Clinical Research Associate (CRA I) job vacancies: PPD Mumbai

• Join PPD as a Clinical Research Associate (CRA I) in Mumbai
• Why Choose PPD: A United Team for Success
• Summarized Purpose:
• Essential Functions: Your Impact
• Education and Experience: Your Background Matters
• Knowledge, Skills, and Abilities: Your Qualities
• Working Environment: Your Comfort
• Join PPD: Elevate Your Career in Clinical Research

Join PPD as a Clinical Research Associate (CRA I) in Mumbai

Are you ready to make an impact in the world of clinical research? PPD is seeking dedicated individuals to join our team as Clinical Research Associates (CRA I) at our Mumbai location. As a CRA at PPD, you will play a vital role in coordinating and managing various aspects of the clinical monitoring and site management process. We value our employees’ growth, offer exceptional training, and prioritize their well-being.

Why Choose PPD: A United Team for Success

At PPD, we aim to hire the best, nurture development, and recognize the strength of unity. Our commitment to fostering growth, award-winning training, and employee well-being defines our culture. Join us to access continuous career advancement opportunities and contribute to improving lives.

Summarized Purpose:

As a Clinical Research Associate, your role involves performing and coordinating different facets of the clinical monitoring and site management process. You’ll conduct on-site and remote visits to assess protocol and regulatory compliance while ensuring accurate documentation. Collaboration with various sponsors and monitoring environments is crucial. As a specialist in site processes, you’ll ensure that trials are conducted following approved protocols, ICH-GCP guidelines, regulations, and SOPs, prioritizing subjects’ rights, well-being, and data reliability. Your responsibilities also include ensuring audit readiness and fostering collaborative relationships with investigational sites.

Essential Functions: Your Impact

• Apply a risk-based monitoring approach to investigator sites, utilizing root cause analysis, critical thinking, and problem-solving skills to identify process failures and implement corrective/preventive actions.
• Ensure data accuracy through activities like SDR, SDV, and CRF review via on-site and remote monitoring.
• Assess investigational products through physical inventory and records review.
• Document observations in reports and letters adhering to approved business writing standards.
• Escalate deficiencies and issues to clinical management promptly and oversee issue resolution.
• Maintain regular contact with investigative sites between monitoring visits to confirm protocol compliance and timely data recording.
• Conduct monitoring tasks as per the approved monitoring plan.
• Participate in investigator meetings and assist in identifying potential investigators.
• Initiate clinical trial sites to ensure protocol and regulatory compliance, making recommendations as needed.
• Facilitate communication among investigative sites, the client company, and internal project teams.
• Respond to company, client, and regulatory requirements/audits/inspections.
• Complete administrative tasks like expense reports and timesheets.

Education and Experience: Your Background Matters

• Bachelor’s degree in a life sciences-related field, Registered Nursing certification, or equivalent.
• Minimal clinical monitoring experience (comparable to 2 years) gained in clinical trials, medical research, clinical research, or health sciences field.
• Valid driver’s license where applicable.

Knowledge, Skills, and Abilities: Your Qualities

• Basic medical/therapeutic area knowledge and understanding of medical terminology.
• Proficiency in ICH GCPs, applicable regulations, and procedural documents.
• Effective communication skills, both written and verbal.
• Good interpersonal skills and customer focus.
• Strong organizational and time management skills.
• Flexibility and adaptability in various scenarios.
• Critical thinking, root cause analysis, and problem-solving skills.
• Ability to manage Risk-Based Monitoring concepts and processes.
• Capability to work independently and in a team.
• Proficiency in Microsoft Office and willingness to learn new software.
• Strong command of the English language.

Working Environment: Your Comfort

PPD prioritizes the well-being of its employees, ensuring a healthy and balanced environment where they can flourish. Here are the working environment/requirements for this role:

• Effective communication with diverse groups of people.
• Ability to work upright and stationary during working hours.
• Flexibility to work in non-traditional environments.
• Proficiency in standard office equipment and technology.
• Successful performance under pressure while managing multiple projects.
• Exposure to potentially hazardous elements found in healthcare or laboratory environments.
• Independent travel, up to 80%, including automobiles, airplanes, and trains.

Join PPD: Elevate Your Career in Clinical Research

If you’re passionate about clinical research and ready to contribute to impactful projects, PPD welcomes you to send your application to us. Join us and be a vital part of a team dedicated to making a difference.