Job Opportunity - Drug Substance (Viral Vaccine Experience) Bharat Biotech is looking for skilled professionals with hands-on experience in Drug Substance manufacturing for Viral Vaccines. Details are provided below 1. Location: Hyderabad 2. Experience: 2-6 Years 3. Key Skills & Experience Required a. Experience in Upstream /Downstream Processing of viral vaccines b. Operation and handling of bioreactors, fermenters, centrifuges, chromatography systems, filtration units c. Knowledge of cell culture techniques (mammalian/avian cell lines) d. Familiarity with aseptic techniques, GMP documentation, batch records e. Understanding of process optimization, scale-up, and technology transfer f. Exposure to in-process testing, troubleshooting, and equipment cleaning/sterilization g. Ability to work in a regulated, fast-paced manufacturing environment 4. How to Apply Interested candidates can share their updated CV to kiran4978@bharatbiotech.com Mention subject line as: Appl...
Pellucid Life science requires Clinical Research Associate (CRA) / Clinical Research Coordinator (CRC)
Details are provided below
Job Title: Clinical Research Associate (CRA) / Clinical Research Coordinator (CRC)
Key Skills:
- Clinical Research
- Project Management
- Clinical Research Coordination
Role:
- Senior Clinical Research Associate / Coordinator
Work Experience (Years):
- 3-7 Years
Location: Ahmedabad Ashram Road (Gujarat)
Company Industry:
- Pharmaceutical & Life Sciences, Biotechnology
Educational Qualification:
- Any graduate with a Clinical Research degree or diploma after graduation
Job Description:
We are seeking an experienced Clinical Research Associate (CRA) / Clinical Research Coordinator (CRC) to manage and oversee the execution of clinical trials in collaboration with CROs, clinical sites, and cross-functional teams. The successful candidate will be responsible for ensuring the clinical trial is conducted in accordance with study protocols, GCP standards, and regulatory guidelines.
Key Responsibilities:
- Oversee the management of clinical trials, including coordination with CROs and study sites (as required).
- Ensure compliance with study protocols, GCP, and relevant regulatory requirements at all stages of the trial.
- Perform source data verification, ensuring the accuracy, completeness, and integrity of study data.
- Monitor subject enrollment, track adherence to inclusion/exclusion criteria, and ensure timely progress of the study.
- Collect, review, and maintain essential study documentation, including regulatory submissions and informed consent forms.
- Serve as a primary point of contact for investigators, site staff, and CROs to resolve queries and provide guidance.
- Identify, document, and report adverse events and protocol deviations; ensure appropriate follow-up actions.
- Conduct site audits and inspections to ensure protocol adherence and data integrity.
- Collaborate with cross-functional teams to ensure the smooth execution of clinical trials.
- Maintain accurate tracking, monitoring, and reporting documentation throughout the study lifecycle.
- Participate in study team meetings, contribute to study planning, protocol development, and other study-related activities.
Qualifications & Requirements:
- 3-7 years of experience in clinical research, preferably in a pharmaceutical, biotech, or nutraceutical setting.
- Proven experience in clinical trial management, site monitoring, and coordination with CROs.
- Strong knowledge of GCP, ICH guidelines, and regulatory standards.
- Excellent communication, organizational, and project management skills.
Apply: hr@pellucidlifesciences.com
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