Are you passionate about clinical research and eager to contribute to advancing healthcare solutions? Orbit, a leading name in the clinical research and pharmacology field, is seeking a Clinical Research Associate to design and manage bioequivalence studies. With over 4.137 reviews, Orbit is renowned for its commitment to excellence and innovation in healthcare research. This exciting role is based in Ahmedabad (Gota) and offers a chance to work in a collaborative and dynamic environment.
Company Introduction
Orbit is a distinguished organization specializing in clinical research and bioequivalence studies. With a robust commitment to quality and compliance, Orbit has built a reputation for delivering top-tier research that aligns with global regulatory standards, including FDA, EMA, and Health Canada guidelines. Joining Orbit means being part of a team that values scientific rigor and strives to improve healthcare outcomes worldwide.
Responsibilities of the Clinical Research Associate
As a Clinical Research Associate at Orbit, your responsibilities will include:
- Designing bioequivalence studies based on regulatory and scientific requirements.
- Developing comprehensive study protocols and ensuring adherence to GCP, GLP, and regulatory guidelines.
- Managing trial supplies, drug accountability, and execution of bioequivalence studies.
- Conducting site visits for monitoring trial activities and ensuring compliance.
- Collaborating with cross-functional teams, including clinical operations, data management, and biostatistics.
- Addressing regulatory queries and participating in audits and inspections related to bioequivalence studies.
- Reviewing clinical trial data for accuracy and completeness, ensuring high-quality results.
- Conducting risk evaluations, implementing mitigation strategies, and monitoring their effectiveness.
- Analyzing literature and in-vitro data to confirm bioequivalence of drug products.
Qualifications Required
- Educational Background:
Master’s or PhD in Pharmacology, Pharmaceutical Sciences, or related fields. - Experience:
- Minimum 4 years of experience in study design and on-site monitoring of bioequivalence studies.
- Demonstrated expertise in GCP, clinical trial management, and regulatory requirements.
- Knowledge:
- Strong understanding of pharmacokinetics, biostatistics, and clinical trial methodologies.
- Familiarity with ICH/GCP guidelines and software tools for pharmacokinetic analysis.
Skills Needed
- Analytical and Problem-Solving Abilities:
To manage unexpected challenges during studies effectively. - Organizational and Time-Management Skills:
To handle multiple projects and maintain study timelines. - Communication Skills:
For effective collaboration with site staff, investigators, and sponsors. - Technical Expertise:
Proficiency in tools used for pharmacokinetic analysis and regulatory documentation. - Travel Readiness:
Flexibility to travel frequently for site visits as required.
