If you are looking for a role which incorporates research and development of new pharmaceutical products along with career development, Clinical Research Biotechnology Jobs may be just what you are looking for.
Pre-clinical research may establish a promising New Clinical Entity (NCE). Before the drug goes to market a clinical research programme must be undertaken. There are several phases of clinical research with at least one study within each phase.
Phase 1– Studies involve the first exposure of a new compound to human subjects.Usually healthy volunteers. Ethics Committee approval required but not Regulatory Authority approval.
Phase 2– Studies are therapeutic, assess safety in small number of hospital patients with relevant illness. Ethics Committee and Regulatory Authority approval required.
Phase 3– Short and long-term safety in a large number of patients. EC and RA approval required. Phase 3 studies must be conducted in strict accordance with guidelines as they provide the data which determines if a drug is granted Marketing Authorisation to allow it to be marketed.
Phase 4– Studies conducted after Marketing Authorisation Application has been granted. Often coincide with launch of new drug on market.
Post Marketing Surveillance (PMS) are carried out to continue monitoring of drug safety to highlight any rare said effects which may come to light after large scale use.
Study protocols are drafted with input from regulatory experts, clinical research personnel, physicians etc. A steering committee may be set up to decide on the best study design. Content of the finalised protocol mirrored in design of Case Record Forms (CRFs), which are used by investigators to record patient data collected during the study.
Protocol goes through vigorous internal and external approval processes before it can go ahead. Before a new drug can progress to phase 2 and 3 of clinical research, the sponsor must notify the relevent Regulatory Authority, submitting the propsed protocol along with the drug and its performance in previous research. The regulatory body in the UK is the Medicine Control Agency (MCA).
Clinical research is also controlled by ethical restrictions. All studies must be approved by an independent ethics committee before patient recruitment can begin. The ICH Guidelines for good clinical practice (GCP) aim to set globally applicable standards for clinical studies in human subjects. Management of Clinical studies also governed Standard Operating Procedures (SOPs). Each company produces detailed written instructions to provide framework for conduct of study, thus encouraging consistent practice within GCP guidelines. Once the study is underway regular monitoring visits are made to ensure adherence to study protocol, GCP and SOPs. Audits often carried out by Quality Assurance personnel from the sponsor and / or contract organisation.
CRAs also known as Clinical Research Monitors, Clinical Research Executives, Clinical Research Scientists or Clinical Research Co-ordinators depending on the company.
They can be full-time or part time, field based or head office based. CRAs help design and monitor the clinical trials that test new medicines on humans. CRAs write the protocols which show exactly how the new medicines will be tested in the clinical trial as medicine storage conditions, age of people tested. Once a trial is underway, CRAs then monitorit to make sure the data collected is accurate and reliable.
CRAs can be involved in all phases of clinical research and at all stages of a particular study. Possible CRA activities include:-
An inexperienced CRA is most likely to be involved in the initiation, monitoring and close-out of a selected group of investigator centres. Data Management and Statistics personnel may assist in protocol and CRF development and later process and analyse the data delivered by the CRA.
CRA activities involve frequent travel (increasingly overseas) and included overnight stays. CRAs who are office based tend to focus on document review and management.
A clinical research study will be sponsored by the pharmaceutical company responsible for the drug which is to be studied. The sponsor will often organise and conduct a study using its own staff. However, the high cost of recruiting and training permanent staff, given the difficulties of predicting future workloads, means that the sponsor may enlist the services of a Contract Research Organisation (CRO). These CROs can:
A CRA position can therefore be within a pharmaceutical company or a CRO. A position within a CRO can be a stepping stone to a position with a pharma company. A CRA within a CRO can widen their experience with a number of different sponsor companies and across a number of different phases and therapeutic areas.
CRA Level 1 Most frequent activities involve regular visits to investigator centres. Have less involvement with activities such as protocol development.
CRA Level 2 Increasing level of responsibility with more involvement in activities such as protocol development. Can be responsible for all aspects of site management for a number of studies across a number of phases. Can become involved with document review and mentoring of junior CRAs.
CRA Level 3 / Senior CRA Increasing level of responsibility with more involvement in project management. Taking full responsibility for ethics, initiation, monitoring and close-out. Involvement with study management and staff training as well as contributing to the review of company procedures and process involvement.
Clinical Project Manager / Clinical Research Manager / Clinical Trial Management Leader / Clinical Manager A combination of managing the project as well as line management. Can also be at different levels eg. Clinical Project Manager 2, Senior Clinical Project Manager etc. Responsible for line management of a team of CRAs which can be UK and European based. Full responsibility for management of budgets, timelines, resourcing, client management, recruitment. If working for a CRO can also have a business development element to the role with responsibility for winning new business development element to the role with responsibility for winning new business and assisting with bid defence. Often a combination of operational, strategic and line management. A PhD tends to be an advantage for this level of position.
Candidates must have a life scienece degree or related medical qualification eg. RGN, Medical Doctor etc. Often candidates have a higher qualification MSc or PhD. A PhD can be very important when project management level is researched.
Useful experience includes:
Important personal attributes include:
The Regulatory Affairs Officer is the bridge between the Pharma company and the regulatory authorities. They can be involved in all development phases from NCE discovery to licence approval and beyond. They work on new Marketing Authorisation Applications as well as maintaining existing ones, including liaison with authorities over labelling and packaging changes. Regulatory depts. Have a major input in the drug development strategy, reviewing the programme of clinical studies to ensure that the appropriate and sufficient data is collected Regulatory Authority approval. The RA Officer’s job is in-house / head office based ad includes preparation of documentation for approval by the MCA which decides if further research or marketing of the new drug can go ahead. Also deal with international and European regulatory authorities such as FDA / EMEA. Also involved with maintaining and updating product licences.
Background experience and qualifications are usually similar to those of a CRA.
Previous experience is important.
Quality Assurance officer ensures that company SOPs are written followed and regulatory updated. QA officer will conduct audits in-house and at study centres, during which adherence to SOPs and country specific research laws or guidelines will be checked. Can be involved at all stages in the development, and marketing of drugs.
Eg. Some may work for companies who provide investigational drug labelling, packaging and distribution services to the pharma industry. Here they would need to assure the quality of products to Good Manufacturing Practice (GMP standards. Review documentation, records, protocols etc.
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