|Likak Research recruits 01 Clinical Trial Assistant|
Description de l’offre
Clinical Trial Assistant
• Santé & Social
Likak Research recruits a Clinical Trial Assistant.
About Likak Research
Likak Research is a Clinical Research Organization (CRO) based in West Africa and established to provide Clinical Research services to pharmaceutical, biotechnology, medical device companies and health institutions.
The company offers professional, innovative and effective services related to Phase I-IV Clinical research namely –but not limited to- Site selection, coordination and Monitoring, Ethics and Regulatory applications, Electronic archiving of clinical trial documents, Data management, budget negotiation and trial site team’s training in sub-Saharan Africa.
Our vision is to bring our contribution to the global efforts in Africa and in developing countries in the field of clinical research in particular, and Health in general, so that all kinds of work is conducted according to international standards.
Scope of role
The Clinical Trial Assistant (CTA) is responsible for project-supporting clinical drug research and development tasks. She/he will work closely with CRAs (Clinical Research Associates), who monitor the progress of the study, as well as Clinical Project Managers. She/he will also be responsible for maintaining the complete documentation for the studies assigned with the aim of ensuring complete and correct study administration in accordance with the SOPs (Standard Operating Procedures), Good Clinical Practices (GCP), and applicable regulatory requirements.
• Maintain and update all clinical systems and monitor all performance within timeframe and prepare all documents for operating procedures and evaluate all documents.
• Maintain effective receipt of all regulation documents from the study site.
• Assist to ship all drugs and resolve all issues in financial documents and prepare reports for all invoices and maintain inventory of all non-drug clinical supplies.
• Gather and monitor all financial files for SOP and plan various study meetings and participate in associate meetings to provide support and document all clinical study reports electronically.
• Coordinate with various study sites and evaluate the same on a periodic basis to ensure accuracy in the same and prepare and distribute all clinical trial supplies and maintain the same.
• Coordinate with various departments to label and distribute all clinical supplies appropriately and approve all vendor designs for trials and determine required protocol for all packaging designs and evaluate all records for contractors.
• Manage and track all Case Report forms for clinical data efficient flow and manage all project communication and prepare required documents and maintain contact list for trials.
• Administer all clinical trials and ensure compliance to schedule and formal all trial newsletters and track all legal documents and achieve the same.
• Monitor and gather information for all insurance requirements of trail and coordinate with various departments to prepare study budget management.
Reports to: Clinical Research Associate of Likak Research
Required knowledge, skills and abilities
• In depth knowledge of, and skill applying, applicable clinical research regulatory requirements; i.e Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• In depth therapeutic and protocol knowledge as provided via company training
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint, virtual meeting software and use of laptop computers.
• Strong written and verbal communication skills, including good command of English and French language.
• Excellent organizational and problem-solving skills.
• Effective time management skills.
• Knowledge of Medical Terminology.
• Ability to manage competing priorities.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• Ability to travel on a regular basis to visit sites.
Qualifications and experience
Bachelor’s degree in a health care or other scientific discipline or educational equivalent
• Minimum of 3 years of CTA experience, onsite monitoring experience; or equivalent combination of education, training and experience
Fluency in both English and French is required.
All CVs and Motivation Letters should be sent to the following email indicated..
Location: Senegal with intermittent travel in West and Central Africa.
Closing date : 02 March 2022.
COMMENT POSTULER ?
All CVs and Motivation Letters should be sent to the following email: [email protected]