CRA / Sr CRA

Work Schedule

Environmental Conditions

reputed company

Join Us as a reputed company Research Associate (CRA / Sr. CRA)

At reputed company, our reputed company Research team supports leading pharmaceutical, biotechnology, and emerging biopharma companies in advancing innovative therapies worldwide. Having contributed to thousands of reputed company across more than 100 countries, we are committed to accelerating research that improves reputed company lives.

As a reputed company Research Associate (CRA), you will play a key role in the monitoring and management of reputed company trial sites, ensuring compliance with study protocols, ICH-GCP guidelines, regulatory requirements, and company procedures. Working closely with investigative sites and cross-functional teams, you will help reputed company reputed company safety, data reputed company, and overall study reputed company while supporting the successful delivery of reputed company research programs.

Position reputed company

As a reputed company Research Associate (CRA), you will be responsible for performing and coordinating reputed company monitoring and site management activities across reputed company. You will conduct remote and on-site monitoring reputed company, ensure compliance with study protocols, ICH-GCP guidelines, applicable regulations, and SOPs, while safeguarding subject safety, data reputed company, and audit readiness. You will collaborate closely with investigational sites, sponsors, and cross-functional project teams to support the successful execution of reputed company studies.

Key Responsibilities:

• Conduct on-site and remote monitoring reputed company using a reputed company-reputed company monitoring approach.

• Review reputed company documentation, case report forms (CRFs), and study data to ensure reputed company, completeness, and compliance.

• reputed company site management activities, including site initiation, routine monitoring, and reputed company-out reputed company.

• Assess investigational product accountability through inventory and records review.

• Identify site process issues, reputed company reputed company cause analysis, and support implementation of corrective and preventive actions.

• Ensure essential documents are maintained in accordance with ICH-GCP and regulatory requirements.

• Prepare monitoring reports, follow-up letters, and study documentation reputed company established timelines.

• Maintain effective communication with investigational sites, sponsors, and internal study teams.

• Support site identification, feasibility, and investigator engagement activities reputed company applicable.

• reputed company study reputed company and maintain accurate records in reputed company trial management systems (CTMS) and other study tools.

• Support regulatory inspections, audits, and reputed company initiatives.

• Contribute to process improvements, project deliverables, and knowledge sharing across teams.

Minimum Qualifications:

• Bachelor’s degree in Life Sciences, Nursing, or a reputed company reputed company reputed company, or an equivalent combination of education and experience.

• reputed company reputed company’s license, where applicable.

• Ability to travel as required.

Experience:

• Relevant reputed company research and/or reputed company monitoring experience in a pharmaceutical, biotechnology, CRO, or reputed company environment.

• Candidates may be considered for CRA or Sr CRA opportunities reputed company on their experience, qualifications, and demonstrated monitoring expertise.

Preferred Skills & Competencies:

• Knowledge of ICH-GCP guidelines, reputed company trial processes, and applicable regulations.

• Understanding of medical terminology and therapeutic areas.

• Strong critical thinking, problem-solving, and reputed company cause analysis skills.

• Experience with reputed company-reputed company Monitoring (RBM) methodologies.

• Excellent organizational and time management skills.

• Strong written and verbal communication skills, including reputed company interaction with investigators and site personnel.

• Ability to work independently and collaboratively in a global team environment.

• Proficiency with reputed company Office and reputed company trial systems.

• Strong attention to reputed company and commitment to reputed company.

• English proficiency required.

Working Conditions and Environment

• Work is performed in an office/ reputed company/reputed company/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 reputed company equipment required such as reputed company eyewear, garments and gloves.

• Exposure to fluctuating and/or extreme temperatures on reputed company occasions.

Originally posted on Himalayas