" \u003cdiv class=\"ja-job-details\"\u003e \u003ch2 class=\"title\"\u003eSenior Clinical Research Associate I/II\u003c/h2\u003e \u003cdiv class=\"meta\"\u003e \u003cul class=\"classifications\"\u003e \u003cli data-id=\"23519\"\u003e Clinical Operations \u003c/li\u003e \u003cli data-id=\"23520\"\u003e Senior CRA \u003c/li\u003e \u003cli data-id=\"23521\"\u003e North America \u003c/li\u003e \u003cli data-id=\"23522\"\u003e Permanent / Full Time \u003c/li\u003e \u003c/ul\u003e \u003cp class=\"date-posted\"\u003e 30/10/2026 \u003c/p\u003e \u003c/div\u003e \u003cdiv class=\"description\"\u003e \u003cstrong\u003eWho are we?\u003c/strong\u003e\u003cbr\u003eWe\u0027re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980\u0027s. If you already work in this industry you\u0027ll know that we are experts in our field.\u003cbr\u003e\u0026nbsp;\u003cbr\u003e\u003cstrong\u003eWhy should you join Avance Clinical?\u003c/strong\u003e\u003cbr\u003eWe appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.\u003cbr\u003e\u0026nbsp;\u003cbr\u003eWe are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.\u003cbr\u003e\u0026nbsp;\u003cbr\u003e \u003cstrong\u003eBroad Purpose\u003c/strong\u003e\u0026nbsp;\u003cbr\u003e Avance Clinical\u0026nbsp;is\u0026nbsp;a Contract\u0026nbsp;Research\u0026nbsp;Organisation\u0026nbsp;which\u0026nbsp;offers\u0026nbsp;specialised services\u0026nbsp;supporting\u0026nbsp;drug development\u0026nbsp;for\u0026nbsp;the pharmaceutical and biotechnology\u0026nbsp;industry.\u0026nbsp;\u003cbr\u003e \u0026nbsp;\u003cbr\u003e The Senior Clinical Research Associate I (SCRA I)\u0026nbsp;perform\u0026nbsp;assigned trial related duties and functions ensuring the trial is conducted\u0026nbsp;in accordance with\u0026nbsp;the protocol; company Standard Operating Procedures (SOPs), ICH GCP\u0026nbsp;guidelines\u0026nbsp;and other applicable regulatory requirements. Responsibilities include service provision, departmental systems and procedures support and reporting and may include mentoring of junior team members.\u0026nbsp;\u003cbr\u003e \u0026nbsp;\u003cbr\u003e \u003cstrong\u003eCore\u0026nbsp;Responsibilities\u0026nbsp;\u003c/strong\u003e\u0026nbsp;\u003cbr\u003e \u003cul\u003e \u003cli\u003eConduct\u0026nbsp;site\u0026nbsp;and\u0026nbsp;investigator\u0026nbsp;feasibility\u0026nbsp;activities.\u0026nbsp;\u003c/li\u003e \u003cli\u003eCoordinate\u0026nbsp;Human\u0026nbsp;Research\u0026nbsp;Ethics\u0026nbsp;Committee\u0026nbsp;submission\u0026nbsp;requirements\u0026nbsp;to\u0026nbsp;completion.