8 Senior Clinical Research Associate Cra jobs in whatjobs
Senior Clinical Research Associate (CRA)
Posted 22 days ago
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Job Description
Our client, a globally recognized pharmaceutical company, is seeking an experienced Senior Clinical Research Associate (CRA) to join their clinical operations team. This role is based in Nakuru and requires the candidate to be present at specific research sites. You will be responsible for monitoring clinical trials to ensure they are conducted, recorded, and reported in accordance with the study protocol, company policies, and all applicable regulatory requirements. Your duties will include site selection, initiation, monitoring, and close-out visits; ensuring the quality and integrity of data collected; managing investigational product accountability; and serving as the primary liaison between the sponsor and the clinical sites. The ideal candidate will have a Bachelor's degree in a life science or related field, a minimum of 5 years of experience as a CRA, and a thorough understanding of ICH-GCP guidelines and regulatory requirements. Strong communication, organizational, and problem-solving skills are essential. You must be proficient in medical terminology and possess excellent attention to detail. While this role is not remote, it offers the opportunity to work on cutting-edge clinical research and contribute to the development of life-changing therapies. Travel to clinical trial sites within the region will be required. We are looking for a dedicated professional who is passionate about advancing medical science and ensuring patient safety. Your commitment to upholding the highest standards of clinical research conduct will be critical. Join a leading pharmaceutical organization and play a vital role in bringing innovative treatments to market. This is an excellent opportunity for a motivated CRA to further their career in a challenging and rewarding environment. You will have the chance to build strong relationships with investigators and site staff, fostering a collaborative approach to clinical research.
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Senior Clinical Research Associate (CRA)
Posted 6 days ago
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Job Description
Our client is seeking a highly experienced Senior Clinical Research Associate (CRA) to join their pharmaceutical team. This role will involve monitoring and managing clinical trials to ensure they are conducted, recorded, and reported in accordance with the study protocol, standard operating procedures (SOPs), and regulatory requirements. While this position offers a hybrid work model, requiring occasional on-site visits, a significant portion of the role can be performed remotely. The ideal candidate will possess a strong understanding of clinical trial processes, excellent communication skills, and a meticulous approach to data accuracy and patient safety.
Key Responsibilities:
Key Responsibilities:
- Conduct site visits (initiation, routine monitoring, close-out) to assess protocol and regulatory compliance, ensuring data integrity and patient safety.
- Verify the accuracy and completeness of source data and other clinical information against Case Report Forms (CRFs).
- Ensure investigational product accountability and management at study sites.
- Train and support site staff on protocol requirements, study procedures, and data collection.
- Serve as the primary point of contact between the sponsor and clinical trial sites.
- Identify and report any deviations from protocol, regulatory requirements, or SOPs.
- Assist in the resolution of data discrepancies and queries.
- Prepare and present study progress reports to the sponsor and study team.
- Ensure all study-related documentation is maintained in accordance with regulatory standards.
- Participate in investigator meetings and provide training on study conduct.
- Manage multiple clinical trial sites concurrently, ensuring efficient study progression.
- Adhere to all company policies and procedures, as well as relevant ethical and regulatory guidelines (e.g., ICH-GCP).
- Contribute to the development and review of study protocols and other essential documents.
- Maintain strong working relationships with principal investigators, site staff, and other stakeholders.
- Identify potential risks to study timelines or data quality and propose mitigation strategies.
- Bachelor's degree in a life science, nursing, pharmacy, or related scientific discipline.
- Minimum of 5 years of direct experience as a Clinical Research Associate, with a strong understanding of GCP guidelines.
- Proven experience in conducting site monitoring visits, including initiation, routine, and close-out visits.
- Proficiency in medical terminology and understanding of clinical trial methodologies.
- Experience with electronic data capture (EDC) systems and electronic trial master files (eTMF).
- Excellent written and verbal communication skills.
- Strong organizational and time management skills, with the ability to prioritize effectively.
- Ability to travel to clinical sites as required (approximately 40-60% travel expected).
- Proficiency in relevant software applications, including MS Office Suite.
- Detail-oriented with a commitment to accuracy and quality.
- Ability to work independently and as part of a collaborative team.
