{"id":14604,"date":"2013-09-20T00:59:30","date_gmt":"2013-09-19T22:59:30","guid":{"rendered":"https:\/\/joblistsouthafrica.com\/?p=14604"},"modified":"2013-09-19T12:05:22","modified_gmt":"2013-09-19T10:05:22","slug":"quintiles-south-africa-clinical-research-associates","status":"publish","type":"post","link":"https:\/\/joblistsouthafrica.com\/quintiles-south-africa-clinical-research-associates.html","title":{"rendered":"Quintiles South Africa: Clinical Research Associates"},"content":{"rendered":"<div title=\"\">\n<h3>Junior or Senior Clinical Research Associates (Centurion\/ Johannesburg or Cape Town) Pipeline for future CRA vacancies.-1312095<\/h3>\n<p>We are looking to recruit\u00a0<b>CRA\u2019s<\/b>\u00a0and\u00a0<b>Senior CRA\u2019s\u00a0<\/b>to work in a busy clinical research department providing essential monitoring support. The role provides the opportunity to develop monitoring skills with advanced responsibilities, critical and central to the conduct of the clinical project.\u00a0\u00a0 The CRA oversees the progress of a Clinical Trial, ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable Regulatory requirements.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><b>Positions can be based in Cape Town or Pretoria\/Johannesburg and can potentially be home- or office based.<\/b><\/p>\n<p><b><span style=\"text-decoration: underline;\">PURPOSE<\/span><\/b><\/p>\n<p>Conduct monitoring visits for assigned protocols and study sites. Ensure that clinical research studies are conducted in<b><span style=\"text-decoration: underline;\">\u00a0<\/span><\/b>accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.<b><\/b><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><b><span style=\"text-decoration: underline;\">RESPONSIBILITIES<\/span><\/b><\/p>\n<ul>\n<li><span style=\"font-family: symbol;\">\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/span>Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.<\/li>\n<li><span style=\"font-family: symbol;\">\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/span>Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.<\/li>\n<li><span style=\"font-family: symbol;\">\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/span>Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.<\/li>\n<li><span style=\"font-family: symbol;\">\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/span>Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and\/or line manager.<\/li>\n<li><span style=\"font-family: symbol;\">\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/span>Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution.<\/li>\n<li><span style=\"font-family: symbol;\">\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/span>Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.<\/li>\n<li><span style=\"font-family: symbol;\">\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/span>May provide assistance to more less experienced clinical staff.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><b><span style=\"text-decoration: underline;\">How much travelling is involved?<\/span><\/b><\/p>\n<p>Approximately 60% although we try to limit it. It also depends on the study \u2013 some have more travelling involved than others.<\/p>\n<p>&nbsp;<\/p>\n<p><b><span style=\"text-decoration: underline;\">Therapeutic areas involved:<\/span><\/b><\/p>\n<p>TB, Diabetes, Rheumatoid Arthritis, Oncology, Cardiovascular, Flu, Osteo, HIV etc.<\/p>\n<p>&nbsp;<\/p>\n<p><b><span style=\"text-decoration: underline;\">Which business units?<\/span><\/b><\/p>\n<p>Clin Ops and GFR (sponsor dedicated unit)<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Qualifications<\/strong><\/p>\n<\/div>\n<div title=\"\"><b><span style=\"text-decoration: underline;\">REQUIRED KNOWLEDGE, SKILLS AND ABILITIES<\/span><\/b><br \/>\n\u2022 Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice<\/p>\n<p>(GCP) and International Conference on Harmonisation (ICH) guidelines<\/p>\n<p>\u2022 In depth therapeutic and protocol knowledge as provided in company training<\/p>\n<p>\u2022 Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a lap top computer<\/p>\n<p>\u2022 Strong written and verbal communication skills including good command of English language<\/p>\n<p>\u2022 Excellent organizational and problem-solving skills<\/p>\n<p>\u2022 Effective time management skills<\/p>\n<p>\u2022 Ability to manage competing priorities<\/p>\n<p>\u2022 Ability to establish and maintain effective working relationships with co-workers, managers and clients<\/p>\n<p>&nbsp;<\/p>\n<p><strong><span style=\"text-decoration: underline;\">MINIMUM REQUIRED EDUCATION AND EXPERIENCE<\/span><\/strong><\/p>\n<p>\u2022 Bachelor&#8217;s degree in a health care or other scientific discipline or educational equivalent and more than 1 year of on-site\u00a0monitoring experience; or equivalent combination of education, training and experience<\/p>\n<p>&nbsp;<\/p>\n<p><b><span style=\"text-decoration: underline;\">PHYSICAL REQUIREMENTS<\/span><\/b><\/p>\n<p>\u2022 Extensive use of telephone and face-to-face communication requiring accurate perception of speech<\/p>\n<p>\u2022 Extensive use of keyboard requiring repetitive motion of fingers<\/p>\n<p>\u2022 Regular sitting for extended periods of time<\/p>\n<p>\u2022 Frequent travel to sites, primarily domestic, may include international travel<\/p>\n<p>&nbsp;<\/p>\n<p><strong>How to Apply<\/strong><\/p>\n<p><a href=\"https:\/\/quintiles.taleo.net\/careersection\/10000\/jobdetail.ftl?job=910122\">Click on this link to apply online<\/a><\/p>\n<p>&nbsp;<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Junior or Senior Clinical Research Associates (Centurion\/ Johannesburg or Cape Town) Pipeline for future CRA vacancies.-1312095 We are looking to recruit\u00a0CRA\u2019s\u00a0and\u00a0Senior CRA\u2019s\u00a0to work in a busy clinical research department providing&#8230;..<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_newsletter_tier_id":0,"footnotes":"","jetpack_publicize_message":"","jetpack_is_tweetstorm":false,"jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","enabled":false}}},"categories":[374],"tags":[1918],"jetpack_publicize_connections":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.5 - 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