Clinical Research Associate / CRA

Location:	– Johannesburg, Cape Town, Durban, Pretoria, and Bloemfontein, South Africa
Job Type:	Permanent
Posted:	19th Oct 2010
Closing Date:	1st Jan 2010
Posted By:	ClinTec International Ltd.
Details:
Clinical Research Associate / CRA ClinTec International is a UK-based, dynamic privately owned full service Contract Research Organisation with presence in over 40 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assist in their key product development efforts for over a decade. At ClinTec International we pride ourselves provides high quality, flexible and professional services and solutions to our clients. ClinTec International has a wealth of experience in managing clinical trials in all major therapeutic categories including oncology, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology. Job Summary: Due to a period of sustained expansion and increased demand from clients, a number of outstanding career opportunities have arisen within ClinTec International, a truly unique CRO, for talented Senior Clinical Research Associate(s) at all levels to join our experienced team throughout South Africa. ClinTec have strong partnerships with some of the world’s leading pharmaceutical companies and our SCRA’s can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. ClinTec International offers a competitive salary and rewards package. The SCRA’s in South Africa will be home-based, and cover sites within their local region with minimal proportionate travel. There will be a need to travel on occasion to Johannesburg, or internationally for investigator meetings / HQ events from time to time. Summary: The Senior Clinical Research Associate(s) will identify, select, initiate and close-out appropriate investigational sites for clinical studies. The successful candidate(s) will monitor these sites in order to ensure ensuring compliance to the study protocol, Standard Operating Procedures, applicable regulations, and the principles of ICH-GCP. The CRA will also be charged with ensuring the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget. Role Description • Site management to ensure proper adherence to protocol, source data verification and assess CRF entries • Develop and manage relationships at selected investigative sites forging strong working partnerships with investigative team on behalf of the client. • Monitor clinical trials to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures • Perform pre-study initiation, interim monitoring and close out visits as required • Carry out drug formulation administration procedures and documentation records • Ensure adequacy of drug shipment and drug accountability • Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required • Organise / attend investigator meetings as required • Provide support to the Project Manager / Country Manager with ad-hoc tasks as required Required Experience, Skills and Abilities Essential Criteria • Bachelors degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline • Expert level understanding of the drug development process • Experience across a wide range of clinical indications / therapeutic areas • Significant experience in performing a Clinical Research Associate role at Senior CRA level • Work experience within either a hospital, medical / research centre environment, Contract Research Organisation or Pharmaceutical company • Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials • Ability to independently perform pre-study initiation, interim monitoring and close out visits as required • Good communication skills including the ability to present complex information to both clinical and non-clinical disciplines • Excellent presentation skills including the ability to meet exacting standards and a keen attention to detail • Fluency in English language (both written and spoken) • Willingness and ability to travel up to travel as required to sites locally Desirable Criteria: • Membership of local professional bodies or international clinical groups • Ability to mentor, train, supervise and inspire confidence in newcomers to the industry • Fluency in Afrikaans Application Details If you are relevant to this vacancy, please click apply below.

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