- Professional certifications (e.g., ACRP, SoCRA) are a plus.
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Senior Clinical Research Associate (CRA)
Posted 5 days ago
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Job Description
Our client, a leading pharmaceutical company committed to advancing global health, is searching for an experienced Senior Clinical Research Associate (CRA) to join their expanding remote clinical operations team. This position is critical for overseeing and managing clinical trials across various therapeutic areas, ensuring compliance with all regulatory requirements and ethical standards. As a Senior CRA, you will be responsible for site selection, initiation, monitoring, and close-out activities, as well as ensuring data accuracy and integrity throughout the trial. You will conduct on-site and remote monitoring visits to assess protocol adherence, review patient records, and verify source data. This role requires a deep understanding of Good Clinical Practice (GCP), regulatory guidelines (FDA, EMA, etc.), and clinical trial processes. The ideal candidate will have a strong background in pharmaceutical or biotechnology industries, with a proven track record of successfully managing multiple complex clinical trials. Excellent communication, negotiation, and problem-solving skills are paramount, along with the ability to build and maintain strong relationships with investigators, site staff, and internal stakeholders. This is a remote-first opportunity, offering the flexibility to manage your workload and travel effectively from your home base. You will be expected to travel to study sites as needed. We are looking for a highly organized, self-motivated individual who can work independently and contribute to the overall success of our clinical development programs. This role presents a significant opportunity for professional growth and impact within a supportive and scientifically driven organization.
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Senior Clinical Research Associate (CRA)
Posted 4 days ago
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Job Description
Our client, a leading pharmaceutical company, is seeking a dedicated and experienced Senior Clinical Research Associate (CRA) to oversee and manage clinical trials. This role requires a blend of on-site engagement and remote flexibility. You will play a critical role in ensuring the safety and integrity of trial data, adhering to strict regulatory guidelines, and contributing to the successful execution of clinical development programs. The ideal candidate possesses strong organizational skills, a meticulous attention to detail, and a comprehensive understanding of Good Clinical Practice (GCP) and regulatory requirements.
Responsibilities:
Responsibilities:
- Monitor clinical trial sites to ensure compliance with protocols, SOPs, and GCP guidelines.
- Verify the accuracy, completeness, and integrity of clinical data through source data verification (SDV).
- Identify, evaluate, and train potential clinical trial sites and investigators.
- Manage relationships with investigators and site staff, providing ongoing support and guidance.
- Ensure timely and accurate entry of data into clinical databases.
- Prepare and present trial status updates to internal stakeholders and investigators.
- Manage investigational product accountability and drug dispensing at trial sites.
- Identify and report adverse events and serious adverse events in a timely manner.
- Contribute to the development and finalization of clinical trial protocols and other study documents.
- Ensure all site activities are conducted in accordance with the clinical trial protocol and regulatory requirements.
- Resolve site-specific issues and implement corrective action plans as needed.
- Contribute to the close-out of clinical trial sites, ensuring all necessary documentation is complete and archived.
- Maintain up-to-date knowledge of relevant regulations and industry best practices.
- Bachelor's degree in a life science, nursing, pharmacy, or a related discipline. Advanced degree is a plus.
- Minimum of 3-5 years of experience as a Clinical Research Associate (CRA) or in a similar clinical trial management role.
- Thorough understanding of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
- Proven experience in site monitoring, including pre-study visits, initiation visits, routine monitoring, and close-out visits.
- Excellent communication, interpersonal, and negotiation skills.
- Strong organizational and time management abilities, with the capacity to manage multiple tasks and priorities.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to clinical trial sites as required for monitoring activities.
- Problem-solving skills with a proactive approach to identifying and resolving issues.
- Must be detail-oriented and committed to data accuracy and patient safety.
This advertiser has chosen not to accept applicants from your region.
