Clinical Research Associate-II

The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites, Novotech, and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.

Responsibilities

• Responsible for learning the company culture, policies, and procedures through specialized training called CRA II fast track training program including observational visits for all types of visits (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 quality study management and monitoring deliverables at the country and site level; follows project requirements and applicable country rules, with moderate oversight from the LM or PM.
• CRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials.
• Foster internal and external customer relationships to ensure focus on efficient, timely 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 clinical trials.
• Ensure recruitment of participants as per the site target. Drive 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 each study. This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits. Visits can be conducted either onsite or remote as per CMP.
• Ensure the rights & wellbeing of trial participants are protected, including consent form checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs.
• Ensure safety issues are reported to the sponsor promptly. ü Verify trial data are accurate and complete, ensure CRF data and queries are completed and resolved as per the study timelines documented in the Clinical Monitoring Plan.
• Ensure all study drug is appropriately stored, dispensed, accounted for, and reconciled as per the Clinical Monitoring Plan and the Protocol.
• In collaboration with IHCRA or DMA team, ensure the project Trial Master File (TMF) is up to date, current and complete always throughout duration of the study, Support sites to be always audit and inspection ready.
• Ensure all clinical trial management systems are current and up to date at all times with all relevant trial data.
• Provide written and verbal site updates (including monitoring visit reports) on study progress to the PM/LCRA according to the study requirements/timelines as documented in the Clinical Monitoring Plan and Sponsor/Novotech SOPs.
• Escalate all 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 related project plans and templates as per study requirements and support tasks as needed for successful study execution.
• Demonstrate a thorough understanding of ICH GCP, The Declaration of Helsinki, and any local guidelines as they apply to the investigator, sponsor, monitor, and IEC.
• Be aware of and adhere to company processes in areas relevant to a CRA. Be quality focused 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 (BD), foster relationships with sites to provide feasibility information, as requested, and in accordance with documented feasibility processes, Highlight any BD opportunities to the group.
• Understand the responsibilities of Novotech as a service provider in the pharmaceutical and biotech industry and ensure all communications with external and internal customers present a positive professional image of the company.

Qualifications

• Graduate in a clinical or life sciences-related field.
• Relevant experience/qualifications in allied professions may also be considered.
• Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate.
• Experience of working in the research, pharmaceutical industry or a related field
• Approximately 1-2 years of Clinical Research Associate experience or equivalent experience (CRA II fast track) in other roles in the Clinical industry