2 Clinical Research Associate Pharmaceuticals jobs in whatjobs
Clinical Research Associate - Pharmaceuticals
Posted 7 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical research organization, is seeking a diligent and experienced Clinical Research Associate (CRA) to join their fully remote team. In this critical role, you will be responsible for monitoring clinical trials, ensuring data integrity, and verifying compliance with protocols and regulatory guidelines. Your expertise will be crucial in advancing the development of life-saving medications. This position demands a thorough understanding of Good Clinical Practice (GCP), clinical trial conduct, and excellent interpersonal skills.
Key Responsibilities:
Key Responsibilities:
- Conduct site initiation visits, interim monitoring visits, and close-out visits for clinical trials, ensuring adherence to study protocols and regulatory requirements.
- Verify the accuracy, completeness, and integrity of clinical trial data by reviewing source documents and case report forms (CRFs).
- Ensure all trial-related activities and documents are in compliance with Good Clinical Practice (GCP), FDA regulations, and other applicable guidelines.
- Monitor patient safety and report any adverse events or protocol deviations according to established procedures.
- Build and maintain strong working relationships with investigators, site staff, and other study stakeholders.
- Provide training and ongoing support to clinical trial sites on study procedures and data collection.
- Manage study supplies and equipment at clinical sites, ensuring proper storage and handling.
- Prepare and submit monitoring visit reports in a timely manner, documenting findings and action items.
- Track and resolve data queries and discrepancies identified during monitoring.
- Ensure timely retrieval and archiving of all essential study documents.
- Participate in investigator meetings and clinical trial team discussions.
- Stay updated on current regulatory requirements and industry best practices in clinical research.
- Bachelor's degree in a life science, nursing, or related field.
- Minimum of 3-5 years of experience as a Clinical Research Associate or in a similar clinical trial monitoring role.
- In-depth knowledge of GCP guidelines, ICH regulations, and clinical trial conduct.
- Experience with various therapeutic areas is a plus.
- Strong understanding of clinical trial protocols and study documentation.
- Excellent organizational, time management, and prioritization skills.
- Exceptional attention to detail and accuracy in data review.
- Outstanding communication, interpersonal, and problem-solving skills.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently, travel as required (if applicable, though this role is remote), and manage responsibilities effectively in a remote setting.
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Clinical Research Associate - Pharmaceuticals
Posted 6 days ago
Job Viewed
Job Description
Our client is seeking a meticulous and experienced Clinical Research Associate (CRA) to join their fully remote pharmaceutical team. This role is critical in managing and monitoring clinical trials to ensure the safety, efficacy, and integrity of new pharmaceutical products. You will be responsible for overseeing all aspects of clinical study conduct at investigator sites, including site initiation, monitoring, and close-out. The ideal candidate will have a strong understanding of Good Clinical Practice (GCP) guidelines, regulatory requirements, and clinical trial processes. This is a remote-first position, requiring excellent organizational, analytical, and communication skills to effectively manage relationships with investigators, site staff, and internal stakeholders. You will conduct site visits (as needed, often virtually) to verify data accuracy, ensure protocol compliance, and address any study-related issues. Responsibilities include reviewing source documents, Case Report Forms (CRFs), and study logs; resolving data queries; and ensuring that all trial activities are conducted in accordance with the approved protocol and applicable regulations. A Bachelor's degree in a life science, nursing, or a related field is required; a Master's degree is a plus. A minimum of 3-5 years of experience as a CRA or in a similar clinical research role within the pharmaceutical industry is essential. Strong knowledge of drug development processes and therapeutic areas is highly desirable. You must be proficient in using electronic data capture (EDC) systems and other clinical trial management software. Excellent written and verbal communication skills, strong problem-solving abilities, and the capacity to work independently and manage multiple projects simultaneously are paramount. This is an excellent opportunity to contribute to the development of life-saving medications from the comfort of your home, with a competitive salary and comprehensive benefits.
This advertiser has chosen not to accept applicants from your region.
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