3 Senior Clinical Research Associate Pharmaceuticals jobs in whatjobs
Senior Clinical Research Associate - Pharmaceuticals
Posted 5 days ago
Job Viewed
Job Description
Our client, a leading global pharmaceutical company, is seeking a highly experienced Senior Clinical Research Associate (CRA) to join their fully remote clinical operations team. In this critical role, you will be responsible for overseeing and managing clinical trial sites, ensuring compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and study protocols. You will conduct site initiation visits, regular monitoring visits (remote and potentially on-site as needed), and site closure activities. Your primary objective is to ensure the quality, integrity, and accuracy of data collected during clinical trials. This is a remote-first position, requiring strong organizational skills, independence, and excellent communication abilities. You will serve as the primary point of contact for study sites, investigators, and site staff, providing guidance and support throughout the trial lifecycle. The ideal candidate possesses a strong background in clinical research, a deep understanding of pharmaceutical drug development, and a meticulous approach to data management and regulatory compliance. You will be expected to identify and escalate any site-level issues or deviations promptly. This role offers a unique opportunity to contribute to life-saving research from the convenience of your home office. We are committed to fostering a supportive and collaborative remote work environment for our clinical research professionals. Your dedication to scientific rigor and patient safety is paramount.
Responsibilities:
Responsibilities:
- Monitor clinical trial sites to ensure adherence to study protocols, GCP, and regulatory guidelines.
- Conduct site initiation, routine monitoring, and close-out visits (primarily remotely).
- Verify the accuracy, completeness, and integrity of clinical data collected at study sites.
- Manage and track study supplies and investigational product at trial sites.
- Train and support site staff on study procedures, data collection, and regulatory requirements.
- Identify, document, and resolve site-level issues and deviations.
- Communicate effectively with investigators, site personnel, and internal project teams.
- Prepare and submit monitoring visit reports in a timely manner.
- Ensure all regulatory documentation is maintained accurately at study sites.
- Contribute to the development of study-related documents, such as protocols and case report forms.
- Bachelor's degree in a life science, nursing, or related field. Advanced degree preferred.
- Minimum of 5 years of experience as a Clinical Research Associate in the pharmaceutical industry.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
- Proven experience in monitoring multiple clinical trials across different therapeutic areas.
- Excellent understanding of clinical trial processes and documentation.
- Proficiency with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Strong analytical, problem-solving, and decision-making skills.
- Exceptional communication, interpersonal, and organizational abilities.
- Ability to work independently and manage time effectively in a remote setting.
- A valid driver's license and willingness to travel occasionally for essential on-site visits (if required).
This advertiser has chosen not to accept applicants from your region.
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Senior Clinical Research Associate - Pharmaceuticals
Posted 12 days ago
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Job Description
Our client, a leading pharmaceutical innovator, is seeking a highly motivated and experienced Senior Clinical Research Associate (CRA) to join their dynamic, fully remote team. This role is integral to the successful execution of clinical trials, ensuring adherence to protocols, regulatory requirements, and ethical standards. The Senior CRA will be responsible for site selection, initiation, monitoring, and closing out clinical trial sites, meticulously documenting all trial-related activities. You will play a crucial role in data integrity, patient safety, and the overall progress of critical drug development programs. This is an exceptional opportunity to contribute to life-saving medical advancements from the convenience of your home office.
Key Responsibilities:
Key Responsibilities:
- Conduct site selection, initiation, monitoring, and close-out visits for clinical trials in accordance with protocol and GCP guidelines.
- Ensure timely and accurate data collection, verification, and source document review.
- Monitor patient safety and adverse event reporting.
- Verify compliance with study protocols, SOPs, and regulatory requirements.
- Build and maintain strong relationships with investigators, site staff, and study sponsors.
- Identify, evaluate, and resolve site-level issues and risks.
- Prepare and present site performance reports to study management.
- Ensure all trial-related documentation is maintained in the trial master file.
- Participate in study team meetings and contribute to protocol development as needed.
- Maintain up-to-date knowledge of regulatory guidelines and industry best practices.
This advertiser has chosen not to accept applicants from your region.
1
Senior Clinical Research Associate - Pharmaceuticals
Posted 7 days ago
Job Viewed
Job Description
Our client is actively seeking an experienced Senior Clinical Research Associate (CRA) to join their fully remote clinical operations team. This position plays a critical role in ensuring the successful execution of clinical trials for innovative pharmaceutical products. As a Senior CRA, you will be responsible for monitoring clinical trial sites, ensuring compliance with protocols, regulations, and Good Clinical Practice (GCP) guidelines. Your expertise in site management, data integrity, and regulatory adherence will be crucial for the success of our client's drug development programs. This is a remote-first opportunity, allowing you to contribute significantly to medical advancements from the comfort of your home.
Key Responsibilities:
Key Responsibilities:
- Conduct remote and on-site (as needed) trial-related monitoring visits to assess protocol adherence, patient safety, and data accuracy.
- Verify the collection, documentation, and reporting of clinical trial data; ensure data integrity and quality.
- Manage assigned clinical trial sites, serving as the primary point of contact for investigators and site staff.
- Ensure compliance with all applicable regulatory requirements, including ICH-GCP, FDA regulations, and local regulatory guidelines.
- Facilitate investigator meetings and training sessions on study protocols and procedures.
- Oversee site readiness, initiate sites, monitor site progress, and close out sites upon completion of the trial.
- Review and approve essential documents, including site regulatory binders and source documents.
- Identify and escalate potential issues and risks to clinical operations management and implement corrective action plans.
- Participate in the development and review of clinical trial protocols, case report forms (CRFs), and other study-related documents.
- Contribute to the development and implementation of risk-based monitoring strategies.
- Maintain effective communication with study teams, investigators, and internal stakeholders.
- Bachelor's degree in a life science, nursing, or related discipline. Advanced degree (Master's, PharmD, PhD) is a plus.
- Minimum of 5 years of experience as a Clinical Research Associate, with a strong understanding of pharmaceutical development.
- In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
- Proven experience in site monitoring, patient safety assessment, and data review.
- Excellent understanding of clinical trial processes from site selection to close-out.
- Strong organizational, time management, and problem-solving skills.
- Exceptional written and verbal communication skills, with the ability to effectively communicate with diverse stakeholders.
- Proficiency in using electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Ability to work independently and manage multiple projects simultaneously in a remote setting.
This advertiser has chosen not to accept applicants from your region.
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