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Clinical Research Associate III

Publiée le 02.12.2022

Entreprise

Site Internet : https://pdc-cro.com/
Secteur d´activité :
Recherche et développement
Industrie pharmaceutique
Offres d´emploi : Voir toutes nos annonces
PDC is a full-service Contract Research Organization that is dedicated to provide Clinical ... lire la suite

Détails de l'annonce

Poste proposé : Clinical Research Associate III

Job description
Essential Functions and Other Job Information

1. Participation in feasibility studies with delegated task from FS responsible; approaching investigators and collecting 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 under supervision of senior personnel.

3. Assist during a study set-up regarding a submission and approval process and preparation of the documentation as per all applicable local requirements.

4. Collecting 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. Reviewing and reporting of all protocol deviations/ violations, 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 client 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. Ensuring proper termination and performs any activities related to close out of all study sites and proper finalization of contracted tasks.

13. First line of communication for any study related issues arisen by sites for studies lead by him/ her.

14. Execute any activities in compliance with applicable SOPs, instructions, and principles.

15. Responsible for issues escalation following the proper escalation pathway.

Profil recherché pour le poste : Clinical Research Associate III

Education and Experience

  • University degree with life science background or equivalent and relevant formal academic/vocational qualification.
  • At least 1 year of experience in the field of clinical research.
  • In case of internal promotion: successfully pass internal CRA assessment.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years)

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities

  • Good 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-theshelf
  • 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 from management. 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
Critères de l'annonce pour le poste : Clinical Research Associate III
Métier :
Management, direction générale
R&D, gestion de projets
Secteur d´activité :
Industrie pharmaceutique
Recherche et développement
Type de contrat :
Freelance
Région :
Bamako - Gao - International - Kayes - Mopti - Sikasso - Taoudeni
Niveau d'expérience :
Expérience entre 2 ans et 5 ans
Niveau d'études :
Bac+4
Langues exigées :
anglaisbon niveau
Compétences clés :
management
time management
gestion
compliance
assessment
Nombre de poste(s) : 2
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