Clinical Trial Associate

PathAI•Boston, MA

12h•$63,750 - $97,750•Remote

About The Position

PathAI's mission is to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life-saving therapies to patients more quickly. At PathAI, you'll work with a diverse and talented team of people, who are dedicated to solving complex problems and making a huge impact. The Clinical Trial Associate (CTA), Clinical Development Services will play a vital role in the Clinical Operations team. Through responsibilities like monitoring of clinical trial lab services, engaging with clinical investigator sites and supporting the primary CTM, this role will ensure successful completion of clinical studies with a lab services component.

Requirements

3+ years of clinical research experience in medical device and/or drug development clinical trials
BS or BA in a relevant scientific discipline
Good organizational skills, attention to details, and ability to multitask
Strong understanding of GCP, ICH, and knowledge of regulatory requirements in support of successful clinical trials.
Adherence to the Code of Federal Regulations (Title 21) and guidelines set up by the International Committee for Harmonization (ICH) for good clinical practices.

Nice To Haves

Experience in digital pathology, radiology or other imaging technology-based clinical trials is highly preferred.
Project Management Certification is a plus.

Responsibilities

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.
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.
Perform other administrative or process-related duties as needed to support the success of the trial.