Clinical Research Associate / Sr. Clinical Research Associate

Nextvel Consulting LLP; Bengaluru; On-site; INR 400,000 - 800,000; Full time

Job summary

Nextvel Consulting LLP is seeking a Clinical Research Associate to manage Clinical Study projects and prepare trial-related documents. The role requires 2-6 years of clinical research experience and proficiency in Microsoft Excel.

The ideal candidate will possess strong analytical and problem-solving skills, along with the ability to work collaboratively within teams.

Qualifications

• 2-6 years experience in Clinical Research.
• Trained on current Good Clinical Practices and regulatory requirements.
• Self-motivated with strong organizational skills.

Responsibilities

• Handle Clinical Study projects with complete accountability.
• Prepare Clinical Trial documents and agreements.
• Conduct feasibility studies and support senior colleagues.

Skills

Clinical Research

Problem-solving skills

Analytical skills

Microsoft Excel

Communication skills

Education

Bachelor's degree in Life Sciences or related field

Job description

The Clinical Research Associate will perform the following duties:

Project related duties include:

• Handle Clinical Study projects in a team with complete accountability
• Preparation of Clinical Trial documents (like Study Protocols, Informed Consent Documents, Case Report Forms, Investigator’s Brochure etc.) on available templates.
• Prepare Clinical Trial Agreements and negotiate budgets with sites
• Conduct Study feasibilities
• Support in Pre-study and Post study duties
• Support in preparing for Ethics Committee and Regulatory Submissions
• Support in in-house coordination of the studies and support senior members of the team
• Prepare Presentations for Investigator Meeting and Regulatory Agencies
• Support senior colleagues in Conduct Site Selection, Study Initiation, Routine Monitoring and Close-out Visits
• Support senior colleagues in coordinating Safety Reporting
• Support in building Clinical Trial Databases
• Support in Data verification, collection of complete data, support cleaning, analysis of data and compilation of report
• Support in Investigational Product Management and control
• Maintain essential documents in-house and the oversee the maintenance at the site
• Perform travel as Required for Site Monitoring and Other Activities
• Perform any other tasks assigned by management from time to time

Non-Project related duties:

• Prepare Clinical SOPs
• Prepare training materials
• Help in regulatory filing
• Interface with clients, sites and investigators when required
• Participate in business meetings make presentation when required
• Accomplish jobs assigned from time to time to meet satisfaction of the management
• Work in alignment with the company objectives and common goal of the company

Skills/Experience

• 2-6 years experience in Clinical Research
• Trained on current Good Clinical Practices guidance and local and global regulatory requirements for clinical research.
• Self -motivated, research oriented, highly organized, strong analytical and problem-solving skills. good mathematical and statistical skills
• Excellent computer skills, proficiency in Microsoft office tools and especially excel spread sheet is an absolute must
• Solid Verbal and written communication skills necessary to interact smoothly with healthcare professionals and scientific community
• Multi-tasking and excellent time management skills
• Good understanding of applicable regulations prevailing for clinical research