Dermatologist/consultant
6 months ago
Cliantha is currently seeking a 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 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, Winnipeg & Scarborough) & Europe (Portugal).
The primary responsibility of the Investigator 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 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
- 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
- Ensures documentation of study-related procedures, processes and events
- Documents deviations from the approved protocol
- 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
- 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._
Work remotely
- No
**Job Type**: Part-time
Schedule:
- On call
**Education**:
- Master's Degree (preferred)
Licence/Certification:
- Dermatologist certification (required)
Work Location: In person
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