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Online Resumes with " GCP"



Clinical In-house Monitoring - 4 Years of Experience

Seeking a position in a globally focused organization that will utilize my qualifications while offering several opportunities to integrate personal enrichment with professional goals.

Tags for this Online Resume: Clinical Research, ICH GCP Guidelines, Schedule Y, eCRF, EC Submission, Site coordination, Inspection, Project Coordination

Quality Engineer - 19 Years of Experience - Near 77459

SUMMARY Highly motivated, goal oriented, and efficient Quality Assurance professional with expertise in regulatory compliance, documentation, auditing, and process improvements. Known for ability to complete multi-faced tasks within strict time constraints. Demonstrated expertise in setting priorities and establishing appropriate detailed documentation to meet deadlines using strong clinical, analytical, and technical skill...

Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Audit, Complaints, ISO, ISO 9001, Management, Protocol, Manufacturing, ISO 13485

Clinical Data Management - 9 Years of Experience - Near 01821

SUMMARY * I am certified-RAVE Study Builder- Certification Sponsored by Cognizant & Medidata USA. I have 12 years of experience in Project Management, Clinical Data Management, Technical Support and Team Management,Overall 10 years of progressive experience in Clinical Data Management domain from study start up till DBL activities. I am experienced with all aspects of data management including project management, edit check...

Tags for this Online Resume: Management, Data Management, Pharmaceutical Industry, Quality, Quality Control, Team Lead, Document Management, Audit, Training, Quality Assurance

Clinical Research - 1 Years of Experience - Near 27704

A goal-driven dependable and dedicated management professional with over 12 years' solid experience in Clinical Data Management operations at a non-profit organization. Has extensive knowledge of GCP ICH and FDA regulatory requirements regarding management of clinical trials data. Expertise in data management practices for paper studies as well as electronic data capture systems. Has a proven ability to effectively communic...

Tags for this Online Resume: Data Management, Email, Management, Query, Training, Documentation, Clinical Research, Compliance, Data Entry, Project Management

Clinical In-house Monitoring - 6 Years of Experience - Near 07621

SUMMARY OF QUALIFICATIONS Pharmaceutical professional with 5+ years of clinical research experience in management and monitoring. Seeking new and exciting opportunities in new therapeutic areas to expand my expertise. Known for building strong relationships with clients and partnering with management teams to ensure quality services, compliance and efficiency. Manage Clinical Research, third party vendors, and clinical inst...

Tags for this Online Resume: Fraud, ICD-9, Insurance, Medical, Query, Management, Good Clinical Practices, ICH, Documentation, Clinical Research

Clinical Research with 7 years of experience in medical field for different positions - Near M1G 3S4

Actively looking for an opportunity to work as a Clinical Research Coordinator. Recently completed the Placement as a Clinical Research Trainee from Toronto Rehabilitation Institute (UHN), Toronto on Sep 30, 2016. Key-Skills: * Possesses Post graduate Diploma in Clinical Research with medical background and experience of working in health field for more than 7 years * Well-developed time management skills and excellent atte...

Tags for this Online Resume: Data Entry, Medical, Health Awareness, Training, Cardiopulmonary resuscitation (CPR), Clinical Research, Phlebotomy, ICH-GCP Guidelines, Pharmaceutical Industry, Patient Recruitement, Clinical Trial

Clinical Research Associate

SUMMARY: To apply my knowledge of FDA Good Clinical Practice guidelines/ICH guidelines, extensive site/field Clinical Director, Site Lead Study Management, in addition to my experience with various therapeutic areas of medicine, to a position as a Clinical Research Associate. AREAS OF EXPERTISE * Management * Interview candidates and either make a selection decision or recommend individuals for hire. * Able to manage multip...

Tags for this Online Resume: Clinical Research, Research, Accounting, Acquired Immune Deficiency Syndrome (AIDS), Advertising, Amazon Elastic MapReduce, Audit, Basic First Aid, BLS, Budgeting

Clinical Research - 2 Years of Experience - Near 77449

HIGHLIGHTS OF QUALIFICATIONS: * RN with close to 2-years experience in clinical trials monitoring * Knowledgeable of clinical trial procedures and approval processes. * In-depth knowledge of ICH GCP guidelines and FDA regulations * Conversant with Design and Review of case report forms (CRF) * Conversant with Site Monitoring visits (PSVs, SIVs, IMVs and COVs) to meet study expectations. * Clinical and post-marketing safety ...

Tags for this Online Resume: Direct Patient Care, DRESSING CHANGES, Medical, Patient Care, Suctioning, Surgical, Wound Care, Acquired Immune Deficiency Syndrome (AIDS), HIV, Monitoring

Scientist - 15 Years of Experience - Near 10583

Summary: Molecular Biologist with expertise in highly driven research environment experience ranging from writing grant proposal, MTAs with pharmaceutical companies, planning experiments, wet bench laboratory techniques, data collection, analysis, writing articles for publication in journals, preparation and presentation at National and International meetings to teaching and training students and fellows and supervising tec...

Tags for this Online Resume: Oncology, Research, Cancer, Pharmaceutical, Translation research, Medical writing, liaison, Management, Senior scientist, Clinical scientist, CRA, scientist, oncology, cancer research, medical liaison

Clinical Research

Seeking a position with a strong dynamic clinical research company in order for my skills and talents to be utilized including education, customer relations, computer applications and language skills.

Tags for this Online Resume: Clinical Research, Research Associate, GCP Guidelines, Clinical Research Associate, Medical, Medical Records, Protocol, San Antonio, Blood Glucose Monitoring, Pharmaceutical, Data Entry, Texas

Clinical Research

Summary of Qualifications Clinical Research Manager, Associate, Monitor, Coordinator, with over 25 years experience in the medical field and 21 years experience in clinical trials with extensive experience in the fields of Cardiology, Electrophysiology, Neurology, Urology, Autoimmune, Respiratory, Gastroenterology, Weight Loss, Diabetes, Women's Studies, Arthritis, COPD, Gynecology, Endocrinology, Rheumatology and Stem Cell...

Tags for this Online Resume: Monitoring, Protocol, Cardiovascular, Clinical Research, Management, Pharmaceutical, Research, Therapy, Audit, Data Management, Medical Device, CRA, CTM, Clinical Trials

Quality Assurance Director - 4 Years of Experience - Near 08736

Accomplishments: * Led a group of 6 employees in a 24-person firm * Led a group of employees and consultants to file Icotinib IND to FDA for NSCLC * Directly handled post - IND interactions/questions with FDA * Lined up Accenture to handle eCTD publishing and submissions * Led a group to assemble and file Briefing Packages to UK, Canada, Australia and Singapore Regulatory Authorities set up and presented face-to-face meetin...

Tags for this Online Resume: Regulatory Affairs, Advertising, Business Plan, Filing, Assessments, Business Development, Chemistry, Consulting, Due Diligence, Integrate