Clinical Research Associate Clinical Research Associate. Conduct of Bioavailability and Bioequivalence Studies 1. Preparation of ICF. 2. Accountability & storage of Investigational drug product. 3. Recruitment & Registration of volunteer. 4. Obtaining ICF from volunteer for screening and study. 5. To maintain volunteer screening log. 6. Dispensing of IP as per randomization schedule. 7. Check-in/ check-out of volunteer. 8. Administration of Investigational drug product. 9. Preparation of labels for blood collection tubes, plasma separation vials & dispensing containers. 10. Centrifugation, separation and storage of plasma sample. 11. Issuance of plasma sample to bioanalytical department. 12. Data entry into CRF & compilation of trial master file. 13. To provide necessary support for Report preparation. 14. Review and updating SOPs. }( read more).....

Senior Manager Clinical Outsourcing - Perform and manage the budget development, payment terms and negotiation activities associated with the development and execution of Contract Research Organization (CRO) contracts - Work with the clinical groups in coordinating the information necessary to develop RFP s for projects to be outsourced (RFP budget creation and analysis) - Manage the financial component of the RFP review process through vendor selection and contract finalization - Assist vendor management with financial performance monitoring and metrics ? Participate in clinical working group meetings on a needed basis to receive and provide information and advice on contractual and budgetary issues - Update tracking system with all vendor/agreement/budget information - Point of contact to the CROs in resolving contract budget issues. }( read more).....

Clinical Investigators Qualifications: MBBS with 2-4 Years of ICU Experience Skillsets: Volunteer Screening and Selection Subject monitoring during the study Adverse event reporting Emergency support/subject safety Incharge of ICU }( read more).....

Clinical Project Manager Accelovance is an innovative niche CRO focused on accelerating vaccine and drug advancement. We conduct Phase II through Phase IV clinical trials. Our clients are pharmaceutical and biotech companies. Excellent ground floor opportunity that includes salary, bonus and stock options. Accelovance is currently seeking qualified individuals with relevant expertise for the position of Clinical Project Manager. }( read more).....

Associate Director, Clinical Regulatory Strategic Planning Plan and consult global clinical trial IND's, NDA's and other projects for one of the worlds largest and most dynamic Contract Research Organizations - Kendle. The Associate Director Clinical Regulatory Strategic Planning is responsible for the regulatory and business leadership and establishing its mission and goals. This responsibility includes close working relationships with members of the Global Regulatory Affairs Operating Unit, other Kendle Operating Units and clients. The Director is responsible for maintaining the quality and consistency of the group's service to clients. The Director is responsible for the day to day functioning of the unit and its development both as an integral part of Kendle and a profit center for the Kendle organization. CORE RESPONSIBILITIES ·Accountable for the day to day running of the US Regulatory Affairs Consulting group, ensuring quality and having the ultimate responsibility for all projects undertaken by the group. ·Develop and execute short and long-term business and marketing strategies for in order to develop new business as well as maintaining current customers. ·Work closely with New Business Development by preparing, bid information, presentations to clients and attending client meetings. ·Influence overall objectives of the regulatory function worldwide and on regulatory aspects of the clinical function. ·Act as a company resource for advice on regulatory, technical and industry knowledge for key clients and projects. ·Act as point of contact for clients, regulatory authorities and senior managers within the Kendle organization. ·Responsible for identification of external sources of expertise and arranging collaboration as necessary to facilitate effective completion of projects. ·Has US Medical Writing as a reporting function. ·Develop, review and approve budget. ·Develop performance standards for the groups and evaluate performance. ·Interpret and communicate company policy within a group. ·Develops and maintains the vision of the company in coordination with Kendle Senior Management. ·Provide mentoring/training to regulatory staff within Kendle or training globally as required. ·Participate and provide leadership as needed for Kendle training programs. ·Responsible for identification of external sources of expertise and arranging collaboration as necessary to facilitate effective completion of projects. }( read more).....

Good Laboratory Practices for Pre-Clinical Testing This two-day course is designed for all Scientists (managerial and laboratory), Regulatory Affairs and Compliance personnel who are active in pre-clinical studies. It will be of most benefit to professionals whose job function necessitates the generation, evaluation, assurance and submission of data from pre-clinical studies. Principal Investigators, Study Directors, Study Monitors and professionals aspiring to these positions will derive benefit from the course. This course will provide participants with a comprehensive understanding of the terminology, regulations and mandated practices for GLP testing and compliance. Those attending will get a thorough briefing of the relevance of accurate documentation, calibration and maintenance of instruments and validation of relevant methodology. Special attention will be paid to the critical compliance aspects of gathering pre-clinical data in a regulated environment. ( read more).....

How to Monitor Clinical Trials for GCP Compliance This training course provides a solid understanding of GCP requirements and clinical quality assurance overviews for clinical trials. Attendees will learn proven techniques for detecting, correcting and preventing clinical study deficiencies at domestic and international clinical sites. This course teaches participants how to ensure that their data and supporting documentation are completely accurate, factual and in the appropriate format for company and regulatory authorities. Included in the course work are practical examples and a roadmap for evaluating SOPs, consent forms, investigator brochures and source documents through presentation and interactive case studies. Anyone involved in the oversight or facilitation of clinical trials will benefit from this course. ( read more).....

Good Clinical Practices (GCPs) This course is designed for Clinical Research Monitors (CRMs), Clinical Research Auditors and others who need basic and expanded knowledge in FDA and ICH Regulations for Good Clinical Practices (GCPs). This three-day program will provide attendees with the training needed to improve clinical trials and ensure compliance with Good Clinical Practice, FDA Regulations, EU Directives and ICH Guidelines. Participants will receive an in-depth understanding of the clinical research process, the roles and responsibilities of key players and regulatory requirements.( read more).....

Effective Clinical Data Acceptance Testing This intense 90-minute accredited online course focuses on isolating and cleaning data issues to assure that correct, consistent and reliable analysis data sets are reproducible. Discussions will focus on proven techniques to address real-world issues. Get your SAS technical and validation questions answered and learn efficient tips for accepting and locking the clinical study data base in a timely manner. Selected edit check macros and acceptance testing guide are included in the course. Module 1: Analysis of Clinical Data Issues:  Identifying and quantifying the impact of bad clinical data  Establishing protocol criteria for clinical data acceptance testing  Checking for data compliance at all three levels: general, CDISC domain, and study protocol specific Module 2: Effective Methods and SAS Macros to Identify Data Issues:  Developing and testing edit check macros  Applying standard edit check macro parameters Module 3: Communicating and Monitoring Improvements in Clinical Data Issues:  Timely and effective communication of results with Clinical Data Management  Managing metrics on clinical data acceptance testing for quicker data base lock Question and Answer Session ( read more).....

24th Annual DIA DATA Conference and Exhibition: CLINICAL DATA LIFECYCLE Trial Design through Submission and Beyond Multitrack Conference to Discuss Standards, Processes, and Infrastructure across the Clinical Data Lifecycle Learn the latest information in processing across the clinical data lifecycle, end-to-end, from trial design through submission, particularly focused on standards-based, metadata-driven approaches. Sessions and presentations will focus on:  Efficiency, streamlined processes, and improved quality through the implementation of standards-based, metadata-driven processing across the clinical data lifecycle  Case studies that address the challenges of data integration across the clinical data lifecycle  Tools and processes required to build an appropriate foundation for implementing standards-based, metadata-driven processing across the clinical data lifecycle Special Features  Senior management roundtable and panel discussions in each of the tracks  Keynote Address and an FDA Update Session in a Plenary Town Hall format. ( read more).....