Clinical Project Specialist

GForce Life Sciences; Fort Snelling Unorganized Territory (MN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401k

Job summary

GForce Life Sciences is assisting a Fortune 500 Medical Device Company to fill an entry-level Consultant, Clinical Project Specialist role in the Study Operations Project Management team. You will participate in the execution of clinical device studies, ensure compliance with protocol, GCP, and regulatory standards, and support study management activities including vendor oversight.

The role supports site investigators and clinical staff, requires a Bachelor’s degree and at least 3 years in

Qualifications

• Bachelor's degree required; natural science/pre-medicine/nursing/bioengineering or related field preferred.
• Minimum 3 years in clinical operations or healthcare-related field.
• Strong written and verbal communication, interpersonal, analytical and organizational skills.

Responsibilities

• Manage all aspects of the subject selection committee work.
• Track data entry needs and timelines to sites, core labs, and colleagues.
• Apply protocol and charter requirements to resolve discrepancies before committee review.
• Facilitate adjudications via offline email review and live teleconference calls.
• Process images with sites/core labs and assist in slide preparation for reviews.
• Communicate review status and final adjudication results to investigators and staff.
• Track consultant billing and committee member consulting time.
• Document committee decisions promptly and archive supporting documentation.
• Collaborate with study and field teams to track prospective committee cases.
• Provide feedback for study protocol sections, training, and presentations.
• Manage trial timelines and deliverables for annual database locks.

Skills

Communication

Analytical

Organizational skills

Problem-solving

Education

Bachelor's degree in natural science or related field

Job description

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.

Job Duties

• 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

Mandatory Requirements

• 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.

Nice to Have

• 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.

Terms & Start

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