The OpportunityThe 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.
- Study and Activity Monitoring:
- 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.
- Provide Support to CTM:
- 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.
- Proactive lines of communication:
- 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.
- Project Documentation and Deliverables:
- 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.
Who You Are:(Required)- 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.
Preferred:- 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.
This position is based in Boston or Remote
Relocation benefits are not available for this position.
The expected salary range for this position based on the primary location Boston, MA is $63,750 - $97,750. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
