this Online Resume: clinical research

Regulatory Affairs, Clinical Research, Quality Assurance

A degreed professional with over 4 years of experience in the pharmaceutical/Biotech industry with multi-functional Regulatory, Clinical and Quality background. Demonstrated ability to expand beyond the scope of assigned responsibilities to gain proficiency in new areas. Responsibilities have ranged from managing the preparation, submission of INDs, BLAs, ANDAs/NDA, to reviewing QMS, essential regulatory documents to ensure...

Tags for this Online Resume: Regulatory Affairs, Clinical Research, FDA, GCP, GCP, ICH, GLP, Pharmaceuticals, Quality Assurance