241 Research And Development jobs in Gaydon

• Conduct site feasibility assessments and select appropriate clinical trial sites.
• Initiate, monitor, and close out clinical trial sites according to approved protocols and GCP guidelines.
• Perform on-site and remote monitoring visits to assess the progress of clinical trials, verify data integrity, and ensure compliance with regulatory standards.
• Train and support investigators and site staff on study protocols, procedures, and regulatory requirements.
• Manage communication between the sponsor and clinical trial sites, addressing any queries or issues promptly.
• Ensure timely collection, review, and reconciliation of clinical trial data and documentation.
• Oversee drug accountability and investigate any discrepancies.
• Prepare and submit monitoring reports, adverse event reports, and other essential study documentation.
• Identify potential risks and issues at clinical trial sites and develop appropriate mitigation strategies.
• Stay updated on relevant therapeutic areas, scientific advancements, and regulatory changes.
• Collaborate with internal teams, including project managers, data managers, and regulatory affairs specialists.
• Ensure compliance with all company policies, procedures, and ethical standards.
• Contribute to the development and improvement of clinical trial processes and documentation.

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline.
• Minimum of 5 years of experience as a Clinical Research Associate, with a proven track record in monitoring clinical trials.
• In-depth knowledge of ICH-GCP guidelines, clinical trial regulations, and drug development processes.
• Experience in therapeutic areas such as oncology, cardiology, or neurology is highly desirable.
• Excellent monitoring skills, with a keen eye for detail and accuracy.
• Strong understanding of clinical trial documentation and data management.
• Excellent communication, interpersonal, and presentation skills.
• Ability to work independently, manage time effectively, and travel as required for site visits.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Relevant professional certifications (e.g., ACRP, SoCRA) are a plus.

• Designing, optimizing, and executing complex in vitro and in vivo experiments to evaluate novel therapeutic agents.
• Developing and validating robust bioanalytical assays for drug quantitation and mechanism-of-action studies.
• Characterizing drug candidates' pharmacokinetic, pharmacodynamic, and toxicological profiles.
• Analyzing experimental data, interpreting results, and presenting findings at team meetings and scientific conferences.
• Contributing to the preparation of manuscripts, patents, and regulatory documents.
• Troubleshooting experimental issues and developing creative solutions to overcome research challenges.
• Staying current with scientific literature, emerging technologies, and industry trends in pharmaceutical R&D.
• Collaborating effectively with internal cross-functional teams and external partners.
• Mentoring junior research staff and contributing to a culture of scientific excellence.
• Maintaining accurate and detailed experimental records in compliance with GxP standards.

• Conduct site initiation, interim monitoring, and close-out visits for clinical trials in accordance with Good Clinical Practice (GCP) guidelines and company SOPs.
• Ensure accurate and timely collection of clinical data, verifying source documentation against case report forms (CRFs).
• Manage study sites, building strong relationships with investigators and site staff, and providing ongoing support and training.
• Monitor trial progress, identifying and resolving issues promptly to ensure patient safety and data integrity.
• Verify compliance with study protocols, regulatory requirements (e.g., FDA, EMA), and ethical principles.
• Prepare monitoring visit reports and ensure follow-up actions are completed.
• Maintain study documentation and electronic trial master files (eTMF) in an organized and up-to-date manner.
• Participate in protocol development, review, and finalization as needed.
• Contribute to the selection and qualification of clinical trial sites.
• Ensure timely reporting of adverse events and serious adverse events according to regulatory requirements.

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related discipline. A Master's degree is preferred.
• Minimum of 4-5 years of experience as a Clinical Research Associate, with a strong focus on oncology trials.
• In-depth knowledge of ICH-GCP guidelines, clinical trial processes, and regulatory requirements.
• Proven experience in conducting site monitoring visits and managing multiple clinical trial sites.
• Excellent understanding of medical terminology and disease states relevant to oncology.
• Strong organizational, time management, and problem-solving skills.
• Exceptional communication and interpersonal skills, with the ability to interact effectively with healthcare professionals.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to clinical sites as required (up to 50%).
• Certification from relevant professional bodies (e.g., ACRP, SoCRA) is a plus.

• Identify, assess, and select potential clinical trial sites.
• Initiate, monitor, and close-out clinical trial sites according to study plans and regulatory requirements.
• Conduct on-site and remote monitoring visits to verify data accuracy, patient safety, and protocol adherence.
• Ensure timely data collection and query resolution.
• Train and support site staff, including Principal Investigators and study coordinators.
• Maintain accurate and complete trial documentation, including source documents and case report forms (CRFs).
• Oversee site compliance with regulatory requirements (e.g., FDA, EMA) and company SOPs.
• Manage study supplies and investigational product accountability at sites.
• Identify and escalate site-related issues and risks to project management.
• Participate in study team meetings and contribute to protocol development and amendments.
• Prepare monitoring visit reports and follow up on action items.

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field; advanced degree is a plus.
• Minimum of 5 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical industry.
• Thorough understanding of GCP, ICH guidelines, and relevant regulatory requirements.
• Proven experience in monitoring Phase I-IV clinical trials.
• Excellent knowledge of clinical trial processes and documentation.
• Strong interpersonal, communication, and presentation skills.
• Ability to work independently, manage multiple priorities, and travel as required.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Detail-oriented with strong problem-solving abilities.
• Flexibility to adapt to changing project needs and work effectively in a hybrid environment.

