Job
Description
As a CRA II/Sr CRA II based in Mumbai, you will be a part of Syneos Health, a leading biopharmaceutical solutions organization committed to accelerating customer success. Our focus is on translating clinical, medical, and commercial insights into outcomes that address current market realities. At Syneos Health, the patient and customer are at the core of our Clinical Development model. We are dedicated to simplifying and streamlining our work processes to ensure a seamless experience for both our employees and customers. Key Responsibilities: - Possess a minimum of 4 years of onsite monitoring experience - Demonstrate expertise in the oncology therapeutic area - Preferably based in Mumbai for client-based opportunities - Conduct on-site and remote monitoring of clinical research studies to ensure compliance with best clinical practices - Develop tools, procedures, and processes to ensure quality monitoring, including creating monitoring plans and checklists - Contribute to the design and implementation of processes, programs, and policies, such as SOPs and training materials - Manage specific project components, coordinate site visits, track study progress, and resolve issues - Ensure accurate documentation of monitoring activities, findings, and reports - Collaborate with cross-functional teams to support clinical trial operations and ensure smooth study conduct Qualifications: - Bachelor's degree in a related field or equivalent experience - 2-4 years of experience in clinical research monitoring - Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements - Excellent communication and interpersonal skills - Ability to work independently, manage multiple priorities, and use clinical trial management systems and relevant software effectively Certifications: - Certified Clinical Research Associate (CCRA) or equivalent certification preferred Necessary Skills: - Attention to detail and strong analytical skills - Problem-solving abilities and critical thinking - Effective teamwork, organizational, and time management skills - Proficiency in Microsoft Office Suite In addition to the above responsibilities and qualifications, you will be part of a global team that has collaborated on a significant number of FDA-approved drugs and EMA-authorized products in the past five years. Syneos Health values diversity and inclusivity, creating a workplace where everyone feels they belong and can contribute to the company's success. Please note that the tasks, duties, and responsibilities listed in this job description are not exhaustive. The Company may assign additional tasks at its discretion. The Company is committed to compliance with all relevant legislation and regulations, including providing reasonable accommodations for employees or applicants as needed. Your role as a CRA II/Sr CRA II at Syneos Health will have a significant impact on ensuring the quality and integrity of clinical research studies. By adhering to clinical practices and protocols, you will contribute to the reliability and validity of study results, ultimately advancing medical knowledge and improving patient outcomes.,
