Clinical Research Physician
About the role
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- Oversee safety issues of projects conducted by ICON which will include, but not be limited to, the following:
- Adverse event reporting to the sponsor
- Follow up of adverse events as necessary
- Communication of safety issues to the head of the department or designee
- Participate in the on-call system for providing 24/7 medical support
- Provide all necessary medical support functions as defined by project specific contractual obligations which will include, but not be limited to, the following:
- Medical information source
- Ongoing training for project teams in therapeutic areas as requested
- Review of study documentation (protocol, CRF. etc.)
- Contribute to investigator meeting presentations
- Ongoing safety review of individual patient laboratory reports generated by central laboratories
- CRF safety review
- Contribute any necessary medical input into integrated clinical and statistical reports
- Assist in making presentations to potential clients when appropriate
- Demonstrate a thorough understanding of ICON Standard Operating Procedures (SOPs) and ensure that all activities are conducted in accordance with current SOPs
- Demonstrate a thorough understanding of applicable regulatory standards in the country where clinical studies are to be conducted and ensure that all activities are conducted in compliance with current regulations
- Keep the person to whom the Clinical Research Physician reports informed of any issues within the department which require attention
- Line management of DSAs as appropriate
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
- MBBS degree in India
- Preferably experience in a relevant clinical research role
- Ability to medically evaluate clinical data
- Good oral and written communication skills including proficiency in English
- Ability and willingness to travel on an as-need basis
- Excellent presentation skills
- Good computer skills (MS: Outlook, Word, Excel)
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