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.