Research Physician Clinical Pharmacology Unit - Belgium
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Posted on : 08 March 2017
- The Research Physician participates 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.
- The Research physician(s) and other study team members are committed to produce high quality study data in accordance with the Unit’s Standard Operating Procedures, and in compliance with applicable scientific, ethical & regulatory regulations.
In the role of Principal Investigator (PI):
- To develop a good working knowledge of all aspects of Phase I clinical research within the pharmaceutical industry and to coach less experienced staff;
- To develop a good working knowledge of study management and a full understanding of ICH-Good Clinical Practice;
- To participate in clinical activities of the clinic including the medical screening of (healthy) volunteers & patients, dosing, ECG interpretation, etc.;
- Reviews and provides input in the trial protocol and informed consent form, and the trial setup in ClinBase™;
- Overseeing the preparation, review and approval of the required protocol documentation for filing to the Ethics Committee in compliance whit the Standard Operating Procedures, ICH-GCP guidelines and the requirements of the applicable authorities;
- The Principal Investigator (PI) is the key responsible in the execution of the clinical part of the protocol as preagreed with the sponsor; the PI is the key contact person to the Sponsor;
- The PI signs off the study protocol and all (substantial) amendments to the study protocol (signature and date);
- these documents should be readily available for members of the study team;
- The PI identifies qualified (external) (Co-)Investigators for the completion of medical activities in the study; the collaboration between the physicians should comply to the companies’ Health care Compliance procedures ;
- To review and evaluate the data collection during trial execution and to actively participate in safety reviews and in data visualization meetings in function of dose escalation;
- To prepare narratives if requested;
- The PI should intensively collaborate with the Clinical Research Coordinator, Laboratory Manager and other members of the study team;
- The PI is responsible for the dosing (procedures), drug accountability, IMP storage, and all documentation regarding study medication and preparation in the unit;
- The PI should document all raw, medical data according to the SOPs of the unit, and should control that all electronic systems that are being used during the study, are validated and operational;
- To assure the safety and well-being of the volunteers;
- To develop productive working relationship with hospital colleagues and with colleagues at the unit and other groups in the company to facilitate the attraction of studies and the performance of duties and continued development as Research Physician;
- To actively participate in the development, implementation and clinical validation of new methods and biomarkers;
- To become familiar with the practice of pharmaceutical medicine through the literature and by attending appropriate meetings and conferences;
- To liaise effectively with all members of the unit and take positive contribution towards team spirit in the unit;
- To comply with national and international laws and regulatory guidelines, and laws on health and safety at work, fire prevention and other appropriate legislation;
- To actively participate in the development of the department;
- Liaise with external partners (e.g. Ethics committee, Site Manager or monitor, Hospital Pharmacist, Sponsor, Physicians based in external Hospitals, etc.);
- To actively participate in attracting studies to the unit and in the screening of incoming study proposals for feasibility of trial execution by the unit;
- To actively participate in the strategic discussions on study acceptance and workload distribution among the research physician and other staff;
- The PI should sign off and date 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
- The PI should take care that all study-relevant documents are being archived according to the CPU SOPs.
In the role of (Co-) Investigator:
- Screening of (healthy) volunteers/patients regarding study eligibility;
- Performance of general and study-specific blood sampling procedures with or without specific catheters;
- Performance of study-specific tissue sampling procedures;
- Evaluation and documentation of clinical laboratory data, and requesting (a) re-test(s) if required
- Evaluation and documentation of ECGs, vital signs, and all protocol-requested measurements, and (a) requesting re-test(s), if required;
- Evaluation of all available data of volunteers/patients during screening and selection visits, and testing feasibility of candidate volunteer to participate in a clinical trial;
- Performance of study related anamnesis and physical & neurological examination of the volunteers according to study protocol, and evaluate all the data obtained;
- Informing of potential study volunteers to study details and putative risks, and arrange sign off of Informed Consent according to the SOPs of the CPU, ICH-GCP and local regulatory requirements;
- Responsible as (Co-) investigator for all medical actions and decisions during the study with focus on safety;
- Evaluation, managing and documenting of adverse events in clinical studies;
- Documenting and follow up of Serious Adverse Event(s) and SUSAR(s) according to companies’ SOP(s);
- Deciding whether or not to prescribe (which) co-medication, and to document 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;
- Compliance to safety procedures and environmental impacts within CPU and the company
Other Accountabilities and Duties (if qualified)
- Active contribution to developing and reviewing Standard Operating Procedures and Working Instructions in the role of process owner and subject matter expert (PharmaDoc).
- Active contribution to the validation and implementation of new systems, instruments methods and assessments;
- Active participation in the training and coaching of on-call staff and new and less experienced colleagues;
- Active contribution to scientific projects in close cooperation with colleagues inside and outside the unit;
- System business owner for medical devices and systems; to assure that the system meets the business process, regulatory and validation requirements, to assure user training and availability of documentations, to assure the availability of SOP’s and guidelines (work instruction) for system use, to assure controlled access to the system and to evaluate and decide on recommended change actions. These systems are documented in the Validation Master Plan;
- Observes and promotes all regulatory requirements as defined per applicable regulations rules and procedures established by the Company, and notifies any violation or deviation to the immediate supervisor or appropriate authority.
- Complies with all training requirements to perform duties of the job.
Responsibility for Others
- Team leader in the role of PI
- Responsible for the safety and well-being of the volunteer subjects
- Financial authority to the Manager/ Director level.
- Authorized to legally sign and check-up the amount of compensation to be paid to the volunteers (only together with another authorized person in the department).
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.
Minimal Skills, Knowledge and Qualifications
- Having an inquiring mind and genuinely interested in clinical pharmacology, internal medicine, science and development of innovative drugs.
- Enjoys practical medical work and contact with healthy volunteers and patients.
- Strong interpersonal skills
- Effective team leader
- Ability to work as part of a team
- Supervisor skills
- Good working knowledge of the ICH-GCP guidelines
- Good working knowledge of Basic Life Support
- Good working knowledge of Advanced Life Support
- Able to cope with administrative tasks
- Creative, flexible and having high ethical standards
- Meticulous attention to details
- Open to new concepts, innovation and change
- Computer literacy
- Fluent in written and spoken English
- Proficient in written and spoken Dutch
Minimal Work Experience
- Clinical experience is an important asset.
- Minimum of one year of experience in the execution of phase I clinical studies.
Minimal Non-Technical Competencies and Skills
- Building a successful team.
- Building strategic working relationships
- Coaching, Collaboration and innovation
- Continuous learning
- Customer focus
- Delivery of results
- Planning and organizing
- Quality Orientation / Attention to detail
- Technical/professional knowledge