The Role of a Clinical Research Physician...
Clinical Research Physicians sit in the heart of clinical development teams either within a pharmaceutical company or a Clinical Research Organisation (CRO). Such a role would focus on guiding a product through the development stages of clinical pharmacology and Phase I, or Phase II or Phase III. With the exception of Phase I trials, direct patient contact is rare for Clinical Research Physicians. A Research Physician will work within a team to design and implement clinical trial plans. Once the trial is underway there will then be a responsibility to carry out on-going trial safety monitoring work - to ensure Good Clinical Practice (GCP) and other compliance procedures are adhered to, in addition to ensuring the integrity of clinical trial data.
Depending on which phase of development the Clinical Research Physician has a focus on, typical responsibilities may include (but are not limited to):
- Ensuring that clinical trial related procedures are conducted and completed in line with ICH-GCP guidelines
- Working with the Principal Investigator to record and deliver trial research data
- Reporting any Adverse Event (AE) or Serious Adverse Event (SAE) data in line with ICH-GCP guidelines
- Working directly with on-site Clinical Research Associates to ensure trial and data integrity, including conducting site monitoring visits
- Attending regular meetings, such as:
- Investigator meetings
- Study initiation meetings
- Study site selection visits
- Sponsor and/or regulatory audits
- Reviewing Investigator brochures and draft trial protocols
- Being present at ethics committee meetings (if your team manages a study under review)
- Reviewing the medical records of potential study volunteer candidates
- Reconciling study documentation
- Reviewing medical and laboratory reports as required
- Handling potential patient complaints in line with a company’s Standard Operating Procedures (SOPs)
- Developing a patient recruitment plan and working with the trial recruitment team to implement that strategy
Within clinical research, a Pharmaceutical Physician usually progresses by taking on wider and more decision-making responsibility for a group of trials or a project. Alternatively, they may become a development subject-matter expert for a particular therapy area or product at a company. Similarly to medical affairs, a career in development may see a Pharmaceutical Physician progress to a Research Director who is responsible for project teams or a regional/global therapy area Director who will oversee part if not all of a drug’s development cycle.