Sr. CRA (Clinical Research Associate)

About the Role

We are seeking a highly motivated and experienced Senior Clinical Research Associate (CRA) to oversee and manage critical aspects of clinical research studies, spanning Phase I through Phase IV, as well as Real World Evidence (RWE) studies. In this pivotal role, you will play a key part in the drug development process while ensuring strict adherence to International Council for Harmonisation (ICH) / Good Clinical Practice (GCP) guidelines, regulatory requirements, and internal Standard Operating Procedures (SOPs). The ideal candidate will demonstrate a deep understanding of clinical trial operations, strong leadership capabilities, and a commitment to maintaining the highest standards of ethical and regulatory compliance.

Key Responsibilities

The Senior CRA will serve as the primary point of contact for assigned study sites, providing guidance, oversight, and support to ensure seamless execution of clinical trials. Your responsibilities will include:

• Site Management and Monitoring: Conduct comprehensive site visits, including pre-study visits (PSV), site initiation visits (SIV), interim monitoring visits (IMV), and close-out visits (COV), ensuring all activities are completed with precision, quality, and adherence to timelines as outlined in the Monitoring Plan. Maintain compliance with all applicable regulatory requirements, SOPs, and ICH GCP guidelines.
• Study Start-Up and Feasibility: Assist with or oversee critical study start-up activities, including feasibility assessments, pre-study evaluations, and site selection processes to identify and engage high-performing investigative sites.
• Documentation and Compliance: Collect, review, and meticulously track essential regulatory and study documents, ensuring completeness and accuracy. Participate in investigator, client, and project team meetings, including delivering presentations when required.
• Subject Enrollment and Investigational Product (IP) Management: Develop and implement effective subject enrollment strategies for assigned study sites. Ensure proper storage, dispensation, and accountability of all Investigational Products and trial-related materials in accordance with study protocols and regulatory standards.
• Data and System Utilization: Utilize advanced systems and reporting tools to monitor subject status, case report form (CRF) retrieval, source document verification (SDV), regulatory documentation, and IP tracking. Conduct remote monitoring activities as specified in the study-specific Monitoring Plan.
• Project Team Collaboration: Actively participate as a valued member of the Project Team, contributing to the development of CRFs and other study-related documents, such as Monitoring Plans and subject worksheets. Customize and review patient information sheets, informed consent forms, protocol synopses, and other study documents in alignment with required procedures.
• Site Payments and Contracts: Where applicable, support or oversee contract negotiations with study sites, manage investigator payments, and ensure accurate tracking of site payments to maintain financial transparency and compliance.
• Mentorship and Training: Serve as a mentor and trainer for junior CRAs, providing guidance, conducting training sessions, and performing assessment visits to foster professional growth and development within the team.
• Regulatory Affairs Support: Provide support to the Regulatory Affairs Study Start-up Team by preparing or revising documentation for submissions to Ethics Committees, Regulatory Authorities, and Competent Authorities. Follow up on the evaluation process until approvals are secured and provide regular updates to the Sponsor/Client.
• Leadership and Oversight: Function in the role of Lead CRA for assigned projects, taking ownership of site management activities, identifying potential site issues, and implementing corrective and preventive actions or escalating concerns as necessary. Collaborate closely with Clinical Data Management to facilitate data cleaning activities and ensure the integrity of study data.

Qualifications and Experience

To excel in this role, candidates must possess a Bachelor’s degree in a scientific or health-related field, along with a minimum of 5+ years of experience as a Clinical Research Associate. Strong knowledge of ICH/GCP guidelines, regulatory requirements, and clinical trial operations is essential. Excellent communication, organizational, and problem-solving skills are critical, as is the ability to work independently and collaboratively within a dynamic team environment. Proficiency in using clinical trial management systems and tools is a plus. The ideal candidate will demonstrate a proactive approach to issue resolution, a keen attention to detail, and a commitment to upholding the highest ethical and professional standards in clinical research.