- Job Role: Clinical Research Associate
- Salary: Not Disclosed
- Location: Kolkata, Mumbai
- Company: ICON
- Qualifications: Any Graduate
- Experience: 1 – 3 years
ABOUT ICON
ICON percent is a worldwide leader in clinical research and healthcare intelligence, offering outsourced improvement and commercialization offerings to pharmaceutical, biotechnology, and scientific device industries. Founded in 1990 and headquartered in Dublin, Ireland, ICON operates in over 40 countries, employing more than 39,000 specialists.
The business enterprise specializes in scientific trial management, statistics analytics, regulatory consulting, and decentralized scientific trials (DCTs). ICON leverages superior technology and progressive methodologies to supply great, value-effective answers that accelerate drug development. Its offerings span all stages of clinical trials, from protocol layout to up-market surveillance.
Recognized for its commitment to excellence and patient-centric approach, ICON collaborates with customers to force transformative clinical advancements. With a strong emphasis on sustainability and ethics, ICON keeps shaping the destiny of worldwide healthcare via impactful studies and innovation.
Job Description:
A Clinical Research Associate (CRA) ensures the integrity of scientific trials by using tracking study sites to confirm compliance with protocols, regulatory requirements, and moral standards. They oversee the recruitment of participants, information collection, and reporting accuracy, ensuring trials meet time limits and objectives. CRAs collaborate with investigators and sponsors, control documentation, and address problems to hold examinations first-class. Strong communication, analytical, and organizational talents are vital, alongside information of Good Clinical Practice (GCP). Typically, CRAs work across a couple of websites contributing to improvements in scientific research and affected person care.
Requirements and Skills for Clinical Research Associate (CRA):
Educational Requirements:
- Bachelor’s degree in existing sciences, clinical sciences, pharmacy, or a related discipline.
- Advanced stages (e.g., Master’s or Ph.D.) in a relevant area are a plus.
- Certifications in scientific research (e.g., ACRP, SOCRA) are fantastic.
Experience:
- Entry-degree CRAs may require 1-2 years of associated revel in clinical trials or studies.
- Senior CRAs usually need 3-5 years of monitoring enjoy in clinical trials.
- Familiarity with diverse levels of clinical trials (Phase I-IV).
Technical Skills:
- Thorough expertise in Good Clinical Practice (GCP) recommendations and regulatory requirements (e.g., FDA, EMA).
- Proficiency in medical trial monitoring gear and software programs, including CTMS and EDC systems.
- Familiarity with medical terminology and trial documentation, which include protocols, case file forms (CRFs), and informed consent paperwork.
Key Skills:
Analytical Skills:
- Ability to interpret trial records and become aware of inconsistencies or deviations.
- Attention to element to ensure compliance with protocols and rules.
Organizational Skills:
- Capability to manage a couple of sites and research concurrently.
- Efficient in making plans for website visits, preparing reports, and maintaining timelines.
Communication Skills:
- Clear and professional verbal and written communique with investigators, sponsors, and team members.
- Ability to educate and manual web page group of workers on protocol adherence.
Problem-Solving Skills:
- Proactive in figuring out and resolving problems at some stage in trials.
- Strong selection-making capacity below time-touchy conditions.
Technical Adaptability:
- Skilled in using digital tools and adapting to evolving medical technologies.
- Knowledge of records analysis and reporting software programs is a plus.
Additional Requirements:
- Willingness to tour frequently for on-web page tracking.
- Strong ethical judgment and dedication to affected person safety.
- Ability to toy independently and collaboratively in pass-purposeful teams.
- Fluency in English; extra language abilities are useful for worldwide trials.
A successful CRA combines technical know-how with interpersonal competencies to ensure scientific trials are conducted efficaciously, ethically, and in compliance with all rules.
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