\u0026nbsp;\u003c/li\u003e \u003cli\u003eDevelop\u0026nbsp;study-related\u0026nbsp;documents\u0026nbsp;or\u0026nbsp;plans\u0026nbsp;under\u0026nbsp;the\u0026nbsp;supervision\u0026nbsp;of\u0026nbsp;the\u0026nbsp;study\u0026nbsp;Project\u0026nbsp;Manager.\u0026nbsp;\u003c/li\u003e \u003cli\u003eFor\u0026nbsp;a\u0026nbsp;multi-site\u0026nbsp;study,\u0026nbsp;oversee\u0026nbsp;and\u0026nbsp;lead\u0026nbsp;the\u0026nbsp;operations\u0026nbsp;of\u0026nbsp;the\u0026nbsp;clinical\u0026nbsp;team\u0026nbsp;as\u0026nbsp;the\u0026nbsp;Lead\u0026nbsp;CRA\u0026nbsp;including development of Clinical Monitoring Plan, study-specific annotated report, reviewing Visit Reports.\u0026nbsp;\u003c/li\u003e \u003cli\u003ePerform\u0026nbsp;all\u0026nbsp;activities\u0026nbsp;(preparation,\u0026nbsp;execution,\u0026nbsp;and\u0026nbsp;follow-up)\u0026nbsp;associated\u0026nbsp;with\u0026nbsp;onsite\u0026nbsp;or\u0026nbsp;remote\u0026nbsp;Pre-Study Visits (PSV), Study Initiation Visits (SIV), Dose Witness Visits (DWV), Interim Monitoring Visits (IMV)\u0026nbsp;and\u0026nbsp;Close-out Visits (COV).\u0026nbsp;\u003c/li\u003e \u003cli\u003eGenerate\u0026nbsp;and\u0026nbsp;maintain\u0026nbsp;high\u0026nbsp;quality\u0026nbsp;confirmation\u0026nbsp;letters,\u0026nbsp;site\u0026nbsp;visit\u0026nbsp;reports,\u0026nbsp;follow-up\u0026nbsp;letters\u0026nbsp;and\u0026nbsp;other documentation related\u0026nbsp;site\u0026nbsp;monitoring and management to ensure compliance with ICH GCP, study\u0026nbsp;protocol\u0026nbsp;and regulatory requirements.\u0026nbsp;\u003c/li\u003e \u003cli\u003eMonitor participant source data, review Investigator Site Files (ISF), perform Investigational Product accountability,\u0026nbsp;meet\u0026nbsp;with\u0026nbsp;site\u0026nbsp;personnel,\u0026nbsp;and\u0026nbsp;ensure\u0026nbsp;procedures\u0026nbsp;are\u0026nbsp;conducted\u0026nbsp;in\u0026nbsp;accordance\u0026nbsp;with\u0026nbsp;the protocol and ICH GCP.\u0026nbsp;\u003c/li\u003e \u003cli\u003ePerform\u0026nbsp;protocol\u0026nbsp;review\u0026nbsp;as\u0026nbsp;requested.\u0026nbsp;\u003c/li\u003e \u003cli\u003eRaise\u0026nbsp;data\u0026nbsp;queries\u0026nbsp;in\u0026nbsp;the\u0026nbsp;Case\u0026nbsp;Report\u0026nbsp;Form\u0026nbsp;(CRF)\u0026nbsp;where\u0026nbsp;discrepancies\u0026nbsp;are\u0026nbsp;identified\u0026nbsp;and\u0026nbsp;work\u0026nbsp;with\u0026nbsp;site staff to ensure\u0026nbsp;timely\u0026nbsp;and\u0026nbsp;accurate\u0026nbsp;resolution.\u0026nbsp;\u003c/li\u003e \u003cli\u003eCollect\u0026nbsp;TMF\u0026nbsp;documentation\u0026nbsp;from\u0026nbsp;site\u0026nbsp;and\u0026nbsp;ensure\u0026nbsp;accurate\u0026nbsp;and\u0026nbsp;timely\u0026nbsp;filing\u0026nbsp;as\u0026nbsp;per\u0026nbsp;SOP\u0026nbsp;requirements.