Clinical Trial Associate

This is a fully remote position, open to applicants in Michigan.

📋 Description

• Deliver extensive administrative assistance for clinical trial operations, which includes organizing, maintaining, and updating study documentation within the Trial Master File (TMF).

• Oversee documentation processes to ensure compliance with regulatory requirements and Good Clinical Practice (GCP) standards.

• Aid in the preparation, review, and submission of Institutional Review Board (IRB) documents.

• Monitor compliance with study protocols and regulatory guidelines, identifying and resolving any compliance issues.

• Support daily trial operations and work collaboratively with cross-functional teams to address operational challenges.

• Track and manage study data, including Case Report Forms (CRFs), ensuring data accuracy and prompt system entry.

• Oversee trial progress and performance metrics, maintain communication with study sites, draft status reports, and escalate issues as necessary.

• Coordinate communications with sites and act as a primary contact for inquiries and updates.

• Undertake additional responsibilities assigned by the Associate Director of Clinical Affairs.

⛳️ Requirements

• Bachelor's degree or an equivalent combination of experience, education, and training.

• A minimum of 2 years of experience at the Sponsor or CRO level, or 5 years at the SMO or site level.

• Preferred experience with medical device clinical studies.

• Familiarity with shoulder arthroplasty or orthopedics is beneficial but not mandatory.

• Understanding of clinical development standards and regulatory requirements (GCP, FDA).

• Knowledge of current industry standards (e.g., GCP, ICH, CDISC/CDASH).

• Proficient in Microsoft Office (Excel, Word) with strong Excel skills required.

• Experience working within cross-functional, multi-site clinical trial teams.

🏝️ Benefits

• Positive company culture.

• Opportunities for professional advancement.

• Competitive salary.

• Benefits package.