679 Senior Cra jobs in the United Kingdom
Clinical Research Associate (CRA)
Posted today
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Job Description
Key Responsibilities:
- Monitor clinical trial sites to ensure adherence to protocol, GCP, and regulatory requirements.
- Perform site initiation visits, routine monitoring visits, and close-out visits.
- Verify accuracy and completeness of clinical trial data through source data verification.
- Ensure proper documentation and maintenance of essential trial documents.
- Serve as the primary contact for study sites, providing support and training to investigators and staff.
- Oversee patient recruitment and retention efforts at assigned sites.
- Report site findings and escalate issues as necessary to project management.
- Ensure subject safety and data integrity throughout the trial lifecycle.
- Prepare monitoring reports and track action items.
Qualifications:
- Bachelor's degree in life sciences, nursing, or a related field.
- Proven experience as a Clinical Research Associate.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
- Excellent understanding of clinical trial processes.
- Strong monitoring skills, including source data verification.
- Exceptional organizational and communication skills.
- Ability to travel to clinical sites as required.
Clinical Research Associate (CRA)
Posted 1 day ago
Job Viewed
Job Description
Key Responsibilities:
- Initiate, monitor, and close-out clinical trial sites according to protocol, GCP, and regulatory guidelines.
- Conduct site visits (initiation, interim, and close-out) and document findings accurately.
- Ensure data integrity and patient safety by reviewing case report forms (CRFs) and source documents.
- Verify compliance with the study protocol, regulatory requirements, and company Standard Operating Procedures (SOPs).
- Manage and maintain essential study documents, ensuring they are up-to-date and accessible.
- Build and maintain strong working relationships with investigators, site staff, and study participants.
- Identify and report any deviations, adverse events, or protocol violations in a timely manner.
- Oversee drug accountability and investigational product management at study sites.
- Provide training and ongoing support to site personnel regarding study procedures.
- Act as a primary point of contact for assigned study sites, resolving queries and issues efficiently.
- Contribute to the development and review of study-related documents, including protocols and CRFs.
- Prepare and present site monitoring reports to management and relevant stakeholders.
- Ensure all study activities are conducted ethically and in accordance with the highest quality standards.
- Bachelor's degree in a life science, nursing, or related field; advanced degree is a plus.
- Minimum of 2-3 years of experience as a Clinical Research Associate or in a similar clinical trial management role.
- Thorough understanding of ICH-GCP guidelines and regulatory requirements for clinical trials.
- Proven experience in site monitoring, data review, and regulatory compliance.
- Excellent organizational, time management, and problem-solving skills.
- Strong written and verbal communication abilities.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to clinical sites as required (estimated X% of the time).
- Self-motivated, detail-oriented, and capable of working independently within a hybrid framework.
- Demonstrated ability to build rapport and foster effective relationships with healthcare professionals.
Clinical Research Associate (CRA)
Posted 2 days ago
Job Viewed
Job Description
Responsibilities:
- Monitor assigned clinical trial sites to ensure compliance with study protocols, SOPs, and GCP.
- Verify the accuracy, completeness, and integrity of clinical data through source document review.
- Ensure the safety and rights of study participants are protected.
- Conduct site initiation, routine monitoring, and close-out visits.
- Build and maintain strong working relationships with investigators and site staff.
- Review and approve regulatory documents submitted by study sites.
- Manage drug accountability and investigational product supplies at sites.
- Identify and resolve site-level issues and deviations promptly.
- Train site staff on study-specific procedures and regulatory requirements.
- Prepare and submit accurate monitoring visit reports in a timely manner.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Previous experience as a Clinical Research Associate or in a similar clinical trial monitoring role.
- Thorough understanding of GCP, ICH guidelines, and regulatory requirements.
- Excellent organizational, time management, and problem-solving skills.
- Strong written and verbal communication skills.
- Ability to travel to assigned clinical sites as needed.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Detail-oriented with a commitment to data accuracy and patient safety.
Clinical Research Associate (CRA)
Posted 2 days ago
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Job Description
Clinical Research Associate (CRA)
Posted 2 days ago
Job Viewed
Job Description
Clinical Research Associate (CRA)
Posted 2 days ago
Job Viewed
Job Description
As a CRA, you will play a crucial role in the successful execution of clinical trials, ensuring adherence to protocols, regulatory requirements, and Good Clinical Practice (GCP) standards. You will be responsible for monitoring clinical trial sites, verifying data integrity, and managing study documentation to ensure patient safety and data accuracy.
Key Responsibilities:
- Conduct site initiation, interim monitoring, and close-out visits in accordance with study protocols and SOPs.
- Verify the accuracy, completeness, and integrity of clinical data by reviewing source documents and case report forms (CRFs).
- Ensure compliance with study protocols, regulatory guidelines (FDA, EMA, ICH-GCP), and company policies.
- Manage study-related activities and documentation, including investigational product accountability and subject recruitment.
- Build and maintain strong relationships with investigators, site staff, and study participants.
- Identify and report protocol deviations, adverse events, and serious adverse events in a timely manner.
