Our Clinical Affairs department specializes in pre and post-market, observational, device and biologic studies. The CRA I will report to the Manager of Clinical Affairs and will be responsible for monitoring the progress of clinical studies at clinical sites, and ensuring that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
The CRA I will assist clinical affairs in creating, reviewing and preparing documents, maintaining the Trial Master File for each study and preparing any documentation needed for regulatory filings and/or IRB submissions. S/he will have a proven ability to independently prioritize and manage multiple tasks and projects with competing priorities and deadlines, screen and prioritize communications and opportunities from external sources. The ideal candidate will be dynamic, articulate, high-energy, organized, and able to support cross-functional coordination in a fast paced environment.
Approximately 20-30% travel, US sites; CRA will be based in-house at Organogenesis when not traveling.
The usual duties of the Clinical Research Associate include but are not limited to the following:
- Assists in study start-up activities (i.e. preparation of protocols, CRFs, ICF document, Regulatory Binders, etc. using existing templates; clinical site recruitment/selection
- Assists Study Team across all clinical sites and ensures compliance with protocol and overall clinical objectives by coordinating and tracking activities for clinical trials in compliance with protocol, Standard Operating Procedures (SOPs) and regulatory guidelines from the inception of the protocol through database lock process.
- Assists in tracking the day-to-day progress of clinical site activities and updating the appropriate clinical tracking systems at regular intervals.
- Ensures that study activities are executed according to the study protocol, regulatory guidelines, SOPs, Good Clinical Practice (GCP) and ICH guidelines.
- Monitor/co-monitor clinical study sites, as needed, or in coordination with CROs for Organogenesis sponsored studies.
- Perform in-house site management functions for ongoing clinical trials at Organogenesis in accordance with GCP guidelines, FDA or other applicable regulatory agency regulations and internal SOPs
- May draft materials including protocols, informed consent documents, training documents, and SOPs
- Responsible for assisting with review and collection of clinical data and regulatory documents at designated study sites; act as primary site contact; works closely with study team to manage and execute clinical studies and fulfill program goals and timelines
- Maintains effective communication via written, oral and /or electronic contacts.
- Completes all clinical, corporate, and project specific training and attends meetings as required.
- Previous experience of 1-3 years in Clinical Research, Clinical Affairs or Clinical Operations preferred.
- Bachelor’s degree in a life science
- Medical device experience a plus.
- Knowledge of FDA, ICH, GCP and local regulations/guidelines
- Proven ability to multi-task and work collaboratively as well as independently
- Strong communication skills (written and oral)
- Detail oriented
- Knowledge of clinical trial process