Clinical Trial Administrator - Wound Care - CEDENT

We are looking for an experienced Clinical Trials Administrator to oversee and manage a multi-site wound care clinical trial across the Boston and New England area. This is a 1-year contract role, with the possibility of extension based on performance. The role requires extensive experience in clinical trials, particularly in wound care, and involves building infrastructure and directly handling all operational aspects of the trial.
 

• Lead the setup, execution, and daily management of the wound care clinical trial, overseeing patient recruitment, data collection, regulatory compliance, and reporting.

• Establish and manage data management, patient tracking, and reporting infrastructure; oversee eTMF maintenance and final data lock for complete and accurate documentation.

• Act as the primary liaison for clinical sites, conducting in-person visits for site setup, monitoring, and close-out, and ensuring compliance with protocols; coordinate with external vendors.

• Develop and deliver training programs for site staff on trial protocols and wound care patient standards.

• Ensure all trial activities meet regulatory requirements, including IRB submissions, and maintain thorough documentation, including adverse event monitoring and reporting.

• Gather, organize, and analyze trial data, presenting updates to stakeholders; proactively address potential risks with contingency plans.

• Develop patient engagement and retention initiatives, including education materials and support programs focused on wound care.

• Conduct regular audits at clinical sites to ensure adherence to protocols and regulatory standards.

• Travel daily to clinical sites within the Boston and New England region, coordinating visit logistics and maintaining strong communication with site personnel.
   

• At least 5 years of direct experience in clinical trials, with a strong emphasis on wound care.

• Competence with project management tools for tracking trial progress and managing critical tasks.

• Proven ability in site auditing, data compliance, and building clinical trial infrastructure.

• Solid knowledge of wound care guidelines, chronic wound management, and patient-centered trial designs.

• Excellent organizational and communication skills; proficient in data management tools and eTMF systems.

• Bachelor’s degree in Life Sciences, Nursing, Clinical Research, or related field; advanced degree or clinical research certification (e.g., CCRC, CCRP) preferred.

• Ability to travel daily across the Boston and New England area.