[Remote] Clinical Trial Associate

Note: The job is a remote job and is open to candidates in USA. PathAI is hiring a Clinical Trial Associate for its Clinical Operations team. The role supports clinical studies with laboratory services through study monitoring, investigator-site and vendor coordination, CTM support, and project documentation.

Responsibilities

• Bring a strong understanding of GCP, ICH, and knowledge of regulatory requirements in support of successful clinical trials
• Adhere to the Code of Federal Regulations (Title 21) and guidelines set up by the International Committee for Harmonization (ICH) for good clinical practices
• Oversee and manage the timely closure of queries issued to clinical trial investigator sites and/or other designated parties
• Work with the CTM to proactively identify trends and provide feedback to internal departments and/or clients on performance of both the Investigator and the PathAI BioPharma Laboratory to ensure timely service delivery. Examples may include:
• Monitor the performance of both the Investigator(s) and/or the Laboratory as applicable
• Monitor study specific and/or Sponsor requested requirements
• Oversee and/or monitor queries, pending results, testing TATs, etc
• Collaborate with data management to ensure resolution of data discrepancies at all stages of the study
• Assist with the organization and tracking of storage specimens: receipt, retrieval, and shipping as applicable
• Coordinate with external vendors and Sponsors to ensure delivery of laboratory kits and test results to sites
• Perform generic, routine study duties and tasks that are applicable across assigned clinical trials, including but not limited to: receipt of site lists, drafting of site facing laboratory manuals, managing laboratory kits orders, and monitoring the day-to-day trial operations (i.e., specimen management reports, case assignments on the PathAI AISight CT Platform, monitoring pending lab analysis, etc.)
• Support the CTM for routine administrative tasks of the clinical trial (e.g., action item tracking, meeting minutes, process mapping, etc.)
• Act as a backup support for the CTM during their times of absence, including leading client communication and study management activities
• Interact with other functional areas and/or vendors to resolve problems, enhance processes, and service delivery
• Liaise with other departments and support services (e.g., Laboratory, Engineering, etc) to expedite testing of patient’s laboratory specimens and/or provision of kits
• Coordinate information and communications for designated projects at the site level, including identification and escalation of discrepancies as needed
• Assist with the development of meeting or training materials where applicable
• Assist in reviewing study start up project deliverable schedule, milestones and required tasks
• Support maintenance of project documentation files
• Oversee and/or lead Project Close-out procedures as required
• Assist with the development of meeting or training materials where applicable
• Perform other administrative or process-related duties as needed to support the success of the trial

Skills

• You have 3+ years of clinical research experience in medical device and/or drug development clinical trials and a BS or BA in a relevant scientific discipline
• You have good organizational skills, attention to details, and ability to multitask
• You have experience in digital pathology, radiology or other imaging technology-based clinical trials is highly preferred
• You have Project Management Certification is a plus

Benefits

• This position is based in Boston or Remote

Company Overview

Company H1B Sponsorship