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