CRA II (Sponsor dedicated) Athens Homebase Syneos Health

2.0 - 6.0 years

0 Lacs

rajasthan

On-site

As a Clinical Research Associate II (Sponsor dedicated) in Athens Homebase at Syneos Health, you will play a crucial role in ensuring site compliance with regulatory guidelines and protocol requirements. Your responsibilities will include performing site qualification, initiation, monitoring, management activities, and close-out visits either on-site or remotely. You will assess site performance, provide recommendations, and escalate any serious issues to the project team promptly. Your attention to detail will be essential as you verify the informed consent process, assess factors affecting subject safety, and review clinical data for accuracy and completeness. You will conduct source document reviews, resolve queries, and ensure site compliance with electronic data capture requirements. Additionally, you may be involved in investigational product inventory, reconciliation, and storage reviews. Maintaining accurate documentation, such as confirmation letters, follow-up letters, and trip reports, will be part of your routine tasks. You will support subject recruitment and retention strategies, enter data into tracking systems, and manage site-level activities to meet project objectives within specified timelines. Your adaptability to changing priorities and ability to communicate effectively with study site personnel will be crucial for success in this role. As a Clinical Research Associate II, you will also participate in Investigator Meetings, sponsor meetings, and clinical training sessions. You will work towards audit readiness standards, prepare for audits, and ensure compliance with applicable regulatory requirements. Your knowledge of Good Clinical Practice guidelines and relevant regulations will guide your actions throughout the study lifecycle. To excel in this role, you should hold a Bachelor's degree or RN in a related field, have knowledge of ICH Guidelines and regulatory requirements, possess strong computer skills, and be willing to travel up to 75% of the time. Excellent communication skills, the ability to work collaboratively, and a commitment to maintaining high standards of quality and compliance are essential for success in this position. Join us at Syneos Health, where you will have the opportunity to make a meaningful impact on the lives of patients and contribute to the advancement of healthcare through innovative clinical research practices. Discover a rewarding career with a global organization that values diversity, inclusivity, and professional growth. Visit our website to learn more about Syneos Health and the exciting opportunities we offer.,

Posted 3 days ago

Apply

Clinical Research Associate I IQVIA India

1.0 - 5.0 years

0 Lacs

delhi

On-site

As a Clinical Research Associate -I, your role will involve performing monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations, guidelines, and sponsor requirements. Your essential functions will include conducting site monitoring visits, working with sites to drive subject recruitment plans, administering protocol and study training to sites, and evaluating the quality and integrity of study site practices. You will also be responsible for managing the progress of assigned studies, maintaining documentation regarding site management, collaborating with study team members, and supporting the development of project subject recruitment plans. To qualify for this position, you must have a degree in BPharm, MPharm, BDS, BAMS, or BHMS. Additionally, you should have at least 1-2 years of on-site monitoring experience and a good knowledge of applicable clinical research regulatory requirements such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Furthermore, you should possess good therapeutic and protocol knowledge, computer skills including proficiency in Microsoft Word, Excel, and PowerPoint, as well as written and verbal communication skills. Organizational, problem-solving, time management, and financial management skills are also important for this role. Lastly, you should be able to establish and maintain effective working relationships with coworkers, managers, and clients.,

Posted 1 month ago

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.