Senior Clinical Research Associate

We are looking for a Senior Clinical Research Associate for our operations in Mali.

Essential Functions and Other Job Information : 

1. Participation in feasibility studies with delegated task from FS responsible; approaching investigators and collects the requested information within the shortest possible timelines in compliance with all terms of confidentiality and current applicable SOPs.
2. Site selection and qualification evaluation.
3. Set-up of a study regarding submission and approval process and preparation of the documentation as per all applicable local requirements; keep EC and Regulatory authorities informed about study progress and changes.
4. Collect all ECs requirements per allocated studies.
5. Coordination, assistance (if needed) and participation in any trainings and meetings (incl. Investigator Meetings) related to the specific study.
6. Monitoring and quality control of the work of investigational sites; planning and performing monitoring visits in accordance with GCP and the study protocol and guidance. Strictly follows everything stipulated under ICH-GCP, point 5.18.
7. Review and reporting of all non-compliances/ protocol deviations, all AE/ SAEs to sponsor and taking the responsibility for accurate performing of SDV process, ensures proper transferring of CRF data to DM.
8. Reporting of trial progress to the CPM by writing reports and collecting trial specific data, keeping correspondence, participating in project meetings and teleconferences.
9. Ensuring the study is conducted in accordance with international and national regulatory requirements Protocol and applicable Quality Document (SOPs, WI, Plan, Manual, etc).
10. Organization and coordination of investigational products and other study supplies import and accountability as well as export of biological samples. This includes obtaining Import/Export License (if necessary), contacting the courier company,and coordinating study materials distribution via depot or directly to sites.
11. Providing any requested internal progress reports and completion of the relevant files.
12. Assists and follows the payment of investigator’s fees in collaboration with the Financial Sub-division.
13. Ensuring proper termination and performs any activities related to close out of all study sites and proper finalization of contracted tasks.
14. First line of communication for any study related issues arisen by sites for studies lead by them.
15. Able to conduct mostclinical monitoring activities effectively, efficiently with minimum supervision.
16. Timely coverage of all assigned trainings.
17. Adheres to the rules and regulations of ICH-GCP and other regulatory and ethical guidelines and data protection regulations.
18. Execute any activities in compliance with applicable SOPs, instructions,and principles.
19. Responsible for issues escalation following the proper escalation pathway.
20. Provide internal training to the team on a specific topic.

QualificationsEducation and Experience :

• University degree with life science background or equivalent and relevant formal academic/ vocational qualification.
• At least 4years of experience in the field of clinical research.
• Managing at least 2Interventional CT and covering all steps part of trial lifecycle (Qualification, successful study submission to IRB/RA, Initiation, Monitoring and Termination).
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 5years).
  In some cases,an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will beconsidered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities : 

• Excellent knowledge and practical aspects of implementation of ICH-GCP guidelines.
• Good working knowledge of Business English.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Basic medical terminology knowledge.
• A valid driving license and willingness to travel within the country and abroad (upon flexible working schedule).
• Good time management and multitasking skills to coordinate several studies simultaneously.
• Solid interpersonal skills.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Appropriate MS Office Skills.
• Good attention to detail.
• May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.
• Works with guidance or reliance on oral or written instructions frommanagement. May require periods of intense concentration.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
• Ability to perform under stress.
• Regular and consistent attendance.

Working Conditions and Environment : 

•  Work is performed in an office/ home-office environment with exposure to electrical office equipment.
• Often travels/ drives to site locations. Frequent travel both domestic and internation.