2 Clinical Research Associate Pharmaceutical Trials jobs in whatjobs
Clinical Research Associate - Pharmaceutical Trials
Posted 22 days ago
Job Viewed
Job Description
Our client, a pioneering pharmaceutical company at the forefront of medical innovation, is actively seeking a highly competent and dedicated Clinical Research Associate (CRA) to join their globally distributed, fully remote clinical operations team. This role is paramount in ensuring the successful execution of clinical trials in accordance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and protocol objectives. As a CRA, you will be responsible for monitoring clinical trial sites to ensure data integrity, patient safety, and adherence to study protocols. Your duties will include conducting pre-study visits, initiation visits, interim monitoring visits, and close-out visits for assigned clinical sites. You will verify the accuracy, completeness, and source data verification of clinical trial documentation, including patient records, lab results, and adverse event reporting. Building and maintaining strong relationships with investigators and site staff is crucial for fostering effective collaboration and ensuring compliance. This role requires a thorough understanding of clinical trial processes, regulatory frameworks, and ethical considerations in research. You will identify and report any deviations from protocol or GCP, escalate issues as needed, and implement corrective and preventive actions (CAPAs). Contributing to the development of study-related documents, such as protocols and case report forms, may also be part of your responsibilities. This fully remote position demands exceptional organizational skills, meticulous attention to detail, and the ability to work autonomously while collaborating effectively with internal study teams and external site personnel.
Key Responsibilities:
Key Responsibilities:
- Monitor assigned clinical trial sites to ensure compliance with protocol and GCP.
- Conduct pre-study, initiation, monitoring, and close-out visits.
- Verify accuracy and completeness of source data and CRFs.
- Ensure patient safety and rights are protected throughout the trial.
- Build and maintain strong relationships with investigators and site staff.
- Identify, document, and resolve protocol deviations and GCP non-compliance issues.
- Implement CAPAs and track their effectiveness.
- Ensure timely reporting of adverse events and safety information.
- Review and manage essential trial documents.
- Communicate effectively with study teams, sponsors, and regulatory authorities.
- Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
- Minimum of 3-5 years of experience as a Clinical Research Associate.
- In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
- Experience in site monitoring and clinical trial conduct.
- Strong understanding of medical terminology and disease states.
- Excellent critical thinking, problem-solving, and decision-making skills.
- Exceptional organizational, time management, and documentation skills.
- Proficiency with clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
- Excellent written and verbal communication skills.
- Ability to work independently and travel as needed (if applicable for site visits).
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Clinical Research Associate - Pharmaceutical Trials
Posted 11 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical innovator, is seeking a dedicated and experienced Clinical Research Associate (CRA) to join their cutting-edge research team. This is a fully remote position, empowering you to manage clinical trials from anywhere while making a significant impact on healthcare advancements. As a CRA, you will play a pivotal role in ensuring the quality, integrity, and compliance of clinical studies by monitoring investigational sites and verifying that data collected is accurate and complete. You will be responsible for site selection, initiation, monitoring, and close-out activities, ensuring adherence to Good Clinical Practice (GCP) guidelines and all applicable regulatory requirements. This role demands exceptional organizational skills, meticulous attention to detail, and strong interpersonal abilities to build and maintain effective relationships with investigators, site staff, and internal stakeholders. You will conduct source data verification, review case report forms (CRFs), and ensure timely reporting of adverse events. The ideal candidate possesses a strong background in clinical research, a deep understanding of pharmaceutical development, and a proven track record of successfully managing multiple study sites. A Bachelor's degree in a life science, nursing, or a related field is required, with advanced degrees being a distinct advantage. Previous experience as a CRA, preferably within a pharmaceutical or contract research organization (CRO) setting, is essential. Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS) is highly desirable. This role requires a proactive approach to problem-solving and a commitment to upholding the highest ethical standards in clinical research. As a remote employee, you will have the flexibility to manage your workload effectively while ensuring all monitoring activities are completed to the highest standards. Our client is dedicated to fostering a collaborative and innovative research environment.
Responsibilities:
Responsibilities:
- Perform site selection, initiation, interim monitoring, and close-out visits.
- Ensure study conduct is in compliance with protocol, GCP, and regulatory requirements.
- Verify source data and CRFs for accuracy, completeness, and consistency.
- Manage study supplies and investigational product accountability.
- Identify and report deviations and implement corrective actions.
- Serve as the primary liaison between study sites and the sponsor.
- Train site staff on study procedures and documentation.
- Participate in study team meetings and contribute to study progress reports.
- Bachelor's degree in Life Sciences, Nursing, or a related field.
- Minimum of 3 years of experience as a Clinical Research Associate.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
- Experience with EDC and CTMS systems.
- Strong monitoring and auditing skills.
- Excellent communication, negotiation, and interpersonal skills.
- Ability to travel to sites occasionally if required, although the role is primarily remote.
- Proficiency in English, both written and verbal.
This advertiser has chosen not to accept applicants from your region.
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