The CRA II is a seasoned, experienced professional in monitoring and site management. Responsibilities will be dependent upon the type and timing of the program to which the CRA II is assigned and typically include activities involving start-up and study implementation, on-site monitoring of clinical research studies as well as on-going site management. Incumbents work independently as a study team member.

Coordinates all aspects of the clinical site monitoring services, assessing for protocol and regulatory compliance. Responsibilities include driving investigative site and patient recruitment, conducting source data verification, assessing drug accountability, data collection, (regulatory) document collection, performing qualification, initiation, monitoring and close out visits at investigational sites in accordance with corporate, sponsor and regulatory standards.

The Registered Dietician (RD) position delivers strong customer experience for both sites and patients by providing remote study support under the delegation of a PI. The RD is responsible for assessing nutritional needs, promoting healthy physical activity, and providing personalized Lifestyle Counseling to optimize nutritional status during pharmacotherapy.

Play a crucial role in the set-up and execution of groundbreaking studies. This position will work together with the Sr. Director, Clinical Operations on the study start-up and infrastructure items from the initial phases of study set-up to hands-on clinical monitoring and site management.

Primarily a training and development role, this position supports and observes clinical site monitoring services both inhouse and in the field whilst developing CRA skills and knowledge. This role has exposure and training in all aspects of the clinical site monitoring services while providing monitoring and site management activities for full-service studies, assessing protocol, SOP, and regulatory compliance.

The Manager, Central Study Coordinators hires, develops, enables, and engages their team of Central Study Coordinators (CSCs) to ensure a high level of performance and an exceptional customer experience. The manager will provide day to day support to the CSCs to drive study results and help CSCs navigate the complexities of study operations. Responsibilities include collaborating with sponsor teams, Care Access leadership, and other teams as required to deliver study results.

Johnson & Johnson is hiring for a Field Clinical Specialist for Shockwave Medical Inc. The Field Clinical Specialist will provide case support to physicians within certain territories on peripheral and coronary interventional procedures in the pre-market and post-market phases of product development with the Shockwave Medical Intravascular Lithotripsy (IVL) ® technology. The Field Clinical Specialist will also play a critical role in clinical studies.

The Clinical Coder primarily oversees the coding process for applicable clinical trials. Works with the Safety and Data Management teams to review and code terms per the procedures set forth by RQM+ and sponsors. Facilitates review and coding activities to allow other functional processes to proceed smoothly.

This contract position ensures that data collected for clinical studies is accurate, plausible, and traceable to source documentation, assisting in site management, and clinical study materials development.

Oversee multiple oncology trials, ensuring high-quality execution. Provide leadership and mentorship to junior flex team members. Act as Lead SM, training and guiding other Site Managers on study protocols. Develop essential study start-up documents, including SIV agendas. Represent Site Managers and Lead Trial Managers (LTMs) in key meetings.