He resigned in 2006, to start a new company called Bakubung Clinical Research Services. Module 2: Advanced GCP Workshop. pursued from a recognized university. Up until now these requirements have been available only via direct feedback such as via stakeholder meetings, but they do now appear in the upcoming SA GCP 2019 guidelines (still in draft but hopefully finalized before the end of 2019). Q: Is ICH GCP training or […], Comments Off on GCP Refresher Online Course, Our GCP online refresher course is live! Therefore, most SA GCP training is valid as ICH GCP certification elsewhere in the world, but the reverse is not true. She has a masters degree in clinical research administration from the George Washington University, USA and an Honours degree in nursing. ACRO has a Level 2 BBBEE rating. GCP/ICH. We also have a GCP refresher course available online (ERECCA). Our free GCP training can also serve as a refresher course. The Centre currently presents basic and refresher GCP training to all researchers in the Western Cape. What […], Comments Off on GCP Beginner Webinar Course, CREDE’s GCP Beginner Webinar Course is an exciting innovation for changing times We are diversifying our range of GCP courses to include a live webinar GCP beginner course during extenuating circumstances where face to face courses are not possible. We are focused on the clinical research environment in South Africa and the rest of Africa. He has recently completed his training and is now a certified clinical research associate (CRA) at Quintiles, a Fortune 500 company with over 36 000 employees in more than 100 countries. The MRC regularly posts job opportunities, at the moment advertising for an office manager, clinical manager, and scientific writer. Masoom Clinical Research is a South African based Clinical Research Organisation (CRO).. Masoom Clinical Research offers the full range of CRO services including Phase I-IV services, clinical trial management, monitoring, patient recruitment, quality assurance, regulatory affairs, medical writing, data management and biostatistics.. Do a broad search of our available courses using an individual filter, or a more refined search on multiple filters. Good Clinical Practice (GCP) training is manadated for all research staff participating in clinical trials. Though it's just a general job website, Indeed.co.za lists many research jobs in south Africa and is a good place to sstart. When the facilitator is dynamic and the course material is well designed GCP becomes alive and the training is both meaningful and fun. It can be completed all at once or you can return and resume as many times as you need […], What is research but a blind date with knowledge. He then joined Sanofi-Synthelabo South Africa in 2002 as Clinical Operations Manager, to setup a South African clinical research unit. Advocate | Educate | Mentor | Monitor. Each member of the team must be in possession of a valid, recognised GCP certificate. A: SA regulations require that the Beginner or Basic GCP course must be in person face to face (this is a 2 day course). Our programmes are grounded in wide experience in the field and expert content knowledge. Every 3 years you need to do a GCP Refresher course (face to face or online). The current training available to our active investigators covers a variety of topics related to Good Clinical Practice (GCP). Module 4: Foundation Course in Clinical Research and GCP for Investigators. South Africa today is the richest and most economically developed country in the continent. or Degree in Science, Pharmacology, Pharmacy, Life Sciences, Biotechnology etc. Our localized expertise in the regulatory requirements of the different countries, along with strong site relationships – allows us to proactively … GCP training certification is required to be re-newed on a 3-yearly basis. Medpace has partnered with Sponsors to set up and manage clinical trials in Africa for more than a decade. Download an information sheet on the online course (click here) Who is this course aimed at? A: No! Did you know that the National Health Act (no 61 of 2003) makes compliance with the South African (SA) Good Clinical Practice (GCP) guidelines compulsory when doing any research involving human subjects?. With a local team based in Johannesburg, Medpace South Africa has conducted multiple studies in a variety of different indications across the region. Below are actively recruiting clinical trials for South Africa. A: If you’ve never done GCP training before you have to attend a Beginner 2 day face to face training. If your previous certification has lapsed by more than 3 months (i.e. Yes, even GCP can be fun! Discuss and understanding the use of acronyms in the section of "The language of Clinical Research" Provide an explanation and background surrounding the history of human experiments and development of Principles of Good clinical practice principles as outlined in the ICH-GCP guidelines and South Africa Good Clinical Practice guidelines. We are focused on the clinical research environment in South Africa and the rest of Africa. This course is based on the international E6 ICH Good Clinical Practice regulations and is a complete training solution for all individuals that need to acquire GCP knowledge. Watch video on YouTube For information on South Africa's response to COVID-19 please visit the COVID-19 Corona Virus South African Resource Portal . The Clinical Research Centre (CRC) invites you to view a brand-new video tour of our facilities. The purpose of the Summit was to Is this training valid? The package contains beautifully designed, interactive presentations that … Diploma in Clinical Research is a 1-year full-time course. A: Ethics Committees and the South African Health Products Regulatory Authority (SAHPRA) draw up the requirements together with the National Health Research Ethics Council (NHREC). The core program includes 7 general ICH/FDA GCP modules, with 2 optional modules for sites in South Africa (module 8) and for training … Yes! A professional organisation to promote excellence in clinical trials and clinical research in South Africa. The curriculum must incorporate both local and international guideline requirements. Other professionals who want to enter the field of clinical research, or who have been hired recently by academic study sites and need comprehensive training in clinical research. The Centre for Medical Ethics and Law (previously known as the Bioethics Unit) has been presenting Good Clinical Practices courses since 2003. A PROPOSED MODEL FOR CLINICAL NURSING EDUCATION AND TRAINING IN SOUTH AFRICA The Nursing Education Stakeholders (NES) Group CPAS, DENOSA, FUNDISA, NEA, Nurse Managers, PHEPSA, SANC Abstract The Department of Health hosted a Nursing Summit in April 2011. more than 3 years and 3 months ago) you need to redo the Beginner course. CREDE (Clinical Research, Education, and Development) is an independent organization that provides GCP and other clinical research training, education and development. ACRO offers services to donor-funded organisations, non governmental organisations, research … One of the