6 Lead Clinical Research Associate jobs in whatjobs
Lead Clinical Research Associate
Posted 14 days ago
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Job Description
Our client, a leading pharmaceutical entity, is actively recruiting for a Lead Clinical Research Associate to bolster their research and development endeavors. This role offers a hybrid work arrangement, allowing for a balance between remote flexibility and in-office collaboration. The Lead CRA will be responsible for overseeing and managing clinical trial activities, ensuring adherence to Good Clinical Practice (GCP) guidelines, regulatory requirements, and study protocols. This involves site selection, initiation, monitoring, and close-out visits, as well as ensuring data integrity and patient safety. You will mentor and guide junior CRAs, providing training and support to ensure high performance standards across the team. This position demands a deep understanding of pharmaceutical development, clinical trial processes, and data management. The successful candidate will possess excellent communication and interpersonal skills, with the ability to effectively liaise with investigators, site staff, and internal stakeholders. You will be involved in protocol development, case report form (CRF) design, and the preparation of regulatory submissions. Risk assessment and mitigation strategies for clinical trials will also fall under your purview. Proactive problem-solving and a results-oriented approach are essential. This role contributes significantly to bringing life-saving and life-enhancing medications to market. The ideal candidate will have a strong scientific background and a proven track record in clinical research. This position is located in Mlolongo, Machakos, KE , and operates on a hybrid model.
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Lead Clinical Research Associate
Posted 20 days ago
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Job Description
Our client, a progressive pharmaceutical company, is seeking a highly experienced Lead Clinical Research Associate (CRA) for a fully remote position. This critical role involves overseeing and managing clinical trials, ensuring adherence to protocols, regulatory requirements, and ethical standards. The ideal candidate will possess extensive experience in clinical trial management, including site monitoring, data collection oversight, and regulatory submissions within the pharmaceutical or biotech industry. Strong leadership skills and the ability to mentor and guide junior CRAs are essential. As a remote CRA, you will conduct remote monitoring of study sites, engage with investigators and study staff via virtual platforms, and ensure the integrity and accuracy of trial data. Your responsibilities will include developing study protocols, managing investigational product logistics, ensuring subject safety, and facilitating timely completion of trials. You will also be responsible for performing risk-based monitoring, preparing monitoring reports, and resolving site-specific issues. The ability to work autonomously, manage multiple priorities effectively, and maintain meticulous documentation in a remote setting is crucial. This is an outstanding opportunity for a seasoned CRA to take on a leadership role, contributing to life-saving research and development efforts that impact public health, remotely supporting trials relevant to **Naivasha, Nakuru, KE**, and global health outcomes.
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Lead Clinical Research Associate
Posted 12 days ago
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Job Description
Our client, a pioneering pharmaceutical company dedicated to advancing global health, is actively seeking an experienced Lead Clinical Research Associate (CRA) for a fully remote, high-impact role. You will be at the forefront of our clinical development efforts, overseeing multiple clinical trials from initiation to closure. This position requires exceptional organizational skills, a meticulous attention to detail, and a comprehensive understanding of Good Clinical Practice (GCP) guidelines and regulatory requirements. As a Lead CRA, you will play a critical role in ensuring the safety of study participants and the integrity of the data collected across various therapeutic areas.
Responsibilities:
Qualifications:
Responsibilities:
- Lead and manage a team of CRAs, providing guidance, mentorship, and performance feedback.
- Oversee all aspects of clinical trial conduct, including site selection, initiation, monitoring, and close-out.
- Ensure compliance with study protocols, SOPs, GCP, and applicable regulatory requirements.
- Conduct site visits (remote and potentially on-site as needed) to assess protocol compliance, data accuracy, and patient safety.
- Manage communication between investigative sites, project teams, and regulatory authorities.
- Develop and review study-related documents, including monitoring plans, case report forms (CRFs), and essential documents.
- Identify, evaluate, and manage clinical trial sites, ensuring their suitability for study participation.
- Troubleshoot and resolve issues that arise during clinical trial conduct.
- Contribute to the development and implementation of clinical operations strategies.
- Maintain accurate and up-to-date study documentation and databases.
- Facilitate and support internal and external audits and inspections.
- Prepare and present study progress reports to project management and key stakeholders.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Master's degree preferred.
- Minimum of 7 years of progressive experience in clinical research, with at least 2 years in a Lead CRA or senior CRA role.
- Extensive knowledge of ICH-GCP guidelines and regulatory requirements (FDA, EMA, etc.).
- Proven experience in managing and monitoring clinical trials across various phases (II-IV).
- Demonstrated leadership and team management skills.
- Excellent written and verbal communication skills.
- Strong organizational and time management abilities.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently and as part of a global, remote team.
- Willingness to travel occasionally for essential study-related activities (if required, though the role is predominantly remote).
