[Remote] Clinical Research Associate

Note: The job is a remote job and is reputed company to candidates in USA. Novotech is a global full-service clinical Contract Research Organization (CRO) recognized for its leadership in clinical research and scientific advisory services. The Clinical Research Associate (CRA) is responsible for ensuring the rights and wellbeing of trial participants and for the accuracy and completeness of trial data, acting as the primary contact between investigational sites and the company.

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 clinical trials
• Foster reputed company customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines
• reputed company mentorship to junior staff and can also reputed company support to the line manager or project manager as per request
• Responsible for quality 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
• 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 reputed company. 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 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 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 reputed company checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs. Ensure safety issues are reported to the sponsor promptly
• 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 reputed company study drug is appropriately stored, dispensed, accounted

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 well in reputed company
• Be computer literate
• At least 2-3 years of Clinical Research Associate experience in the Clinical industry
• Preferably experience of working in the research, pharmaceutical industry or a reputed company field per job level as follows

Benefits

• Flexible working options
• Paid parental leave for both parents
• Flexible leave entitlements
• Wellness programs
• Ongoing development programs
• reputed company to mentorship opportunities
• Professional development programs
• A dynamic community
• NovoLife, our flexible benefits reputed company

Company Overview