Responsibilities:
- All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties.
- All aspects of site and registry management as prescribed in the project plans.
- Organize and make presentations at Investigator Meetings.
- Report, write narratives and follow-up on serious adverse events.
- Review progress of projects and initiate appropriate actions to achieve target objectives.
- You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required.
- Participate in the development of protocols and Case Report Forms as assigned.
- Interact with internal work groups to evaluate needs, resources and timelines.
Qualifications
- 5+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment.
- Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines.
- Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
- Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process.
- Good planning, organization and problem-solving abilities.
- Good communication and interpersonal skills.
Additional Information
All your information will be kept confidential according to EEO guidelines.
#J-18808-Ljbffr
