Clinical Research Coordinator

PRISM Vision Group; Spokane (WA); On-site; USD 55,000 - 115,000; Full time

Job summary

PRISM Vision Group is seeking a Clinical Research Coordinator at Spokane Eye Clinic in Spokane, WA. The role involves coordinating clinical research data, patient recruitment, and study visits under physician supervision.

Responsibilities include data entry into EDC systems, coordinating with CRAs, and assisting in audits and IRB communications. A Bachelor’s degree in science or related field and 2+ years of relevant experience are preferred.

Qualifications

• Bachelor’s degree in Science or related field; equivalent experience acceptable.
• 2+ years’ relevant experience (research, clinical, study coordination)
• Knowledge of medical terminology; familiarity with GCP, FDA, HIPAA policies

Responsibilities

• Leads recruitment efforts and screens potential patients for eligibility for studies.
• Obtains informed consent and conducts study visits for clinical trials.
• Creates Case Report Forms and documents assessments per protocol.
• Enters study data into EDC systems and coordinates data collection and submission.
• Assists during Sponsor and FDA audits and IRB communications; maintains documentation.
• Travels to investigator meetings and participates in weekly team meetings.

Skills

Excel

Word

PowerPoint

Reporting

Interpersonal skills

Organizational skills

Attention to detail

Medical terminology

GCP & HIPAA

MS Office

Education

Bachelor's degree (Science or related field)

Tools

EDC systems

Job description

Overview

Position Title: Clinical Research CoordinatorEmployment Type: Full-Time, Non-Exempt

Hours: 7:30am-5pm (Monday-Friday)Practice: Spokane Eye Clinic, a PRISM Vision Group Partner PracticeLocation: Spokane, Washington

Travel: Required between offices dependent on office/location needsCompensation: $26.65 - $55.35 per hour, based on experience and qualifications

Position Summary:

The Clinical Research Coordinator reports to the Manager of Clinical Research and will aid in the coordination and conduct of research under the supervision of a designated physician. The Clinical Research Coordinator will perform a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data. The Clinical Research Coordinator has knowledge of the research studies, rationale, subjects and procedures associated with the studies.

Responsibilities

KEY RESPONSIBILITIES

• Leads recruitment efforts and screens potential patients for eligibility for studies.
• Obtains informed consent from patients and conducts study visits for clinical trials
• Creates Case Report Forms
• Completes assessments on study subjects as per protocol
• Documents study assessments
• Enters study data into EDC systems
• Collects, processes, stores and ships lab specimens; documents lab procedures, lab results and follows up with patients and medical staff as necessary
• Coordinates, monitors visits with CRAs for each trial to ensure accurate documentation; makes corrections to data as necessary
• Assists during Sponsor and FDA audits
• Responsible for submissions and reports to the IRB; maintains documentation of IRB communications and decisions
• Documents adverse events and notifies PI, sponsor and IRB
• Assumes test article accountability
• Possesses a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility
• Maintains compliance with Good Clinical Practice; Clinical Safety Data Management, 21 CFR, and has IATA certification
• Travels to investigator meetings
• Participates in weekly meetings with the research team, provides study metrics
• Responds to requests in a timely manner, gives/receives correct information, encourages dialogue and follow-through, secures accurate signatures, maintains files in an organized and up-to-date manner.

Qualifications

QUALIFICATIONS

Education: Bachelor’s degree preferably in Science or related field. Equivalent relevant experience and/or training in lieu of education is acceptable.

Experience: 2+ years’ relevant experience (e.g. research, clinical, interaction with study population, program coordination)

Knowledge/Experience/Essential Skills:

• Excellent Excel, Word, PowerPoint and reporting skills
• Excellent interpersonal skills to deal effectively with patients, physicians, clinicians and administrators
• Excellent organizational skills and self-management skills to independently manage work flow
• Ability to prioritize
• Meticulous attention to detail
• Knowledge of medical terminology
• Knowledge of good clinical practice, FDA, OHRP, HIPAA policies
• Experience using Microsoft Office Suite
• Certification through either ACRP or SoCRA highly preferred