Quantys Clinical, a leading Contract Research Organization (CRO) based in Gandhidham, Gujarat, is currently hiring for two key positions: Research Associate (Custodian) – Bioanalytical Research and Medical Writer. Established in April 2016, Quantys Clinical is renowned for its world-class services in bioequivalence testing and clinical research, serving the pharmaceutical and nutraceutical industries. The company operates from a state-of-the-art facility spread over 40,000 sq. ft. in Kandla SEZ (KASEZ), equipped with advanced bio-analytical laboratories and a team of full-time doctors and paramedical staff
Research Associate (Custodian) – Bioanalytical Research
Qualification: B.Pharma/B.Sc. (Life Science)
Experience: 0-3 years relevant experience
Job Location: Gandhidham (Gujarat)
Job Description:
- Operation of Deep freezers, Refrigerators, Thermo hygrometers, Thermometers.
- Handling of centralized monitoring systems such as Eurotherm and Lisaline.
- Biological sample receipt/shipment from/to other facilities/in-house.
- Management of biological samples like study samples, validation samples, and matrix lots.
- Procurement and handling of biological matrix lots as per requirement.
- Disposal of biological samples as per in-house SOP.
- Handling & Maintenance of Analytical Columns, working and reference standards.
- Archive relevant data as per SOP in coordination with QC associate.
Medical Writer
Qualification: B. Pharm, M. Pharm, Pharm.D, BDS, MBBS
Experience: 2-5 years
Job Location: Gandhidham (Gujarat)
Roles and Responsibilities:
- Inception, trial designing, review, and finalization of clinical trial documents (Synopsis, Protocol, ICF, CRF, IB, etc.).
- Annual study status reports, periodic safety update reports, final trial reports, clinical technical documents, SAE narratives.
- Review and study of received safety literature, product complaints, and callbacks.
- Writing narratives for Individual Case Reports and SUSARs for US-FDA.
- Filling of MedWatch forms with MedDRA coding and submission to US-FDA.
- Management of clinical trials with coordination and timely document retrieval from clinical trial sites, PI, CRO, and SMO.
- Medical writing of clinical trial documents and submission to EC and RA.
- Communication and management of CRO, SMOs, and vendors.
- Initiation and maintenance of TMF.
- Management and enhancement of trial recruitment.
- Investigational product management including labeling, blinding, randomization, dispatch, callbacks, and final reconsolidation.
- Monitoring, medical monitoring, site initiation, site audit, site close-out visits.
- Communication with trial sites, ethics committees, etc.
- CTRI registration of clinical trials.
- Inception and implementation of Standard Operating Procedures (SOP) and Work Instructions (WI) for the process.
About Quantys Clinical
Quantys Clinical is a NABL Certified, DCGI approved, and ISO Certified organization. The company has applied for a DSIR Certificate, further emphasizing its commitment to quality and excellence in clinical research With a strong focus on bioequivalence testing and clinical trials, Quantys Clinical offers comprehensive services across the entire spectrum of drug development, from pre-clinical research to clinical trials The company’s mission is to provide cutting-edge infrastructure and ensure compliance with regulatory requirements, making it a trusted partner for major healthcare organizations and pharmaceutical companies
How to Apply: Interested candidates can send their updated CV to hr@quantysclinical.com.
