Africa
Clinical Research Management Ltd (ClinicaIRM-Africa), an affiliate of Clinical
Research Management Inc. Ohio, USA is a Pan-Africa full service Contract
Research Organization (CRO) specializing in early to late stage clinical
research and product development for biologics, drugs and devices.
Clinical Research Associates
Working within a highly qualified team, the CRA will initiate and close-out investigational sites, monitor the progress of clinical studies at investigative sites, and ensure clinical trials are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOPs), ICH/GCP and all applicable regulatory requirements.
Responsibilities:
- Assess
the qualification of potential investigative sites, initiate clinical
trials at investigative sites, instruct site personnel on the proper
conduct of clinical trials, and close clinical trials at investigative
sites
- Implement
and monitor clinical trials to ensure sponsor and investigator obligations
are being met and are compliant with applicable local regulatory
requirements and ICH/GCP guidelines
- Review
and verify accuracy of clinical trial data collected, either onsite or
remotely
- Provide
regular site status information to team members, trial management and
update trial management tools
- Complete
monitoring activity documents as required by ClinicaIRM-Africa’s SOPs or
other contractual obligations
- Work
closely with clinical team members to facilitate timely resolution of
trial and/or clinical issues
- Assess
IP accountability, dispensation and compliance at the investigative sites
- Verify
Serious Adverse Event (SAE) reporting according to trial specifications
and ICH/GCP guidelines
- Communicate
with investigative sites
Qualifications:
- Undergraduate
degree or diploma or its international equivalent ¡n clinical, science, or
health-related field from an accredited institution
- Clinical
monitoring experience
- Knowledge
of ICH/GCP and local regulatory authority requirements
Interested candidates who meet the above criteria should send
their applications and CV electronically quoting the vacancy position on the
subject line of email to oapollo@clinicalrm.com not later than Friday, 10th
April 2015.
