Likak Research recruits 01 Clinical Research Associate
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 selected candidate must be able to:
- Conduct monitoring visits at assigned sites for assigned protocols.
- Ensure that clinical research studies are conducted in accordance with the protocol, Standard Operating Procedures (SOP), Good Clinical Practices (GCP), and applicable regulatory requirements.
- Work in collaboration with other CRAs, under the leadership of the Likak Research Manager.
- Perform site monitoring visits in accordance with contracted scope of work and Good Clinical Practices.
- Provide monitoring visits for a variety of protocols, sites and therapeutic areas.
- Administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Escalate quality issues to Senior CRA, Likak Manager and/or Project Manager (PM).
- Manage the progress of assigned studies by tracking regulatory submission and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution.
- Create and maintains appropriate documentation regarding site management, monitoring visit findings and actions plans by submitting regular visit reports, generating follow-up letters and other required study documentation
- Act as a mentor for clinical staff.
- Any other task assigned by your immediate supervisor.
Reports to: Managing Director 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 both English and French language. Additional language is an asset.
- Excellent organizational and problem-solving skills.
- Effective time management skills.
- 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 onsite monitoring experience; or equivalent combination of education, training and experience
Fluency in English and French is required.
Not required, but considered an advantage: Resident in West Africa, ideally in Dakar.
All CVs and Motivation Letters should be sent to the following email: [email protected]
Location: Anywhere in Africa with regular travel, particularly in West and Central Africa.
Author: Likak Research Human Ressources
Closing date : 02 March 2022.