We are hiring a Clinical Trial Coordinator

We are hiring a Clinical Trial Coordinator!

 

The Clinical Trials Coordinator (CTC) is responsible for coordinating and managing the day-to-day running of allocated clinical trials, in accordance with International Conference on Harmonization Good Clinical Practices (ICH-GCP), applicable regulations and standard operating procedures (SOPs) and working instructions (WIs), under the supervision of the Clinical Study Manager (CSM).

 

Essential Duties and Responsibilities include, but are not limited to, the following:

  • Develop, implement and coordinate research and administrative procedures for the successful management of clinical trials. The CTC will perform diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study-specific protocols.
  • Prepare, write, adapt and/or perform Quality Control (QC) checks of study-level documents.
  • Perform administrative duties in study committees, where applicable, including preparing committee charters, meeting reports and agendas and write meeting minutes.
  • Liaise with research sites, Sponsors, CRAs/Monitors, Study Suppliers, Laboratories and other functional groups to obtain necessary and relevant information/documents and ensure timely delivery and quality of study deliverables throughout all stages of the life cycle of a clinical trial.
  • Aid the CSM and/or other relevant parties in writing, reviewing, and finalizing documents required for regulatory and ethical submission/approval/favourable opinion, including initial submission and amendments.
  • Aid the CSM and/or other relevant parties in the development of annual progression, safety and study close-out reports, as applicable.
  • Perform QC checks of all essential documents for filing in the Trial Master File (TMF). Prepare, maintain and perform QC of TMFs.
  • Assist in study archival procedures, as per applicable regulations and local SOPs.
  • Assist the CSM and/or other relevant parties in developing trial risk assessments and appropriate risk management measures.
  • Disseminate approved trial documents to appropriate parties, as applicable.
  • Establish and/or maintain processes/systems for tracking trial conduct and subject recruitment.
  • Assist and advise Data Managers/Programmers and the CSM in the development of Case Report Forms (CRFs) for the collection of study data.
  • Perform central and remote monitoring activities, as required.
  • Source, ordering and distribute clinical/trial supplies, as applicable.
  • Assist in pharmacovigilance reporting, as per regulatory requirements, study specifications and local SOPs.
  • Assist the CSM and/or other relevant parties in the detection of non-compliances, protocol deviations and in ensuring the implementation of appropriate corrective and preventive actions (CAPAs) and reporting, as per applicable regulations and local SOPs.
  • Coordinate processes associated with collection, shipping, analysis and reporting of study biological samples and other study clinical materials.
 
 

Basic Qualifications:

  • Degree in Health or Life Sciences (preferable: PhD)
  • Ideally 2+ years’ work experience in clinical trials performing the main duties described above in a CRO/pharma company/Clinical Trials Unit.
  • Previous clinical trials coordination experience in a related position
  • Knowledge of clinical trial and drug development processes
  • Knowledge of Good Clinical Practices (GCP) and regulatory requirements applied to clinical research
 

Highly desirable skills:

  • Ability to communicate and collaborate effectively with technical and senior management staff
  • Strong interpersonal skills and a positive attitude
  • Excellent written and verbal communication skills
  • Excellent attention to detail
  • Excellent administrative and IT skills
 
 
 

Please send CV to vectorb2b.hr@gmail.com

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