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Senior Clinical Research Associate (CRA)
Posted 12 days ago
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Job Description
Our client, a leading pharmaceutical company dedicated to advancing healthcare, is seeking a highly skilled and experienced Senior Clinical Research Associate (CRA) to join their fully remote global clinical operations team. This critical role focuses on ensuring the successful execution of clinical trials, adhering to strict regulatory guidelines and protocols. While the operational focus may touch upon the region of Nakuru, Nakuru, KE , the position itself is entirely remote, enabling top talent to contribute from anywhere in the world. You will be responsible for monitoring clinical trial sites, ensuring data integrity, patient safety, and compliance with Good Clinical Practice (GCP) and other applicable regulations. This involves conducting site initiation visits, routine monitoring visits, and site closure visits. The Senior CRA will also play a key role in training and supporting site staff, resolving issues, and maintaining effective communication between the trial sites and the sponsor. We are looking for an individual with extensive experience in clinical research, a deep understanding of regulatory requirements (FDA, EMA, ICH-GCP), and a proven ability to manage multiple complex trials simultaneously. Strong organizational, analytical, and problem-solving skills are essential. Excellent communication, interpersonal, and negotiation skills are crucial for building rapport with investigators, site staff, and internal teams in a remote setting. Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS) is required. A Bachelor's degree in a life science or healthcare-related field is mandatory; a Master's degree or equivalent is advantageous. This is an exceptional opportunity to make a significant impact on the development of new therapies while enjoying the flexibility of a fully remote work environment. If you are a meticulous, proactive, and dedicated CRA ready to take on new challenges, we encourage you to apply.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Conduct site initiation, routine monitoring, and close-out visits for clinical trials.
- Ensure study conduct is in compliance with the protocol, GCP, and applicable regulations.
- Verify the accuracy, completeness, and integrity of clinical trial data.
- Monitor patient safety and report adverse events according to protocol.
- Build and maintain strong working relationships with investigators and site staff.
- Train site personnel on study procedures, protocols, and regulatory requirements.
- Resolve site-specific issues and escalate complex problems as needed.
- Manage investigational product accountability and study supplies.
- Ensure proper documentation and maintenance of essential study documents.
- Prepare monitoring reports and communicate findings to the clinical operations team.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 5 years of experience as a Clinical Research Associate (CRA).
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
- Experience with various therapeutic areas is a plus.
- Proficiency in using EDC systems and CTMS software.
- Strong monitoring, auditing, and problem-solving skills.
- Excellent written and verbal communication skills.
- Ability to work independently and manage time effectively in a remote setting.
- Strong organizational skills and meticulous attention to detail.
- Willingness to travel occasionally (if required, though role is primarily remote).
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Senior Clinical Research Associate (CRA)
Posted 13 days ago
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Job Description
Our client is a leading global pharmaceutical company at the forefront of medical innovation, dedicated to improving patient outcomes through groundbreaking research and development. We are seeking a highly experienced and meticulous Senior Clinical Research Associate (CRA) to join our esteemed, fully remote clinical operations team. This critical role will involve overseeing and managing various aspects of clinical trials, ensuring compliance with all regulatory requirements and ethical standards. You will be responsible for site selection, initiation, monitoring, and close-out visits, as well as ensuring the accuracy, completeness, and integrity of clinical data. The ideal candidate will possess a comprehensive understanding of Good Clinical Practice (GCP) guidelines, FDA regulations, and other relevant international standards. Key responsibilities include training and mentoring junior CRAs, developing study protocols and case report forms (CRFs), and liaising effectively with investigators, site staff, and internal project teams. You will also be involved in data analysis review and the preparation of study reports. This position requires exceptional organizational skills, strong attention to detail, and the ability to manage multiple priorities in a fast-paced environment. Excellent verbal and written communication skills are essential for clear and effective interaction with all stakeholders. A Bachelor's degree in a life science, nursing, or a related field is required; an advanced degree is a plus. A minimum of 5-7 years of progressive experience as a CRA is mandatory, with a demonstrated history of successfully managing complex clinical trials. Experience in specific therapeutic areas, such as oncology, cardiology, or neurology, is highly desirable. This is a fantastic opportunity to contribute to the development of life-saving therapies and advance your career within a world-class pharmaceutical organization, all from the convenience of your remote workspace. We are committed to fostering a collaborative and supportive remote work culture, enabling our team members to excel and make a significant impact on global health.
This advertiser has chosen not to accept applicants from your region.