• Conduct site selection, initiation, monitoring, and close-out visits for clinical trial sites.
• Ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements.
• Monitor data accuracy and integrity through source data verification and review of case report forms (CRFs).
• Build and maintain strong working relationships with investigators, study coordinators, and site staff.
• Manage and resolve site-level issues, escalating them as necessary.
• Prepare and present study-related information at investigator meetings.
• Contribute to the development of study protocols, informed consent forms, and other trial-related documents.
• Ensure timely submission of all required documentation to regulatory authorities and ethics committees.
• Oversee drug accountability and investigational product management at trial sites.
• Mentor and provide guidance to junior CRAs as needed.
• Manage site budgets and timelines effectively.
• Travel to clinical trial sites as required (typically 50-70%).

• Bachelor's degree in a life science, nursing, or related discipline.
• A minimum of 5 years of experience as a Clinical Research Associate.
• Demonstrated expertise in Oncology clinical trials.
• In-depth knowledge of ICH-GCP guidelines and relevant regulatory requirements (e.g., FDA, EMA).
• Proven experience in site monitoring, data verification, and regulatory compliance.
• Excellent communication, interpersonal, and negotiation skills.
• Strong organizational and time management abilities, with the capacity to manage multiple sites and priorities.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to work independently and as part of a team.
• Willingness and ability to travel extensively.
• A proactive approach to problem-solving and a commitment to quality.

• Conducting pre-study, initiation, interim, and close-out monitoring visits at clinical trial sites to assess study progress, regulatory compliance, and data integrity.
• Ensuring adherence to ICH-GCP guidelines, FDA regulations, and all applicable local regulatory requirements.
• Managing a caseload of investigational sites, providing support and guidance to site staff to ensure protocol compliance and efficient patient recruitment/retention.
• Reviewing and verifying source documents against case report forms (CRFs) to ensure data accuracy and completeness.
• Identifying, documenting, and resolving site-level issues and deviations in a timely and effective manner.
• Collaborating with the study team to develop and refine site monitoring plans.
• Building and maintaining strong, collaborative relationships with investigators, site staff, and internal project teams.
• Participating in the training of new CRAs and site personnel as needed.
• Contributing to the development of study-related documents, including protocols, informed consent forms, and monitoring reports.
• Ensuring the timely reporting of study progress, site performance, and any potential risks or issues to the Clinical Operations Manager.

• A Bachelor's degree in a life science, nursing, or related discipline, or equivalent relevant experience.
• A minimum of 5 years of direct experience as a Clinical Research Associate, with a significant portion focused on oncology trials.
• Comprehensive knowledge of ICH-GCP guidelines and other relevant regulatory requirements.
• Demonstrated experience in site management, monitoring, and data verification.
• Excellent communication, interpersonal, and organizational skills.
• Strong problem-solving abilities and a proactive approach to issue resolution.
• Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Ability to travel to investigational sites (approximately 50-60% travel anticipated).

Hybrid Test Development Engineer – Bicester, Oxfordshire

An excellent opportunity has arisen in Bicester, Oxfordshire for a Hybrid Test Development Engineer to join a forward-thinking engineering team. Reporting to the Senior Test Development Engineer, Team Leader, the Test Development Engineer will be responsible for developing and maintaining new testing methods to ensure consistent and cohesive testing across a broad product range.

The Test Development Engineer will contribute to the design and implementation of robust testing strategies, supporting the rollout of new methodologies and ensuring alignment with established testing standards. This role involves close collaboration with internal and external stakeholders to deliver high-quality, reliable test outcomes.

Key Responsibilities for the Test Development Engineer in Bicester, Oxfordshire

• Contribute to the design and development of a consistent systems-based approach to testing.
• Implement testing standards and train team members on new methodologies.
• Perform acceptance testing of new products and software prior to release.
• Analyse test performance, robustness, and efficiency, recommending improvements.
• Develop and implement tools, including automated test software, to improve throughput time.
• Conduct problem solving and support fault-finding of product failures.
• Review product definitions and requirements to ensure clear testing deliverables.
• Support testing and validation activities ahead of customer demonstrations.
• Produce, update, and maintain testing documentation, ensuring consistency and quality.
• Liaise with internal teams and external customers to provide technical testing support.
• Advise on replication of support issues and escalate testing concerns where appropriate.

Skills and Experience Required for the Test Development Engineer in Bicester, Oxfordshire

• Degree in Engineering (e.g., Maths, Physics) or equivalent technical background.
• Proven experience in a testing, development, or engineering environment.
• Strong analytical and problem-solving skills with a strategic mindset.
• Proficient in MS Office applications.
• Excellent attention to detail and a methodical, organised approach to work.
• Ability to work both independently with a high degree of autonomy and collaboratively in a cross-functional team.
• Strong interpersonal and communication skills.
• Hands-on, practical approach to problem solving.
• Experience producing and maintaining technical documentation is advantageous.

This position offers an exciting opportunity for a Hybrid Test Development Engineer looking to advance their career in a collaborative and innovative environment. Based in Bicester, this role provides the chance to make a meaningful impact on testing methodologies and product quality. APPLY NOW for more info. You can also contact Keelan Riley on or call for more information.