Clinical Trial Associate

SUMMARY:

Clinical Trial Associate (CTA) will support the planning, implementation, and management of clinical trials. Working closely with cross-functional teams, the Clinical Trial Associate oversees various aspects of clinical trial activities, delivering timely and quality results while adhering to study protocols and complying with regulatory requirements. The Clinical Trial Associate is a key member who contributes to the development and maintenance of trial documentation, processes, and ensures smooth trial operations. This is an exciting opportunity to be at the forefront of our mission and make a significant impact on the growth and direction of the Company.

RESPONSIBILITIES:

·      Assist in the identification of clinical research sites.

·      Liaise with investigational sites to ensure proper site initiation, and ongoing support.

·      Assist in collection of regulatory documents from various clinical research sites during the study start up process and submitting them to the Central IRB.

·      Organize and send out study start up packages to sites and track incoming documents.

·      Process invoices and follows up with the clinical teams promptly for review and approval.

·      Assist with sunshine act tracking by submitting invoices to a Vendor.

·      Organize the set up and maintenance of trial master file.

·      Create and assemble investigator site file binders / pharmacy binders.

·      Draft and finalize meeting minutes for assigned study team meetings.

·      Support CRAs with study visits as necessary ensuring essential documents are up to date.

·      Order supplies and ship them to sites as necessary (Lab Kits, etc.)

·        Communicate regularly with study sites for trial support.

·      Conduct an audit of the Trial Master files (Site and Central)

·      Work with vendors and support execution of contracts, ensuring adherence to internal contract process.

·      Foster effective communication within cross-functional teams, including clinical operations, regulatory affairs, data management, and medical affairs.

·      Track and document SOP completion for external consultants

·      Successfully deliver on other related projects as assigned.

QUALIFICATIONS:

·      Bachelor’s degree in a relevant scientific or healthcare field.

·      2 years’ experience in clinical operations as a Clinical Trial Associate

·      Pharmaceutical or CRO experience in /immunology or hematology is preferred.

·      In-depth understanding of GCP, regulatory requirements, and clinical trial processes.

·      Proficient in using relevant clinical trial management software and tools, including eTMF.

·      Strong organizational, communication, and problem-solving skills.