\u0026nbsp;\u003c/li\u003e \u003cli\u003eMaintain\u0026nbsp;effective\u0026nbsp;site\u0026nbsp;communication\u0026nbsp;to\u0026nbsp;proactively\u0026nbsp;manage\u0026nbsp;on-going\u0026nbsp;study\u0026nbsp;expectations\u0026nbsp;and\u0026nbsp;issues.\u0026nbsp;\u003c/li\u003e \u003cli\u003eParticipate\u0026nbsp;in\u0026nbsp;study-specific\u0026nbsp;or\u0026nbsp;vendor\u0026nbsp;audits\u0026nbsp;conducted\u0026nbsp;by\u0026nbsp;sponsors\u0026nbsp;or\u0026nbsp;regulatory\u0026nbsp;agencies,\u0026nbsp;and respond to audit observations, as\u0026nbsp;required.\u0026nbsp;\u003c/li\u003e \u003cli\u003eEnsure\u0026nbsp;Serious\u0026nbsp;Adverse\u0026nbsp;Events\u0026nbsp;are\u0026nbsp;reported\u0026nbsp;(initial\u0026nbsp;and\u0026nbsp;follow-up)\u0026nbsp;as\u0026nbsp;per\u0026nbsp;protocol\u0026nbsp;requirements.\u0026nbsp;\u003c/li\u003e \u003cli\u003eProvide\u0026nbsp;guidance\u0026nbsp;and\u0026nbsp;mentoring\u0026nbsp;to\u0026nbsp;less\u0026nbsp;experienced\u0026nbsp;staff\u0026nbsp;during\u0026nbsp;co-monitoring\u0026nbsp;visits\u0026nbsp;and\u0026nbsp;facilitating\u0026nbsp;accompanied site visits.\u0026nbsp;\u003c/li\u003e \u003cli\u003eOther duties as directed by Line Management or delegate\u0026nbsp;in line with\u0026nbsp;skills,\u0026nbsp;experience\u0026nbsp;and/or\u0026nbsp;qualifications.\u0026nbsp;\u003c/li\u003e \u003c/ul\u003e \u003cstrong\u003eDepartmental Responsibilities\u0026nbsp;\u003c/strong\u003e\u0026nbsp;\u003cbr\u003e \u003cul\u003e \u003cli\u003eFoster the on-going commitment to\u0026nbsp;maintaining\u0026nbsp;a healthy team\u0026nbsp;culture\u0026nbsp;and\u0026nbsp;promoting\u0026nbsp;good\u0026nbsp;morale,\u0026nbsp;by actively\u0026nbsp;participating\u0026nbsp;in regular Clinical Operations Team meetings.\u0026nbsp;\u003c/li\u003e \u003cli\u003eMaintain\u0026nbsp;effective\u0026nbsp;communication\u0026nbsp;with\u0026nbsp;other\u0026nbsp;members\u0026nbsp;of\u0026nbsp;the\u0026nbsp;department.\u0026nbsp;\u0026nbsp;\u003c/li\u003e \u003cli\u003eProactively\u0026nbsp;identify\u0026nbsp;risks\u0026nbsp;related\u0026nbsp;to\u0026nbsp;departmental\u0026nbsp;service\u0026nbsp;provision\u0026nbsp;and\u0026nbsp;assist\u0026nbsp;in\u0026nbsp;their\u0026nbsp;mitigation\u0026nbsp;and\u0026nbsp;resolution.\u0026nbsp;\u003c/li\u003e \u003cli\u003eManage\u0026nbsp;and\u0026nbsp;track\u0026nbsp;business\u0026nbsp;related\u0026nbsp;expenses\u0026nbsp;as\u0026nbsp;per\u0026nbsp;company\u0026nbsp;policy.\u0026nbsp;\u003c/li\u003e \u003cli\u003eIdentify\u0026nbsp;training\u0026nbsp;needs\u0026nbsp;of\u0026nbsp;the\u0026nbsp;Clinical\u0026nbsp;Operations\u0026nbsp;Team\u0026nbsp;and\u0026nbsp;provide\u0026nbsp;recommendations\u0026nbsp;for\u0026nbsp;appropriate training\u0026nbsp;actions and programs.