Susan Murray at CK Clinical is looking for a Senior Clinical Research Associate to join a major pharmaceutical company based in East Yorkshire, UK. This is a permanent position.
As Senior Clinical Research Associate, you will be responsible for providing clinical input to designated Pharmaceutical Category Products through specification of clinical trial requirements and protocols and management of clinical trials. Further responsibilities of this role include:
- Working in multi-functional project teams providing clinical input to deliver project requirements.
- Representing the company in the external environment, working with CROs, KOLs, Regulators etc as required to optimise project development strategies.
- Negotiating costs and managing payments for Clinical Trials in remit
- Providing clinical expertise to the design of clinical trials, ensuring trial designs are appropriate to achieve the desired claims and to suggest innovative approaches to achieving the desired endpoints.
- Ensuring that all protocols developed for pharmaceutical clinical trials address the business requirements and are fully compliant with all relevant legal and regulatory requirements and SOPs.
- Ensuring that all clinical trials/studies are performed to the required timelines.
- Ensuring that the relevant Clinical Affairs SOPs are implemented for all clinical trials/studies.
- Ensuring that Investigators and Contract Research Organisations appointed to conduct clinical trials/studies are suitably qualified and experienced and to oversee the conduct of clinical trials/studies, ensuring that the required quality standards are met.
- Reviewing, revising and writing standard operating procedures to ensure adherence to Good Clinical Practices in the conduct of Reckitt Benckiser sponsored studies.
- Participating in meetings and conference calls with multidisciplinary study teams and vendors.
- Liaising with quality assurance and provide input and review on data management activities.
- Assessing potential study sites and CROs to insure that facility, staff, and patient populations meet Reckitt Benckiser’s study needs.
- Planning and executing study start up meetings.
- Reviewing and finalising clinical monitoring reports and report to project teams any significant issues.
- Meeting with clinical investigators and their staff to insure that all aspects of the study are understood, and all required documentation is complete before initiating the study.
- Managing Clinical Research Associates (in-house or contract) to monitor study progress to assure compliance with protocol requirements, applicable FDA/ICH regulations, Good Clinical Practices, and contractual agreements; review and verify monthly contractor invoices.
- Managing Clinical Research Associates (in-house or contract) to ensure clinical supplies and test articles for appropriate storage, full drug accountability, proper destruction at the end of the study, and ensure that no product is diverted to an inappropriate use.
- Conducting audits that include source document review, and insure timely, accurate, and complete CRF collection during the study and at study completion.
- Ensuring adverse events are filed appropriately with Pharmacovigilance.
- Assisting the clinical sites in preparing for possible FDA inspection.
The ideal candidate:
To be considered for this Clinical Research Associate role you will possess:
- The ability to work effectively with minimal supervision and capability to multitask and move competently among various tasks.
- An In-depth understanding of current Good Clinical Practices and regulations relating to clinical research.
- Clinical development experience in a pharmaceutical development environment.
- Strong and well developed motivational and interpersonal skills.
- A clear and logical thinker with the ability to recognise patterns and develop innovative solutions.
- Ability to develop and communicate argumentation in order to influence externally and internally.
- Flexibility of thinking in order to facilitate working with many different professional disciplines.
- Pro-active self-direction with a high level of initiative and persistence.
- Understanding priority setting and project management.
- Strong analytical skills with the ability to implement plans.
- Strong communication skills, both written and oral.
- A willingness to explore new and previously uncharted territories and an openness to change and ability to think out of the box.
- Results oriented, entrepreneurial and self-motivating.
- The capability to build strong working relationships to deliver outstanding results.
- BA/BS (or advanced degree), preferably in a scientific discipline relevant to health sciences
- A minimum of 5 years of clinical research experience, two of which must have been as a Clinical Research Associate.
- Experience in study design, scientific methods, and field monitoring practices from drug/medical device development.
- Certification by the Association of Clinical Research Professionals or a similar organization.
- Experience managing CRAs and CROs.
- This position requires travel (up to approximately 30%).
How to apply:
For more information, or to apply for this Clinical Research Associate position, please contact Susan Murray at CK Clinical on 01438 743 047 or email email@example.com.