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 principal investigator leads the medical and overall clinical study activities according to the most stringent regulatory regulations regarding risk- and safety management. 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 (SOPs), and in compliance with applicable scientific, ethical & regulatory regulations.
Main Accountabilities In the role of Principal Investigator (PI):
• Is 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; the PI is the key contact person for the Sponsor;
• Should intensively collaborate with the Clinical Research Coordinator, Laboratory Manager and other members of the study team and leads the team as the overall responsible of the team.
• Is the subject-matter expert, responsible for compliance with the internal quality system. Provides direction and actively contributes to developing, improving and implementing Standard Operating Procedures and Working Instructions. Notifies any violation or deviation to the immediate supervisor or appropriate authority.
Study-related activities as PI:
Study-related activities as PI:
• Oversees 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;
• Reviews and provides input to the trial protocol and informed consent form, and the trial setup in the eSource system;
• Signs off the study protocol and all (substantial) amendments to the study protocol (signature and date) and ensures that these documents are readily available for members of the study team;
• Identifies qualified (external) (Co-)Investigators for the completion of medical activities in the study and ensures that the collaboration between the physicians complies to the companies’ Health care Compliance procedures;
• Leads 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;
• Supervisor for dosing and responsible for the dosing procedures in the unit; • Documents 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;
• Reviews and evaluates data collection during the trial execution and actively participates in safety reviews and in data visualization meetings to support decisions on dose escalations;
• Ensures the safety and well-being of the volunteers;
• Prepares narratives if requested;
• 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;
• Authorized to legally sign for the compensation to be paid to volunteers and internal cost-estimates for his/her studies (only together with another authorized person in the department);
• Managing that all study-relevant documents are archived according to the CPU SOPs.
General activities of the PI:
• Develops a good working knowledge of all aspects of Phase I clinical research within the pharmaceutical industry and to coach less experienced staff;
• Develops a good working knowledge of study management and a full understanding of ICH-Good Clinical Practice;
• Develops a productive working relationship with hospital colleagues and with colleagues at the unit and other groups in the company to facilitate the acquisition of studies and the performance of duties and continued development as a Research Physician;
• Actively participates in the development, implementation and clinical validation of new methods and biomarkers;
• Becomes familiar with the practice of pharmaceutical medicine through the literature and by attending appropriate meetings and conferences;
• Liaises effectively with all members of the unit and makes a positive contribution towards team spirit in the unit;
• According to regulatory guidance documents, leads that CPU is compliant with national and international laws and regulatory guidelines, and laws on health and safety at work, fire prevention and other appropriate legislation;
• As a lead physician actively participates in the development of the department; • Liaises with external partners (e.g., Ethics Committee, Site Manager or monitor, Hospital Pharmacist, Sponsor, Physicians based in external Hospitals, etc.);• Actively participates in acquiring studies to the unit and in the screening of incoming study proposals for feasibility of trial execution by the unit; • Actively participates in the strategic discussions on study acceptance and workload distribution among the research physicians and other staff.
In the role of (Co-)Investigator: As Co-investigator, the PI will lead and if needed perform study related activities according to the clinical study protocol including, but not limited to:
• 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 protocolrequested 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;
• Compliance to safety procedures and environmental impacts within CPU and the company.
In the role of Safety Responsible Physician in Medical Monitoring activities:
As a Safety Responsible Physician, the research physician will:
• Provide input in protocol and ICF development, Clinical Study reports, DSUR
• Set up Medical Review Plan to ensure continuous Safety Monitoring • Attend PRC meetings, SIV meeting, Clinical Team meetings, Safety Management team meetings
• Primary point of contact for safety follow up with sites
• Continuous interaction with CPL, GCDO, DM and clinical team
• Leverage and share Clinical (Safety and Operational) and Pharmacology expertise
• Strengthen cross-departmental collaboration
• Provide input in Development Plan from early towards late development Note: When the research physician will perform medical monitoring activities in clinical trials conducted at the CPU, (s)he will report directly to the head of the unit during the duration of the clinical trial, to maintain independency. When medical monitoring activities are performed in clinical trials conducted at external sites, the reporting line remains to the medical director.
Other Accountabilities and Duties (if qualified)
• Actively contributes to developing and reviewing Standard Operating Procedures and Working Instructions in the role of process owner and subject matter expert (Electronic document system (EDMS)) Leads as business owner of certain Standard Operating Procedures and Working Instructions the regular update of these documents;
• Actively contributes to the validation and implementation of new systems, instruments methods and assessments;
• Leads and actively participates in the training and coaching of on-call staff and new and less experienced colleagues;
• Leads and actively contributes to scientific projects in close cooperation with colleagues inside and outside the unit;
• Is the system business owner for medical devices and systems and: o Assures that the systems meet the business process, regulatory and validation requirements; o Provides user training and ensures availability of documentations; o Ensures the availability of SOP’s and guidelines (work instruction) for system use; o Ensures controlled access to the system; o Evaluates and decides on recommended change actions; o Ensures that these systems are documented in the Validation Master Plan.
• Credo: liaises with all the members of the Department and makes a positive contribution towards team spirit in collaboration with the Credo Team.
• Leads, reviews and promotes all regulatory requirements as defined per the 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 necessary to perform the duties of the job;
• Ensures that assigned (on-call) staff complies with the training requirements necessary for specific tasks.
Responsibility for Others
• Team leader in the role of PI
• Responsible for the safety and well-being of the volunteer subjects
• Financial authority to Associate Director level
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 Work Experience
• Clinical experience is an important asset • Minimum of one year experience in the execution of phase I clinical studies
Minimal 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
• Computer literate
• Able to cope with administrative tasks
• Has an enquiring mind and genuine interest in clinical pharmacology, internal medicine, science and development of innovative drugs
Minimal Non-Technical 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
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.
Janssen Pharmaceutica N.V. (7555)