Clinical Research Associate

Consultant, Clinical Project Specialist, Medical Devices

Summary

Our client, a Fortune 500 Medical Device Company
, has engaged GForce Life Sciences to provide an entry level Clinical Project Specialist role in the Study Operations Project Management team. This role participates in the execution of clinical device studies, ensures compliance to study protocol, domestic and international Good Clinical Practices, and applicable regulatory standards. This role’s dedicated focus is on study management support activities which may include vendor oversight.

• Manage all aspects of the subject selection committee work
• Tracking and results-oriented communication of data entry needs/ timelines to sites, core labs, and colleagues
• Leveraging knowledge of specific protocol and committee charter requirements (i.e. inclusion/exclusion criteria and procedural requirements) with ability to resolve discrepancies prior to committee review
• Facilitate timely committee member adjudications via offline email review and/or live teleconference review calls between committee members, site investigators, and internal stakeholders
• Work with site and core lab to process images and if applicable to help sites to prepare slides for review meetings
• Frequently communicate review status, including final adjudication results, to site investigators and research staff, and field clinical personnel
• Track committee member consulting time to facilitate consultant billing
• Ensure good documentation practices by timely database documentation of committee decisions, archival of supporting documentation, as well as, note to file generation when needed
• Collaborate with clinical study and field teams to track all prospective committee cases
• Provide feedback for applicable study protocol sections, training plans, and presentations, as well as contributing to committee charter creation and subsequent revisions
• Manage trial timelines and deliverables for annual database locks with the study team and sites

• Bachelor's degree. Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field.
• Minimum 3 years in clinical operations or healthcare-related field. Medical training/background highly beneficial
• Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational, technical writing, and problem-solving skills. Able to interpret clinical data, meet deadlines and work effectively with all levels of employees.

• A general familiarity with cardiac, vascular technologies. Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical/hospital environment.
• Certification as a Research Professional by Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP).
• Work habits include organization, coordination of many tasks, accuracy, and attention to detail.

• 12-month contract
• Full time, 40hrs/week
• Benefits available (Medical, Dental, Vision, 401k)