Gcp Quality Manual

Gcp Quality Manual' title='Gcp Quality Manual' />Regulatory Quality Coordinator. Job. opportunities. The South African Medical Research Council SAMRC strives to improve the nations health and quality of life by funding and conducting relevant and leading health research. It further aims to promote equity, career development and progression. The organisation prides itself on three core values being pioneering, striving for excellence and working collaboratively. Gcp Quality Manual' title='Gcp Quality Manual' />Individuals are invited to submit applications in response to the following position Regulatory Quality Coordinator. HIV Prevention Research Unit HPRU. Durban Office. One Year Contract. A committed, motivated, suitably qualified and experienced RegulatoryQuality coordinator is required to work with the Principal InvestigatorSupport Managers and Clinical Site Research Leaders in coordinating regulatory and quality aspects of HIV prevention trials. Responsibilities Implementation of systems to ensure regulatory compliance, to local and international guidelines and polices. Co ordination of all regulatory activities for all studies conducted at the HPRUTo prepare new protocol submissions for ethical and regulatory approvals. To prepare and submit progress reports to Medicines Control Council MCC and recertification with Ethics Committees. Ensuring adequate follow up on outstanding regulatory issues internally with study Principal Investigators and support mangers and externally Clinical research networks, Division of AIDS, Ethics Committees, MCC, local and international regulatoryConduct monthly regulatory review of unit studies to ensure compliance, corrective action and preventive action is completed. Integration of regulatory and quality systems to achieve data integrity and participant safety. Whether on the site or sponsor level, in clinical research we are asked to use Good Documentation Practices GDP during the conduct of a clinical trial. Research+organizations.jpg' alt='Gcp Quality Manual' title='Gcp Quality Manual' />Co ordinate Quality Management processes for all clinical components to ensure compliance with protocol and local and international guidelines. Development, implementation and evaluation of the clinical quality management plan. Supervise quality of work through sites visits, formal quality control processes, review trends from external monitoring reports, and identify areas for re training and improvement with trial Principal Investigators. Recruitment, training and mentorship of quality assurance officers Co ordinating and monitoring of staff training to ensure staff are adequately trained and competent to complete study related procedures. GCP+5.+RESPONSIBILITIES+OF+THE+SPONSOR.jpg' alt='Gcp Quality Manual' title='Gcp Quality Manual' />Training, supervision and mentorship of teams. Maintain a training database for all clinical trial staff and identify individuals who require further training. Core Requirements 4 year qualification in the medicalscientific field. Strong regulatory knowledge including GCP and HSPProficient in Microsoft office Additional Advanatages Valid GCP and HSP Certificate. Audit Checklist for Drug Industry Get an independent Part 11 Computer Systems, 210211 Drug GMPs, Part 820 Quality Systems, andor Validation TodayA Masters degree Detailed knowledge of regulatory policies, systems and requirements. Independent, meticulous attention to detail, results driven individual. Excellent verbal and written communication skills. Valid Code 0. 8 manual Drivers license. Independent work with minimum supervision. A team player with excellent interpersonal and organisational skills. Flexible, adaptable and innovative A salary in the region of R3. In accordance with the SAMRCs Employment Equity Plan, preference will be given to suitably qualified candidates from the designated groups. For this reason, we require race, gender and disability status to be specified. PLEASE QUOTE THE REFERENCE NUMBER R1. A IN ALL COMMUNICATIONS. The SAMRC retains the right not to make an appointment. Gcp Quality Manual' title='Gcp Quality Manual' />Closing date 1. November 2. Should no feedback be received within 3. Please go to the following Web Site to complete an online application. HIa. KYne. Loq. N4. 3Rd Century Edition Handbook New there. Welcome to the Institute of Clinical Research. The Institute of Clinical Research ICR is the oldest independent membership led professional body for global clinical researchers. For nearly 4. The Institute of Clinical Research ICR has provided high quality training, networking and support to the clinical research community. For many Members the Institute has been part of their life throughout their working careers, many have been with the Institute since its first incarnation as the ACRPI. It is the membership that makes the Institute. How does it all work The Institute of Clinical Research is you the Membership governed by the Articles of Memorandum drawn up by the founding members. The Board is made up of members who give their time freely to guide the future direction of the ICR. The ICR Secretariat is the administrative arm of the Institute, its primary focus is the ensure that the wishes of the Board and Membership are carried out and to see to the day to day tasks that any membership organisation generates. The ICR exists to support our members through all stages of their careers. We do this, in part, by Defining and refining standards for our profession. Providing a forum for discussion of key issues impacting clinical research. Promoting good relations with other healthcare related groups Providing opportunities for learning and development to enhance professional competence Enhancing public confidence and understanding of clinical research.