\u0026nbsp;\u003c/li\u003e \u003cli\u003eContribute\u0026nbsp;to\u0026nbsp;the\u0026nbsp;development\u0026nbsp;of\u0026nbsp;departmental\u0026nbsp;SOPs\u0026nbsp;as\u0026nbsp;required.\u0026nbsp;\u003c/li\u003e \u003cli\u003eParticipate\u0026nbsp;in\u0026nbsp;internal\u0026nbsp;Quality\u0026nbsp;Assurance\u0026nbsp;activities\u0026nbsp;as\u0026nbsp;required,\u0026nbsp;including\u0026nbsp;responding\u0026nbsp;to\u0026nbsp;internal\u0026nbsp;audit\u0026nbsp;findings.\u0026nbsp;\u003c/li\u003e \u003c/ul\u003e \u0026nbsp;\u003cbr\u003e \u003cstrong\u003eOrganisational Responsibilities\u003c/strong\u003e\u0026nbsp;\u003cbr\u003e \u003cul\u003e \u003cli\u003eEmbrace the core values of\u0026nbsp;Avance Clinical\u0026nbsp;and\u0026nbsp;endeavor\u0026nbsp;to\u0026nbsp;display those attributes at all times\u0026nbsp;with clients and staff alike.\u0026nbsp;\u003c/li\u003e \u003cli\u003eCommit to\u0026nbsp;Avance Clinical\u0026nbsp;training programs.\u0026nbsp;\u003c/li\u003e \u003cli\u003eAdhere to\u0026nbsp;Avance\u0026nbsp;quality systems.\u0026nbsp;\u003c/li\u003e \u003c/ul\u003e \u0026nbsp;\u003cbr\u003e All staff\u0026nbsp;are required to\u0026nbsp;take reasonable care for their own health and safety and that of other personnel who may be affected by their conduct.\u0026nbsp;\u0026nbsp;\u0026nbsp;\u003cbr\u003e The accountabilities as specified above may be altered\u0026nbsp;in accordance with\u0026nbsp;the changing requirements of the position.\u0026nbsp;\u003cbr\u003e \u0026nbsp;\u003cbr\u003e \u003cstrong\u003eQualifications,\u0026nbsp;Skills,\u0026nbsp;and Experience\u003c/strong\u003e\u0026nbsp;\u003cbr\u003e \u003cul\u003e \u003cli\u003eBachelor\u0027s\u0026nbsp;level\u0026nbsp;degree\u0026nbsp;in\u0026nbsp;life\u0026nbsp;sciences,\u0026nbsp;pharmacy,\u0026nbsp;nursing,\u0026nbsp;or\u0026nbsp;equivalent\u0026nbsp;field.\u0026nbsp;\u003c/li\u003e \u003cli\u003ePrevious\u0026nbsp;experience\u0026nbsp;as\u0026nbsp;a\u0026nbsp;CRA\u0026nbsp;in\u0026nbsp;a\u0026nbsp;CRO\u0026nbsp;or\u0026nbsp;Pharma\u0026nbsp;company\u0026nbsp;for\u0026nbsp;at\u0026nbsp;least\u0026nbsp;3-4\u0026nbsp;years.\u0026nbsp;\u003c/li\u003e \u003cli\u003eFormal\u0026nbsp;ICH\u0026nbsp;GCP\u0026nbsp;training\u0026nbsp;and\u0026nbsp;a\u0026nbsp;working\u0026nbsp;knowledge\u0026nbsp;of\u0026nbsp;ICH\u0026nbsp;GCP\u0026nbsp;Guidelines\u0026nbsp;and\u0026nbsp;other\u0026nbsp;applicable regulatory requirements.\u0026nbsp;\u003c/li\u003e \u003cli\u003eClear\u0026nbsp;understanding\u0026nbsp;of\u0026nbsp;the\u0026nbsp;requirement\u0026nbsp;to\u0026nbsp;adhere\u0026nbsp;strictly\u0026nbsp;to\u0026nbsp;client\u0026nbsp;confidentiality.