Regional Clinical Research Associate
Job Code: CSA0213
Major Responsibilities:
- Serving as principal communication link between the site staff and
company for the assigned sites
- Preparing clinical trial documentation for the initiation, conduct
and close out of clinical trials in the region
- Assisting in the preparation and coordination of documents required
for IEC/IRB submission and site / institution contracts to ensure study
timelines are met
- Modifying global documents according to the specific requirements of
the region/sites involved prior to submission to IRB/EC and other
external bodies in accordance to local requirements, ICH/GCP guidelines
and company’s SOPs/procedures.
- Creating a site trial plan, including recruitment strategy,
timelines and training site personnel on the trial specific
requirements, relevant guidelines/laws. allocated sites to the frequency
determined by the study team, assuring that the trial sites are
delivering high quality research
- Submitting a monitoring report to company after each site visit and
a contact report after all relevant telephone calls within the timelines
established by the study team and company’s SOPs/procedures
- Managing all site trial supplies including drug, laboratory and
study supplies such as CRFs (according to ICH/GCP guidelines/company
SOPs & Procedures) from receipt on site and/or in region, to collection,
reconciliation and destruction
- Assuring that trial drug supplies are properly handled, dispensed
and fully accountable throughout the trial
- Ensuring that the trial data is collected from the site in a timely
manner. Trial data has been reviewed on site for data integrity
(conducting source document verification), completeness and accuracy
- Ensuring Query resolution is complete and timely.
- Setting-up and maintaining the internal trial management systems
such as CADP
- Identifying potential and ongoing issues, discussing resolution
proposals proactively with the study team and ensuring resolution
- Assisting study team members to facilitate a successful completion
of the clinical program
- Attending project team meetings and teleconferences (as required)
- Reviewing AE reports (serious and non-serious) to ensure reporting
requirements are followed
- Ensuring that all weekly updates are obtained and communicated where
appropriate
- Maintaining written correspondence with sites
- Serving as a mentor to junior CRA’s
Education and Experience
- University degree in biological science and/or degree in Nursing
- 5 years clinical research experience in a CRO or Pharmaceutical
Company conducting CRA functions (on-site and in-house monitoring of
clinical trial)
- Strong knowledge of GCP/ICH guidelines and local guidelines, laws,
and requirements
- Good organizational skills, ability to work independently and as
part of a team and ability to provide support to junior staff
- Excellent communication, presentation skills, and interpersonal
skills
- Able to work within a multicultural environment and assertively deal
with difficult situations
- Sound computer and technical expertise
- Travel requirement: up to 80%
- Fluent in English and the local/regional language (additional
languages)
Reporting Requirements
The Clinical Research Associate reports to the Clinical Research
Associate Manager.
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