2 Lead Clinical Research Associate Cra jobs in whatjobs
Lead Clinical Research Associate (CRA)
Posted 22 days ago
Job Viewed
Job Description
Our client, a pioneering pharmaceutical firm, is actively searching for an experienced and dedicated Lead Clinical Research Associate (CRA) to join their expanding research team. This is a fully remote position, enabling you to contribute to groundbreaking drug development from the comfort of your home. As a Lead CRA, you will play a pivotal role in overseeing and managing clinical trial activities, ensuring compliance with regulatory standards, and driving the successful execution of studies. Your responsibilities will include coordinating and monitoring clinical trial sites, performing site visits (pre-study, initiation, routine monitoring, and close-out), ensuring data integrity and accuracy, and verifying adherence to protocols and Good Clinical Practice (GCP) guidelines. You will also be responsible for mentoring and training junior CRAs, serving as a key point of contact for investigators and site staff, and resolving site-level issues promptly. This role demands a deep understanding of pharmaceutical research, regulatory affairs, and clinical trial management. The ideal candidate will possess exceptional organizational, communication, and interpersonal skills, with a proven ability to manage multiple tasks and priorities effectively. Experience in therapeutic areas such as oncology, cardiology, or infectious diseases is highly valued. A strong track record of successful site management and a commitment to quality and patient safety are essential. You will work collaboratively with internal teams, including data management, biostatistics, and regulatory affairs, to ensure seamless trial progression. This remote role requires self-discipline, proactivity, and a results-driven approach. A Bachelor's degree in life sciences, nursing, or a related field is mandatory. Advanced degrees or relevant certifications (e.g., ACRP, SoCRA) are a plus. This is an exceptional opportunity to advance your career in clinical research within a supportive and innovative environment. Be part of a team that is committed to improving global health through cutting-edge pharmaceutical development. Your expertise will directly contribute to bringing life-changing therapies to patients worldwide. Embrace a flexible work model that prioritizes outcomes and professional growth.
This advertiser has chosen not to accept applicants from your region.
0
Lead Clinical Research Associate (CRA)
Posted 8 days ago
Job Viewed
Job Description
Our client is seeking a highly motivated and experienced Lead Clinical Research Associate (CRA) to oversee and manage clinical trials remotely. This is a fully remote position, demanding exceptional organizational skills and a deep understanding of pharmaceutical research protocols. As a Lead CRA, you will be responsible for the initiation, monitoring, and closure of clinical trial sites, ensuring compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and study protocols. You will conduct site visits (remote and, as needed, on-site), review source documentation, verify data accuracy, and ensure the safety and rights of study participants. Your role will involve training and mentoring junior CRAs, acting as the primary point of contact for investigators and study staff, and escalating any issues or risks to the project management team. The ideal candidate will possess a strong background in clinical trial management, a keen eye for detail, and the ability to make critical decisions independently. You will be adept at problem-solving and proactive in identifying and mitigating potential risks to trial timelines and data integrity. Given the fully remote nature of this role, superior communication and interpersonal skills are essential. You must be able to build strong relationships with site personnel and internal stakeholders through virtual channels. We are looking for a self-starter who is results-oriented, highly disciplined, and capable of managing their workload effectively without direct supervision. Your expertise will be crucial in ensuring the successful execution of complex pharmaceutical studies. The ability to navigate challenging situations with professionalism and efficiency is key. You will also contribute to the development of study-related documents and participate in internal audits and regulatory inspections. This is an excellent opportunity to take on a leadership role within a growing pharmaceutical research organization and make a significant impact on drug development. You will be a key player in ensuring the quality and integrity of the data collected, which is vital for bringing life-saving treatments to market. Your contributions will directly influence the advancement of medical science.
Key Responsibilities:
Key Responsibilities:
- Lead and manage multiple clinical trials and associated CRAs.
- Ensure compliance with GCP, ICH guidelines, and all applicable regulatory requirements.
- Initiate, monitor, and close-out clinical investigator sites.
- Conduct pre-study, initiation, interim, and close-out monitoring visits (remotely and potentially on-site).
- Verify the accuracy and completeness of source documentation and case report forms (CRFs).
- Ensure proper conduct of the study according to the protocol, including patient eligibility, drug accountability, and adverse event reporting.
- Train and mentor site staff and junior CRAs on study procedures and protocols.
- Serve as the primary liaison between the sponsor, study sites, and regulatory authorities.
- Identify, document, and escalate site issues and risks to the clinical operations team.
- Develop and maintain strong working relationships with investigators, study coordinators, and other site personnel.
- Review monitoring reports and ensure timely resolution of identified issues.
- Participate in the development of study-related documents, such as protocols, informed consent forms, and monitoring plans.
- Contribute to internal audits and support regulatory inspections.
- Bachelor's degree in a life science, nursing, or related field. Advanced degree preferred.
- Minimum of 5-7 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical industry.
- Demonstrated experience in a Lead CRA or similar supervisory role.
- Thorough understanding of ICH-GCP guidelines and regulatory requirements.
- Experience with various therapeutic areas.
- Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Excellent written and verbal communication skills, with the ability to build rapport remotely.
- Strong organizational, problem-solving, and critical-thinking skills.
- Ability to work independently, manage time effectively, and prioritize tasks in a remote setting.
- Willingness to travel as required for on-site monitoring or training.
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Lead clinical research associate cra Jobs in Kenya !
1