Clinical Research Assistant

PRISM Vision Group; Merrifield (VA); On-site; USD 30,000 - 63,000; Full time

Job summary

PRISM Vision Group’s Retina Group of Washington in Fairfax, VA is seeking a Clinical Research Assistant to support coordination and conduct of clinical studies under physician supervision. This onsite, non-exempt role involves data collection, documentation, and analysis, with travel between locations as needed.

You will assist with patient screening, informed consent, CRFs, data entry into EDC, and coordinating study visits, while ensuring compliance with GCP, FDA, HIPAA policies.

Qualifications

• Associates or Bachelors Degree preferred in Science or related field; experience in lieu of education acceptable.
• 1+ years' relevant experience (e.g. research, clinical, interaction with study population, program coordination)
• Excellent Excel, Word, PowerPoint and reporting skills
• Knowledge of medical terminology and GCP, FDA, OHRP, HIPAA policies

Responsibilities

• Assist in recruitment efforts to screen potential patients for eligibility for studies.
• Obtain informed consent from patients and conduct study visits for clinical trials.
• Create Case Report Forms (CRFs).
• Complete assessments on study subjects per protocol and document study assessments.
• Enter study data into EDC systems and maintain study records.
• Coordinate, monitor visits with CRAs and assist during audits.
• Maintain IRB communications and adverse event documentation as CRC.

Skills

Excel

Word

PowerPoint

Reporting

Interpersonal skills

Organizational skills

Prioritization

Attention to detail

Medical terminology

GCP FDA HIPAA knowledge

Microsoft Office Suite

Education

Associates or Bachelors Degree

Tools

EDC systems

Microsoft Office Suite

Job description

Overview

This non-exempt, onsite role is located at Retina Group of Washington, Fairfax, VA location, which is part of Prism Vision Group.

Compensation Range: $22.44 - $46.62/hr (Dependent on Experience)

The Clinical Research Assistant reports to the RGW Office Manager and RGWResearchLead and will aid in the coordination and conduct of research under the supervision of a designated physician. The Clinical Research Assistant will perform a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data. The Clinical Research Assistant will develop knowledge of the research studies, rationale, subjects and procedures associated with the studies as designated by the Senior/Lead Clinical Research Coordinator. This position is designed specifically to develop into a Clinical Research Coordinator and travels between multiple locations as needed.

Responsibilities

Role and Responsibilities:

• Assists in recruitment efforts to screen 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 shipslab 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 under CRC guidance
• 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: Associates or Bachelors Degree preferred in Science or related field. Equivalent relevant experience and/or training in lieu of education is acceptable.

Experience: 1+ years' relevant experience (e.g. research, clinical, interaction with study population, program coordination)

Knowledge/Skills/Experience:

• 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 workflow
• 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