Clinical Research Associate Level 2

Thermo Fisher Scientific India Pvt Ltd; Mumbai; Hybrid; INR 600.000 - 1.200.000; Vollzeit

Zusammenfassung

Thermo Fisher Scientific India Pvt Ltd in Mumbai is seeking a Clinical Research Associate (Level II) to coordinate site monitoring and management for global trials. You will perform risk-based monitoring, ensure data accuracy, and maintain regulatory compliance.

This role requires a life sciences degree or nursing qualification with at least 2 years of on-site monitoring experience, and willingness to travel 60-80% as needed.

Qualifikationen

• Bachelor's degree or nursing qualification with relevant experience.
• On-site monitoring experience is required (min 2 years).
• Based in Mumbai metro area with willingness to travel.

Aufgaben

• Monitors investigator sites with risk-based monitoring and RCA to reduce risk.
• Ensures data accuracy via SDR/SDV/CRF review during on-site and remote monitoring.
• Assesses investigational product through inventory and records review.
• Documents observations in reports using professional writing standards.
• Escalates deficiencies and follows through to resolution.
• Maintains contact between visits to ensure protocol adherence and data capture.
• Conducts monitoring tasks per the monitoring plan and participates in investigator meetings.
• Supports investigator payments and collaborates with project team on issue resolution.

Kenntnisse

Clinical monitoring

ICH GCP knowledge

Regulatory knowledge

Communication skills

Microsoft Office

Teamwork

Attention to detail

Ausbildung

Bachelor's degree in life sciences

Registered Nursing certification

Jobbeschreibung

CRA (Level II) Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. DESCRIPTION As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process.

What You’ll Do:

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
• Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
• Assess investigational product through physical inventory and records review.
• Documents observations in reports and letters in a timely manner using approved business writing standards.
• Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
• May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
• Conducts monitoring tasks in accordance with the approved monitoring plan.
• Participates in the investigator payment process.
• Ensures a shared responsibility with other project team members on issues/findings resolution.
• Investigates and follows-up on findings as applicable.
• Participates in investigator meetings as necessary.
• Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
• Performs trial close out and retrieval of trial materials.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
• Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
• Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
• Responds to company, client and applicable regulatory requirements/audits/inspections.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
• Contributes to other project work and initiatives for process improvement, as required.

REQUIREMENTS

Education and Experience Requirements:

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (including at least 2 years on-site monitoring experience)

Based In Metro city location - Mumbai, Delhi, Hyderabad, Bengaluru, Pune

Knowledge, Skills and Abilities:

• Proven clinical monitoring skills
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• Ability to manage Risk Based Monitoring concepts and processes
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
• Good organizational and time management skills
• Effective interpersonal skills
• Attention to detail
• Ability to remain flexible and adaptable in a wide range of scenarios
• Ability to work in a team or independently as required
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills

Working Conditions and Environment:

Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment. Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays. Exposure to biological fluids with potential exposure to infectious organisms. Personal protective equipment required such as protective eyewear, garments and gloves. Exposure to fluctuating and/or extreme temperatures on rare occasions

Experience Level Mid Level