Clinical Trial Physician
Johnson & Johnson
Antwerp, Belgium
5 dagen geleden

Position Objective As a Research Physician you participate as principal or co-investigator in the safe, efficient and effective execution of clinical studies as part of the study team of the Clinical Pharmacology Unit (CPU).

As a principal investigator, you lead the medical and overall clinical study activities according to the most stringent regulatory regulations regarding risk- and safety management.

You are committed to produce high quality study data in accordance with the Unit’s Standard Operating Procedures (SOPs), and in compliance with applicable scientific, ethical & regulatory regulations.

Main Accountabilities In the role of Principal Investigator (PI) :

  • You are the key person medically leading the CPU study Team and responsible for the execution of the clinical part of the protocol as pre-agreed with the sponsor;
  • You are the key contact person for the Sponsor;
  • You collaborate intensively with the Clinical Research Coordinator, Laboratory Manager and other members of the study team and lead the team as the overall responsible of the team.
  • You are the subject-matter expert, responsible for compliance with the internal quality system. You provide direction and actively contributes to developing, improving and implementing Standard Operating Procedures and Working Instructions.
  • You notifiy any violation or deviation to the immediate supervisor or appropriate authority.

    Study-related activities as PI :

  • You oversee the preparation, review and approval of the required protocol documentation for filing to the Ethics Committee in compliance with the Standard Operating Procedures, ICH-GCP guidelines and the requirements of the applicable authorities
  • You will review and provide input to the trial protocol and informed consent form, and the trial setup in the eSource system
  • You will sign off the study protocol and all (substantial) amendments to the study protocol (signature and date) and ensure that these documents are readily available for members of the study team
  • You identify qualified (external) (Co-)Investigators for the completion of medical activities in the study and ensuree that the collaboration between the physicians complies to the companies’ Health care Compliance procedures
  • You lead the clinical activities of the clinic including the medical screening of (healthy) volunteers and patients, dosing, ECG and vital signs interpretation, and other protocol-requested measurements
  • You are the supervisor for dosing and responsible for the dosing procedures in the unit
  • You document all raw, medical data according to the SOPs of the unit, and ensures that all electronic systems being used during the study, are validated and operational
  • You evaluate data collection during the trial execution and actively participate in safety reviews and in data visualization meetings to support decisions on dose escalations
  • You ensure the safety and well-being of the volunteers
  • Signs off and dates the Final Study Report to approve the scientific and medical integrity of the data and the outcome of the study in compliance with current GCP procedures
  • You are authorized to legally sign for the compensation to be paid to volunteers and internal cost-estimates for his / her studies
  • You manage that all study-relevant documents are archived according to the CPU SOPs.
  • Responsibilties in the role of (Co-)Investigator :

  • Screening of (healthy) volunteers / patients regarding study eligibility
  • Blood sampling and tissue sampling
  • Evaluation and documentation of clinical laboratory data, ECGs, vital signs, and other protocol-requested measurements
  • Evaluation of all available volunteer / patient data during screening and selection visits, and testing of the feasibility of candidate volunteers to participate in a clinical trial
  • Performance of study related anamnesis and physical and neurological examination
  • Informing potential study volunteers of the study details and putative risks, and arranging sign off of Informed Consent according to the SOPs of the CPU, ICH-GCP and local regulatory requirements
  • Responsibility as (Co-)investigator for all medical actions and decisions during the study with a focus on safety
  • Evaluation, management and documentation of adverse events in clinical studies
  • Documenting and following up of Serious Adverse Event(s) and SUSAR(s) according to company SOP(s)
  • Deciding whether or not to prescribe (which) co-medication, and documenting the use of this medication
  • Liaising on a regular basis with the sponsor (safety experts) regarding study progress and study safety observations
  • Preparation of (Interim) Safety Reports and active participation in study team meetings and / or Data Safety Monitoring Board meetings to discuss and agree on dose escalation and implementation of stopping rules
  • Qualifications

    Minimal Educational Background and Qualifications

  • Medical degree preferably recognized by the Physicians’ Board Belgium ( Orde der Geneesheren )
  • Clinical electrocardiography certificate and Advance Life Support are strong assets
  • Medical specialization is an asset Work Experience
  • Clinical experience is an important asset
  • Experience in the execution of phase I clinical studies is a plus
  • Technical Skills, Knowledge and Qualifications

  • Good working knowledge of the ICH-GCP guidelines and other relevant regulatory guidelines and regulations
  • Good working knowledge of Basic Life Support and of Advanced Life Support
  • Basic knowledge of project management
  • Able to apply technical / professional knowledge to the execution of clinical trials
  • Fluency in written and spoken English
  • Proficiency in written and spoken Dutch
  • Has an enquiring mind and genuine interest in clinical pharmacology, internal medicine, science and development of innovative drugs Competencies and Skills
  • Strong organizational, operational and management skills
  • Strong written, verbal and interpersonal communication skills
  • Able to prioritize and multi-task
  • Able to establish and maintain effective working relationships
  • Good accuracy and attention to detail
  • Results driven
  • Pro-active and creative in identifying and solving problems
  • Interested in early clinical research, practical medical work and contact with healthy volunteers and patients
  • Minimal Other Requirements

    Willingness and ability to be flexible with work hours and when necessary to work outside office hours to facilitate protocol requirements and / or to guarantee the safety of the volunteers or patients.

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