\u0026nbsp;\u003c/li\u003e \u003cli\u003eEffective written and oral communications skills, including the ability to keep clients, senior management\u0026nbsp;and\u0026nbsp;other\u0026nbsp;stakeholders\u0026nbsp;informed\u0026nbsp;of\u0026nbsp;project\u0026nbsp;updates\u0026nbsp;and\u0026nbsp;other\u0026nbsp;pertinent\u0026nbsp;information.\u0026nbsp;\u003c/li\u003e \u003cli\u003eDemonstrated\u0026nbsp;ability\u0026nbsp;to\u0026nbsp;take\u0026nbsp;initiative\u0026nbsp;in\u0026nbsp;problem\u0026nbsp;solving\u0026nbsp;and\u0026nbsp;in\u0026nbsp;exercising.\u0026nbsp;good\u0026nbsp;judgment.\u0026nbsp;\u003c/li\u003e \u003cli\u003eAwareness\u0026nbsp;of\u0026nbsp;Privacy\u0026nbsp;Legislation\u0026nbsp;as\u0026nbsp;it\u0026nbsp;applies\u0026nbsp;to\u0026nbsp;the\u0026nbsp;Clinical\u0026nbsp;Trial\u0026nbsp;environment.\u0026nbsp;\u003c/li\u003e \u003cli\u003eAbility\u0026nbsp;to\u0026nbsp;work\u0026nbsp;under\u0026nbsp;pressure\u0026nbsp;in\u0026nbsp;a\u0026nbsp;multi-disciplinary\u0026nbsp;team\u0026nbsp;environment.\u0026nbsp;\u003c/li\u003e \u003cli\u003eWillingness\u0026nbsp;to\u0026nbsp;work\u0026nbsp;in,\u0026nbsp;and\u0026nbsp;be\u0026nbsp;supportive\u0026nbsp;of,\u0026nbsp;a\u0026nbsp;positive\u0026nbsp;and\u0026nbsp;dynamic\u0026nbsp;team\u0026nbsp;culture.\u0026nbsp;\u003c/li\u003e \u003cli\u003eAbility\u0026nbsp;to\u0026nbsp;travel.\u0026nbsp;Moderate\u0026nbsp;level\u0026nbsp;of\u0026nbsp;interstate\u0026nbsp;travel\u0026nbsp;may\u0026nbsp;be\u0026nbsp;required\u0026nbsp;(up\u0026nbsp;to\u0026nbsp;50%).\u0026nbsp;\u003c/li\u003e \u003c/ul\u003e \u003cstrong\u003eWhat we offer\u003c/strong\u003e\u003cbr\u003e \u003cul\u003e \u003cli\u003eStimulating work\u003c/li\u003e \u003cli\u003eProject diversity\u003c/li\u003e \u003cli\u003eAn intellectual challenge\u003c/li\u003e \u003cli\u003eAn agile \u0026amp; flexible workplace\u003c/li\u003e \u003cli\u003eOpportunity to progress\u003c/li\u003e \u003cli\u003eStability\u003c/li\u003e \u003cli\u003eSense of community\u003c/li\u003e \u003cli\u003eA leadership team that are working together on a common goal\u003c/li\u003e \u003cli\u003eFlexible work options\u003c/li\u003e \u003cli\u003eGreat tools / tech to do your job\u003c/li\u003e \u003c/ul\u003e \u003c/div\u003e \u003cdiv class=\"apply\"\u003e \u003ca class=\"back-link\" href=\"#\" title=\"Back to search results\"\u003eBack to search results\u003c/a\u003e \u003cinput type=\"button\" class=\"ja-button\" data-job-id=\"921431\" value=\"Apply Now\" title=\"Apply Now\" /\u003e \u003c/div\u003e \u003c/div\u003e "