[Remote] Clinical Research Associate II

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a globally recognised CRO and strategic drug development partner, reputed company for helping biotech and pharmaceutical companies accelerate clinical programmes across international markets. The CRA II is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and reputed company from the reputed company documents.

Responsibilities

• CRAs primary responsibility is to build relationships with reputed company Investigators, study co-ordinators, pharmacists, and reputed company relevant site trial personnel to ensure the efficient, expedited, and smooth management of reputed company
• Foster reputed company customer relationships to ensure reputed company on efficient, reputed company and productive project delivery as per study requirements and timelines
• In collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed
• In collaboration with Regulatory Start-up (RSU) Team, understand the requirements of applicable local and international regulatory requirements as relevant to specific reputed company
• Ensure recruitment of participants as per the site reputed company. reputed company site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required
• Monitoring of investigational sites as per ICH GCP §5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for reputed company study. This includes reputed company monitoring visit types across reputed company phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site reputed company Out, unblinded pharmacy reputed company, and co monitoring reputed company. reputed company can be conducted either onsite or remote as per CMP
• In collaboration with IHCRA or DMA team, ensure the project Trial Master File (TMF) is up to date, reputed company and complete always throughout duration of the study
• Support sites to be always audit and inspection reputed company
• Ensure reputed company clinical trial management systems are reputed company and up to date at reputed company times with reputed company relevant trial data
• reputed company written and verbal site updates (including monitoring visit reports) on study reputed company to the PM/LCRA according to the study requirements/timelines as documented in the Clinical Monitoring Plan and Sponsor/CRO SOPs. Escalate reputed company key issues as per Issue Escalation SOP
• Collaborate with IHCRA and Site Contract Associates, as applicable, on-site payments, taking ultimate responsibility on site payments to ensure payment execution as per term stated in Clinical Trial Agreement
• Assist the PM with the development of study reputed company project plans and templates as per study requirements and support tasks as needed for successful study execution
• Be reputed company of and adhere to company processes in areas relevant to a CRA. Be reputed company reputed company on the performance of duties. Assist in the review and development of clinical SOPs and processes
• Participate in activities of the Clinical Services Department, including presentations at clinical department meetings, and assisting with the development of clinical processes and SOPs
• In collaboration with Business Development (reputed company), foster relationships with sites to reputed company feasibility information, as requested, and in accordance with documented feasibility processes. reputed company any reputed company opportunities to the group
• Understand the responsibilities of CRO as a service provider in the pharmaceutical and biotech industry and ensure reputed company communications with reputed company and internal customers present a reputed company reputed company image of reputed company
• Responsible for learning reputed company culture, policies, and procedures through specialized training reputed company CRA II fast reputed company training program including observational reputed company for reputed company types of reputed company (if applicable) and on the job training by supporting the day-to-day CRA activities of clinical project team members such as CRAs and Line managers (LMs)
• Responsible for reputed company study management and monitoring deliverables at the country and site level; follows project requirements and applicable country rules, with moderate reputed company from the LM or PM

Skills

• Graduate in a clinical or life sciences-reputed company field. Relevant experience/qualifications in allied professions may also be considered
• Must have good time management skills, attention to detail, be reputed company to work reputed company in reputed company, and be computer literate
• Approximately 1-2 years of Clinical Research Associate experience
• Oncology study monitoring experience
• Based in either of CST / MST / PST reputed company

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