5
Senior Clinical Research Associate (CRA)
Posted 21 days ago
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Job Description
Our client, a prominent pharmaceutical company, is seeking an experienced Senior Clinical Research Associate (CRA) to join their growing clinical operations team. This role offers a hybrid work arrangement, combining remote flexibility with necessary on-site visits to clinical trial sites. You will be responsible for the overall management and monitoring of clinical trials at assigned investigational sites, ensuring compliance with protocol, Good Clinical Practice (GCP) guidelines, and all applicable regulatory requirements. The ideal candidate will possess a strong understanding of clinical trial processes, from site selection and initiation to monitoring and close-out. Key responsibilities include conducting pre-study visits, site initiation visits, routine monitoring visits (both on-site and remote), and site close-out visits. You will also be responsible for ensuring accurate and timely data collection, managing site personnel, and resolving any issues that arise during the trial. Strong communication, organizational, and problem-solving skills are essential for success in this role. You will work closely with investigators, site staff, and internal project teams to ensure the successful execution of clinical trials. This is a demanding but rewarding position for a dedicated professional who is passionate about advancing pharmaceutical research and development. We are looking for individuals who are meticulous, possess excellent interpersonal skills, and have a proven ability to manage multiple priorities effectively. A commitment to ethical research conduct and patient safety is paramount.
Responsibilities:
Responsibilities:
- Plan, manage, and monitor clinical trial sites to ensure compliance with protocol, GCP, and regulatory requirements.
- Conduct site qualification, initiation, interim monitoring, and close-out visits.
- Ensure timely and accurate collection of clinical trial data.
- Verify source documentation against case report forms (CRFs).
- Manage site staff and facilitate effective communication between sites and the sponsor.
- Identify, document, and escalate site-level issues and deviations.
- Oversee drug accountability and ensure proper investigational product management.
- Prepare monitoring visit reports and follow up on action items.
- Assist in the resolution of data queries and ensure data integrity.
- Maintain a strong understanding of therapeutic areas and study protocols.
- Contribute to the development of study-related documents.
- Build and maintain strong relationships with investigators and site personnel.
- Bachelor's degree in a life science, nursing, or related field; higher degrees preferred.
- Minimum of 5 years of experience as a Clinical Research Associate.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
- Experience in monitoring multiple clinical trials across different therapeutic areas.
- Strong understanding of clinical trial processes and documentation.
- Excellent communication, interpersonal, and organizational skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to clinical sites as required (up to 60%).
- Strong problem-solving and decision-making abilities.
- Detail-oriented with a high level of accuracy.
- Self-motivated and able to work effectively both independently and as part of a team.
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6
Senior Clinical Research Associate (CRA)
Posted 5 days ago
Job Viewed
Job Description
Our client, a dynamic and rapidly expanding pharmaceutical company dedicated to improving global health outcomes, is seeking a highly motivated and experienced Senior Clinical Research Associate (CRA) to join their on-site team. This role is integral to the successful execution of clinical trials, ensuring adherence to rigorous protocols and regulatory standards. You will be responsible for monitoring investigational sites, verifying the accuracy and completeness of clinical data, and ensuring patient safety throughout the trial process. Your duties will include conducting pre-study, initiation, interim, and close-out visits; managing study supplies; and serving as the primary point of contact between study sites and the sponsor. This position requires extensive travel to investigational sites, fostering strong relationships with investigators and site staff. Key responsibilities involve ensuring compliance with Good Clinical Practice (GCP) guidelines, applicable regulations, and study-specific procedures; identifying and resolving site-level issues; and meticulously documenting all trial-related activities. The ideal candidate possesses a strong understanding of clinical trial methodologies, therapeutic areas, and regulatory requirements (e.g., FDA, EMA, ICH-GCP). A Bachelor's degree in a life science, nursing, or a related field is required, with advanced degrees or relevant certifications being a plus. Minimum of 3-5 years of experience as a CRA, demonstrating proficiency in site monitoring and data review, is essential. Excellent communication, organizational, and problem-solving skills are paramount. You must be detail-oriented, able to manage your time effectively, and comfortable working independently in a field-based role. This position requires a dedicated professional committed to contributing to the development of life-changing pharmaceuticals through meticulous and ethical clinical trial conduct. While this role is not remote, it offers significant opportunities for professional growth and development within a supportive and innovative pharmaceutical environment.
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