earliest and original CRO’s located in Africa, it is now well able to conduct clinical trials all over the African continent. The Refresher GCP course however, may be done face to face or online if the course is accredited and is based on SA GCP. TRANSFORMING IDEAS INTO SOLUTIONS ACRO (African Clinical Research Organisation) is the first South African, full-service, black economic empowerment, contract research organisation. You will learn about Good Clinical Practices and how it influences country specific regulations, the drug development process and the phases of clinical research and post-marketing research, which are the parties responsible in clinical trials, and what are the qualifications, background, training and experience a clinical research professional needs to have. Clinical Courses Find your ideal course using the filters below. Study coordinators, investigators, research nurses, project managers, managers, and any person in the clinical research team who is involved in the planning or implementation of recruitment and retention of participants. For those who prefer online learning over our legendary face to face GCP Refresher Course, we have developed an exciting new course: The whole course can be completed online. About this course. A: Yes, anyone who is part of a clinical research team in any capacity needs to be GCP certified. A good SA GCP course will cover the overlapping content and refer to ICH GCP as well. Our training sessions are unique because they are fun, customized, topical, and accredited. Module 1: Foundation Course in Clinical Research and GCP. Our training sessions are unique because they are fun, customized, topical, and accredited. Clinical Research Courses Medical research involving human subjects is strictly controlled by the Medicines Control Council of South Africa and it is mandated that the study team be well versed with the International (ICH) and SA Good Clinical Practice guidelines. Module 6: Effective Project Management ACRO (African Clinical Research Organisation) was the first South African, full-service, black economic empowerment, contract research organisation. The minimum eligibility for admission in which is a 55% score in graduation in the Medical science courses (MBBS, BDS etc.) We area private company, established in 2007, offering services both in Southern Africa and in other African regions. Marijke has been intimately involved with GCP and clinical research education for over 10 years. This means that you need to have attended a training course facilitated by an accredited GCP trainer. “Experto crede” is a Latin term that means “have faith in experience.” We are passionate about clinical research. Tel: +27 83 285 3473, © Copyright CREDE 2014. Module 5: Advanced Monitoring Skills. He started his career in 1995 with Schering Plough South Africa in medical / pharmaceutical marketing and clinical research. Click on the closest city to find the research studies that are available in your area. CREDE (Clinical Research, Education, and Development) is an independent organization that provides GCP and other clinical research training, education and development. We believe that the success of a study lies in the quality of its team members. A: No, GCP trainers in South Africa need to be accredited by the Health Professions Council of South Africa (HPCSA). A range of online short courses are offered in partnership with the Wits DigitalCampus DigitalCampus offers the most career-oriented online learning in South Africa, combining the renowned strength of Wits University's content with the business acumen and online learning capability of LRMG Performance Agency, one of South Africa's leading performance and learning consulting firms. Today’s top 54 Clinical Research Associate jobs in South Africa. Statistical considerations in clinical trials course code: COMH7207. We specialise in delivering training in the field of clinical research but also provide HR management courses along with soft-skills development and critical skills. Closing date for applications is 30 August 2011 . Our courses are available in Distance, Contact Tuition and E-Learning format to ensure that the education needs of all learners seeking to expand their academic or professional horizons are met. The South African Health Products Regulatory Authority (SAHPRA) has issued a […], Comments Off on GCP Training in South Africa, Q: Is Good Clinical Practice (GCP) a requirement for researchers in South Africa? All GCP training providers in South Africa are required to meet industry determined curriculum and GCP trainer criteria. This course will provide you with an overview of clinical research, various concepts of research and introduce…, This is a 1 day course with 6 hours teaching time. Dates: 19 to 23 September Accreditation involves an in depth review of the course content as well as the skills, background and expertise of the trainer. CREDE (Clinical Research, Education, and Development) is an independent organization that provides GCP and other clinical research training, education and development. Module 3: Training for Study Site coordinators and Research Nurses. We offer services both in Southern Africa and in other African regions.              [email protected] Should you require any information, if you want to book your place on a course, or would like to discuss training options, please contact Marijke at: Email: [email protected] | All rights reserved |, Clinical Research Education and Development, on Recruitment and Retention in studies (online course), Safety First: Managing Participant Safety and Adverse Events (Online & Face-to-Face), Recruitment and Retention in studies (online course), The Nuts & Bolts of putting a research study into operation: a workshop for Study Coordinators and Investigators, Adaptable and custom- made courses on aspects of clinical research administration, operations, and principles, Custom made site or study specific courses. Good Clinical Practice Training. Dramatic changes have occurred throughout South Africa in recent years in spite of the misconceptions of clinical research in the past. The following Clinical Coding short courses are offered: Basic Training in ICD-10 Coding (available online) Basic Anatomy and Physiology (available online) Basic Training in Complete Current Procedural Terminology SA (available online) At the end of the course a written assessment is done which…, These courses include training in important aspects and best practices of clinical research that are…, Study Specific Standard Operating Procedure (SOP) training: training designed around study specific SOP’s…, Comments Off on Recruitment and Retention in studies (online course), The CREDE Recruitment and Retention Course is online! This means that you need to have attended a training course facilitated by an accredited GCP trainer. Good Clinical Practice. A: No, in South Africa the training has to be based on SA GCP. Our programmes are unique in that they are based in experience, packed with relevant and useful content, and presented in a fun and interactive way. 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