Job Description

Cliantha is currently seeking a

Part-time Dermatologist Consultant

; who can fulfill its business needs and is looking for better learning and growth opportunities.

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 3 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).

The primary responsibility of the consultant is to ensure the study protocol and protocol amendment(s) in compliance with applicable regulatory requirements and good clinical practices (GCP).

GENERAL RESPONSIBILTIES

- Assumes responsibility for the conduct of the clinical investigation

Assumes responsibility for all trial-related decisions Signs the protocol and appropriate forms as required Signs the sponsor contract as appropriate Documents the various aspects of the trial Discloses conflicts of interest as described in the regulations (as applicable)
- Ensures protocol compliance

Demonstrates a thorough understanding of scientific and regulatory requirements of each protocol Assesses the suitability of subjects for clinical trials as specified in the inclusion/exclusion criteria of the protocol Assesses overall protocol feasibility Reviews the inclusion/exclusion criteria, schedule of visits, end point criteria and investigational article use with the study team
- Assesses adverse events

Determines severity and outcome of adverse events Determines relationship of adverse event to test article Ensures sponsor, IRB, etc. are notified of adverse event(s) as required by protocol or SOP Reports all serious adverse events immediately to the sponsor and IRB as outlined in the protocol
- Protects the rights and welfare of subjects

Provides new information about the study or test article(s)
- Ensure the validity of the data reported to the sponsor

Endorses changes or corrections to case report forms
- Ensures proper use and storage of investigational agents

Is thoroughly familiar with the Investigator brochure, use of the investigational product(s), and/or other source information Reviews the proper use of the study article(s) by the subject(s)
- Ensures documentation of study-related procedures, processes and events

Documents deviations from the approved protocol Documents that informed consent has been obtained from the subject or legal representative Ascertains the reason for a subject's premature study withdrawal Documents adverse experiences per protocol Complies with written procedures to document changes to data and/or case report forms
- Directs the conduct of the clinical trial

Communicates effectively with the research team, IRB, subjects and sponsors, as needed Meets regularly with the study team to discuss subject participation and protocol progress Attends investigator and study meetings Participate in monitoring visits and audits as appropriate
QUALIFITCATIONS

Licensed Dermatologist MD, FRCP

Demonstrated knowledge of Quality Standards and regulatory requirements

Cliantha Research is committed to creating and maintaining a diverse, inclusive, and accessible environment for all its employees and clients. We value diversity at workplace and believe in fostering a spirit of excellence brought in by all our employees and clients. If you require accommodation before, during, or after the interview/recruitment process do not hesitate to let us know when we contact you and we will work with you and do our level best to meet your needs.

We thank all our candidates for taking interest and the time to apply for stated job vacancy; however only those selected will be contacted for next steps.

Job Type: Part-time

Work Location: In person