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Lead Clinical Research Associate
Posted 8 days ago
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Job Description
Our client is recruiting a dynamic and experienced Lead Clinical Research Associate for a fully remote position. This role is essential for overseeing and managing clinical trial operations, ensuring compliance with regulatory standards and company protocols. The Lead CRA will be responsible for site selection, initiation, monitoring, and closure of clinical trial sites, conducting remote monitoring visits and ensuring data integrity. You will serve as the primary point of contact for investigators and site staff, providing guidance and support to ensure accurate and timely completion of trial-related activities. This includes developing and implementing site management plans, training site personnel, and resolving any issues that may arise during the trial. The successful candidate will also be involved in protocol development, CRF design, and the development of study-related documents. Excellent communication and interpersonal skills are vital for building strong relationships with investigative sites and internal teams. The Lead Clinical Research Associate will be expected to travel occasionally for essential site visits or team meetings, but the primary mode of operation is remote. This position requires a thorough understanding of ICH-GCP guidelines and other relevant regulatory requirements. The ability to manage multiple studies, prioritize tasks effectively, and work autonomously in a remote setting is critical. This is an excellent opportunity for a seasoned CRA to take on leadership responsibilities and contribute to the successful execution of critical clinical research projects.
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3
Lead Clinical Research Associate
Posted 5 days ago
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Job Description
Our client is a leading innovator in the pharmaceutical sector and is searching for a highly experienced Lead Clinical Research Associate (CRA) to join their dynamic, remote-first team. This pivotal role involves overseeing and managing clinical trial activities, ensuring compliance with regulatory standards, and contributing to the successful development of life-saving medications. The successful candidate will be responsible for the end-to-end management of clinical studies, from site selection and initiation to monitoring, close-out, and data integrity verification. You will provide guidance and mentorship to a team of CRAs, fostering a collaborative and high-performance environment. A deep understanding of Good Clinical Practice (GCP) guidelines, ICH regulations, and relevant local regulatory requirements is essential. Key responsibilities include developing clinical trial protocols, preparing regulatory submissions, managing investigator sites, and ensuring the safety and well-being of study participants. You will also be involved in data analysis, report generation, and contributing to the overall strategy for clinical development programs. This position requires exceptional organizational skills, meticulous attention to detail, and the ability to manage multiple projects simultaneously. Strong leadership capabilities and excellent communication skills, both written and verbal, are crucial for effective interaction with internal teams, investigators, and regulatory bodies. The ideal candidate will have a proven track record in managing complex clinical trials, a solid understanding of pharmaceutical drug development, and a passion for advancing medical science. This is a fully remote role, requiring a self-disciplined individual who can work autonomously and effectively manage their time. You will be expected to travel occasionally to sites for essential monitoring activities as per regulatory requirements and project needs, though the primary mode of work is remote.
Responsibilities:
Responsibilities:
- Lead and manage clinical trial activities from initiation to close-out.
- Ensure compliance with GCP, ICH guidelines, and all relevant regulations.
- Develop and implement clinical trial protocols and study plans.
- Select, train, and oversee investigator sites and clinical research staff.
- Monitor study conduct, data quality, and participant safety.
- Manage study budgets and timelines effectively.
- Prepare regulatory submissions and interact with health authorities.
- Analyze clinical data and contribute to study reports.
- Mentor and guide junior CRAs and research personnel.
- Collaborate with cross-functional teams, including R&D, regulatory affairs, and biostatistics.
- Bachelor's degree in a life science, nursing, or related field. Advanced degree (Master's or PhD) preferred.
- Minimum of 8 years of experience in clinical research, with at least 3 years in a lead or supervisory role.
- Extensive knowledge of GCP, ICH, and regulatory requirements for clinical trials.
- Proven experience in managing multiple clinical trials simultaneously.
- Strong understanding of pharmaceutical drug development processes.
- Excellent leadership, communication, and interpersonal skills.
- Proficiency in clinical trial management software and EDC systems.
- Ability to travel for site visits as required (up to 30%).
- Demonstrated ability to work independently and effectively in a remote setting.
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4
Lead Clinical Research Associate
Posted 4 days ago
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Job Description
Our client, a renowned global pharmaceutical company, is actively recruiting for a Lead Clinical Research Associate (CRA) to contribute to groundbreaking medical advancements. This is a fully remote position, offering the flexibility to work from anywhere while driving critical research initiatives. As a Lead CRA, you will be responsible for overseeing and managing clinical trials, ensuring compliance with all regulatory requirements, ethical guidelines, and study protocols. You will lead a team of CRAs, providing guidance, mentorship, and support to ensure the successful execution of studies. Key responsibilities include site selection and initiation, monitoring trial progress, data collection, and ensuring data integrity. You will serve as the primary point of contact for investigative sites, resolving issues promptly and effectively. This role requires a deep understanding of clinical trial phases, Good Clinical Practice (GCP) guidelines, and relevant pharmaceutical regulations. The ability to foster strong relationships with investigators, site staff, and internal stakeholders is essential. As a remote leader, you must excel in virtual communication, project management, and team motivation. You will leverage technology to track study progress, manage documentation, and facilitate collaboration across dispersed teams. The ideal candidate holds a Bachelor's degree in a life science, nursing, or a related field, with a minimum of 7 years of experience in clinical research, including at least 2 years in a leadership or supervisory role. Experience with various therapeutic areas is a plus. Strong knowledge of electronic data capture (EDC) systems and clinical trial management systems (CTMS) is required. Excellent organizational, problem-solving, and interpersonal skills are necessary. This remote role, conceptually linked to Ruiru, Kiambu, KE , offers a unique opportunity to shape the future of healthcare through diligent and strategic research management.
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