Clinical Trial Coordinator

Benefits

Qualifications

• •Exceptional organizational skills and attention to detail; ability to prioritize multiple tasks effectively
• •Strong written and verbal communication skills, with a professional demeanor in cross-functional settings
• •Adept at learning new systems and technologies, including eTMF and CTMS platforms
• •Proficient in standard office software, such as Microsoft Office Suite
• •Demonstrated capability to work independently as well as a team player in a dynamic environment
• •Critical thinking and problem-solving skills are essential
• •Ability to uphold confidentiality and adhere to high ethical standards
• •Proficient computer skills, particularly in Microsoft Office applications
• •Able to thrive in a fast-paced environment while efficiently managing competing priorities
• •Excellent interpersonal skills are necessary for effective collaboration with diverse teams
• •Strong writing skills to assist in creating communications and documentation as needed
• •8 more items(s)

Responsibilities

• •As a Clinical Trial Coordinator (CTA), you will play a pivotal role in supporting the execution of clinical trials, handling critical administrative tasks to ensure all study deliverables are met with the highest data quality
• •You will proactively identify and resolve operational issues, and contribute to continuous improvement initiatives while adhering to established Clinical Standard Operating Procedures and ICH Good Clinical Practice Guidelines
• •Provide comprehensive administrative support to the clinical trial team, including document development, formatting, and study-specific information review
• •Maintain weekly updates on study statuses, including IRB approvals and patient enrollment
• •Utilize databases and spreadsheets to track and prepare study-related information
• •Review and approve essential study documentation, such as informed consent forms and study plans
• •Manage clinical supplies and assist with the logistics of site binders
• •Coordinate meetings, ensuring effective communication by taking and distributing minutes
• •Support training initiatives for vendors and clinical site personnel
• •Oversee the movement of laboratory samples and track laboratory data efficiently
• •Work independently and collaboratively while managing deadlines and demonstrating problem-solving abilities
• •Familiarity with Trial Master Files (TMF) and electronic TMF systems (e.g., Veeva) is essential
• •Assist the Clinical Regulatory Operations Specialist with maintaining the quality and completeness of TMF documentation
• •Perform additional tasks as assigned to support the team
• •This role is primarily remote but may require occasional travel for on-site meetings
• •12 more items(s)