- Train site personnel on study procedures, protocol requirements, and data collection.
- Prepare monitoring visit reports and communicate findings to study teams and management.
- Ensure site readiness for regulatory audits and inspections.
- Contribute to the development and review of clinical study protocols and other study documents.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Proven experience as a Clinical Research Associate or in a similar clinical trial monitoring role.
- Thorough understanding of ICH-GCP guidelines and relevant regulatory requirements.
- Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Excellent organizational skills with the ability to manage multiple priorities effectively.
- Strong attention to detail and accuracy in data verification.
- Proficient in written and verbal communication, with strong interpersonal skills.
- Ability to travel to clinical sites as required (estimated at 50-60% travel).
- A valid driver's license and a clean driving record are essential.
- Prior experience in specific therapeutic areas (e.g., oncology, cardiology) is a plus.
Clinical Research Associate (CRA)
Posted 3 days ago
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Job Description
Responsibilities:
- Initiate, monitor, and close-out clinical trial sites according to Good Clinical Practice (GCP) and regulatory requirements.
- Conduct site visits (pre-study, initiation, routine monitoring, and close-out) to assess the quality and integrity of data and compliance with the protocol.
- Ensure subject safety and data accuracy by reviewing source documents, Case Report Forms (CRFs), and other study-related data.
- Train and support site staff on study procedures, protocol requirements, and regulatory compliance.
- Build and maintain strong relationships with investigators, site staff, and internal project teams.
- Identify and report any adverse events or protocol deviations promptly.
- Manage study supplies and investigational product at clinical sites.
- Prepare monitoring visit reports and ensure timely follow-up on action items.
- Contribute to the development and review of study-related documents, including protocols and Case Report Forms.
- Stay abreast of relevant regulatory guidelines and industry best practices.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related discipline. A Master's or PhD is a plus.
- Minimum of 3 years of direct CRA experience, with a strong understanding of clinical trial processes.
- Thorough knowledge of GCP, FDA regulations, and other relevant regulatory guidelines.
- Excellent communication, interpersonal, and organizational skills.
- Ability to travel as required (estimated 30-50%).
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Strong critical thinking and problem-solving abilities.
- Demonstrated ability to work independently and manage a remote workload effectively.
- Valid driver's license and passport.
- This is a remote role, supporting clinical trials nationwide, with occasional visits to sites across the Manchester, Greater Manchester, UK region and beyond.
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Clinical Research Associate (CRA)
Posted 4 days ago
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Job Description
Key Responsibilities:
- Conduct site initiation visits (SIV), routine monitoring visits (IMV), and close-out visits (COV) for clinical trial sites.
- Ensure compliance with study protocols, standard operating procedures (SOPs), and all applicable regulatory requirements (e.g., ICH-GCP, FDA, EMA).
- Verify accuracy and completeness of source documentation against case report forms (CRFs).
- Monitor patient safety and safety reporting as per protocol and regulatory guidelines.
- Train and educate site personnel on study requirements and procedures.
- Maintain effective communication and collaboration with investigators, site staff, and internal project teams.
- Manage investigational product supplies and accountability at study sites.
- Oversee resolution of data queries and ensure timely data retrieval.
- Prepare and submit monitoring visit reports in a timely manner.
- Ensure timely archiving of essential trial documents.
Qualifications:
- Proven experience as a Clinical Research Associate (CRA) or similar role in the pharmaceutical or biotech industry.
- In-depth knowledge of clinical trial processes, GCP, and regulatory guidelines.
- Strong understanding of medical terminology and therapeutic areas.
- Excellent monitoring skills, attention to detail, and problem-solving abilities.
- Exceptional written and verbal communication skills.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel frequently to clinical trial sites in and around Sheffield, South Yorkshire, UK .
- A relevant scientific or healthcare degree (e.g., Nursing, Pharmacy, Life Sciences).
- Ability to work independently and manage multiple priorities effectively.
- Commitment to ethical conduct and patient well-being.
This is a challenging yet rewarding opportunity for a dedicated CRA looking to make a tangible difference in healthcare. Join our team in Sheffield, South Yorkshire, UK .
Clinical Research Associate (CRA)
Posted 5 days ago
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Job Description
Key Responsibilities:
- Perform site selection, initiation, monitoring, and close-out visits in accordance with the Clinical Monitoring Plan.
- Ensure the quality and integrity of data collected at clinical trial sites.
- Verify the accuracy and completeness of source documentation against the Case Report Forms (CRFs).
- Monitor compliance with the study protocol, SOPs, and regulatory requirements.
- Manage communication between the investigational sites and the study team.
- Resolve data discrepancies and ensure timely query resolution.
- Ensure the accurate and timely submission of safety reporting information.
- Train and support site staff on study-specific procedures and GCP.
- Manage investigational product accountability and storage at trial sites.
- Build and maintain strong working relationships with site personnel and investigators.
- Prepare visit reports and follow up on action items.
Clinical Research Associate (CRA)
Posted 9 days ago
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