clinical research associate

Harrow, United Kingdom

Category Medical Sciences

Are you currently a non-First in Human (FIH), Principal Investigator (PI)?

Are you looking for a development opportunity to become PI, (FIH)?

We have an exciting opportunity for a PI whose primary responsibility will be to provide medical support for human volunteer studies of new and existing pharmaceuticals performed in an Early Phase Clinical Unit (EPCU) in Harrow. We are happy to support with the educational and training requirements associated with this position.

Key Accountabilities:

• To perform the duties of Principal Investigator on non-First in Human clinical trials according to International Conference on Harmonisation (ICH) Good Clinical Practice and to the highest standard to ensure that the welfare of the trial participants and the quality and credibility of study data is maintained.
• To provide medical support for human volunteer studies of new and existing pharmaceuticals performed in the London EPCU.
• To ensure that trial participants give fully informed consent in writing before commencing a study.
• To perform pre-study medical histories and medical examinations for studies performed in the London EPCU and to decide on a trial participant’s suitability for inclusion in a study and for joining the EPCU volunteer panel.
• To liaise with hospital specialists, GPs, consultants, and others to recruit suitable volunteers and patients for clinical trials.
• To assess and interpret study clinical data, e.g., Heart rates, BP, ECG’s, laboratory tests, adverse events etc.
• To monitor, interpret, communicate, and manage adverse events and other clinical data throughout studies.
• To be responsible for the quality of completion of appropriate sections of Case Report Forms.
• Meeting with Monitors and dealing with query resolution and clarifications appropriately.
• To prepare, review and QC safety reports for safety meetings.
• To perform clinical procedures as appropriate to each study
• To perform / assist in the administration of study medication

Department administration:

• To be involved in quality audits, QI management, root cause analysis and CAPA plans
• To be involved in SOP updates and processes
• To attend and be involved in study or corporate meetings

Training:

• To provide study specific training to the study team as appropriate, and delegate resources to the studies.
• Maintains own training and compliance as per role curriculum.
• Works towards obtaining FIH PI status

Knowledge/Skills & Experience:

• Preference for 4 years of experience in patient care post-medical qualification
• At least 18 months clinical experience and training in a phase 1 unit, with supervision by an experienced clinical pharmacologist / Phase1 Unit Medical Director highly advantageous
• Excellent interpersonal, verbal, and written communication skills
• A flexible attitude with respect to work assignments, new learning, and necessary shift work.
• Ability to work under pressure. Resilient to an unpredictable work shift pattern and dealing with interruptions.
• Willingness to work in a matrix environment and to value the importance of teamwork.
• Good written and spoken English

Education

• Medical Doctor with a full valid registration at the General Medical Council with license to practice
• Preferably attained at least one of the following:
  • Diploma in Pharmaceutical Medicine (DipPharm Med)
  • Member of the Faculty of Pharmaceutical Medicine (MFPM), FFPM or DCPSA
  • Medical research qualification, such as MD or PhD in pharmacology
  • Other relevant Human Pharmacology qualification
  • Other relevant post graduate medical qualification