Clinical Research Associate - Ghana

Clinical Research Associate – Ghana (home based and sponsor dedicated)

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

• The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, 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.
• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
• Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
• Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
• Provides regular site status information to team members, trial management, and updates trial management tools
• Completes monitoring activity documents as required by PRA SOPs or other contractual obligations
• Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
• Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed
• Performs essential document site file reconciliation
• Performs source document verification and query resolution
• Assesses IP accountability, dispensation, and compliance at the investigative sites
• Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines
• Communicates with investigative sites
• Updates applicable tracking systems
• Ensures all required training is completed and documented
• Serves as observation visit leader
• Facilitates audits and audit resolution
• Mentors junior level CRAs and serves as a resource for new employees

Experience  Required

• Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
• 1 year of on-site independent monitoring experience is essential. 
• A working knowledge of ICH-GCP guidelines and local and international regulatory requirements.
• You will be educated to degree level, have equivalent experience or be a licensed healthcare professional.
• Need to be based in Ghana with citizenship.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.