Clinical Research Associate I & II (India)

5 - 9 years

0 Lacs

Posted:1 day ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

At Allucent, you will be a Sr. Clinical Research Associate Contractor (Sr.CRA) responsible for independently controlling and monitoring investigational sites, ensuring clinical studies are conducted according to trial protocols and in compliance with SOPs, regulations, and Good Clinical Practice principles. **Key Responsibilities:** - Govern highest quality standards for trial monitoring activities. - Conduct all study tasks in compliance with quality standards while maintaining efficiency. - Monitor activities at clinical study sites to ensure adherence to protocols, ICH, GCP, SOPs, and regulations. - Prepare and submit quality Site Visits Reports and Contact reports. - Maintain and update CTMS in compliance with SOPs. - Act as Document Owner for collected documents. - Provide functional assistance to project team members. - Liaise with project team members and Sponsor to track study progress. - Track and supervise collection of ongoing study data. - Represent Allucent in the global medical research community. - Identify potential problems and propose solutions. - Supervise generation of electronic tracking systems. - Support project oversight and management. - Support site staff in preparation for audits and inspections. - Report Quality Issues and support resolution of Corrective and Preventative Actions. **Qualifications Required:** - At least five years of clinical monitoring experience. - Relevant life science degree or medical/nursing background. - Strong understanding and application of Good Clinical Practices and SOPs. - Excellent written and verbal communication skills in English and local language. - Ability to work in a fast-paced environment. - Proficiency in Word, Excel, and PowerPoint. - Flexibility to travel an average of 8 days on site per month. - Understanding of medical terminology and clinical trials. - Strong organizational and time management skills. - Ability to establish effective working relationships and prioritize tasks. - Ability to work independently and in a team. At Allucent, you will receive a comprehensive benefits package, competitive salaries, departmental study/training budget, flexible working hours, remote/hybrid working options, leadership and mentoring opportunities, internal growth opportunities, financial rewards for employee referrals, access to online training programs, eligibility for recognition programs, and more.,

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