Job Description

About Us

Cliantha Research is a full-service Clinical Research Organization (CRO) that provides comprehensive and integrated offerings in Early Phase, Late Phase, Respiratory, Tobacco Research, Dermatology, Consumer Research, Research Lab, IVRT, Biometrics, Pharmacovigilance & Medical Services, and Environmental Exposure Chambers (EECs).

With several advanced clinical sites and bio-analytical laboratories in North America and India, Cliantha now has presence in 4 countries along with a strong team of 1000+ professionals. Some of the key regulators, such as the USFDA, EMA, AGES, ANSM, AMPS, MCC South Africa, Health Canada, DCGI, CAP, NABL, Turkey MOH, Thailand MoPH and others have successfully inspected Cliantha across the globe.

Cliantha Research is headquartered in Ahmedabad and has expanded its domestic presence with 5 regional offices & international presence with offices in USA (Florida & New Jersey) & Canada (Mississauga & Scarborough).

JOB SUMMARY:

Function as Chemist for the conduct of assay from sample analysis, method development and validation for IVRT/IVPT studies. Sample analysis from plasma, blood, urine and tissue.

BASIC SKILLS AND ABILITIES:

Demonstrate ability to perform sample assay, development and validation of methods for IVRT, IVPT and bioanalytical assay using HPLC and LC/MS/MS systems in accordance with regulatory guidelines. Knowledge of basic regulatory guidelines for the conduct of BA/BE studies for the analytical and statistical phases.

MINIMUM EDUCATION TRAINING AND EXPERIENCE REQUIRED:

A minimum of B.Sc/ B.Pharm or equivalent education having at least six years of relevant experience unless demonstrated competence through work experience.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Note: These statements reflect the general description of the position and are not intended to be an all-inclusive list of tasks to which the employee may be assigned.

STUDY RELATED ACTIVITIES:

1. Engage in method development of IVPT/IVRT, Bioanalytical assays for multiple matrices including serum, plasma and urine.

2. Design and execute own daily tasks with an understanding of the timelines and how the activities fit into a larger project.

3. Works on projects of routine to complex scope in which analysis of assay components, procedures or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action.

4. Investigate, create and develop new methods and technologies for project advancement.

5. Perform relevant testing/assays and maintain detailed documentation, including laboratory notebook, for clinical and non-clinical GLP studies.

6. Prepare and characterize critical assay reagents.

7. Serve as a technical expert on lab instrumentation, software and/or assay procedures, documentation and/or GLP study protocols.

8. Adhere to GLP/GCP guidelines.

9. Maintains high level of technical expertise through familiarity with scientific literature.

10. Review the IVRT/IVPT and bioanalytical data.

11. Review analytical procedure sheets and method validation reports as applicable.

12. Perform the extraction of samples using wet chemistry.

13. Centrifuges, evaporators, freeze specimens as required.

14. Performs aliquots of samples for wet chemistry.

15. Performs wet chemistry according to study protocol guidelines and/or SOPs.

16. Completes AP sheets and makes log book entries as required by protocol and/or SOP.

17. Complete all other assigned duties by the supervisor within Lab following relevant SOPs and protocol.

GENERAL LAB DUTIES:

Prepares required reagents and solvents.

ADMINISTRATIVE DUTIES:

Conforms to training schedule for own position and maintains awareness of SOP content, according to company requirements.

Job Type: Full-time

Pay: $45,000.00-$55,000.00 per year

Ability to commute/relocate:

Scarborough, ON M1H 2Z8: reliably commute or plan to relocate before starting work (required)
Work Location: In person