Clinical Research Assistant

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

Hours: 8 am-5pm (Monday-Friday) Practice: Retina Group of Washington , a PRISM Vision Group Partner Practice Location: FairFax, Virginia

Travel: Required between offices dependent on office/location needs Compensation: $22.44-$46.62 based on experience and qualifications

Position Summary:

The Clinical Research Assistant reports to the RGW Office Manager and RGW Research Lead 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.

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:

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

WORK ENVIRONMENT

An office environment with a controlled atmosphere. Possible exposure to staff or patients with communicable diseases and blood borne pathogens.

OTHER PHYSICAL REQUIREMENTS

Vision (Near, Distance, Color, Peripheral, Depth Perception), normal range of hearing, ability to wear Personal Protective Equipment (PPE) (gloves, face mask, eye shield, gown), standing for long periods of time.

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:

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

WORK ENVIRONMENT

An office environment with a controlled atmosphere. Possible exposure to staff or patients with communicable diseases and blood borne pathogens.

OTHER PHYSICAL REQUIREMENTS

Vision (Near, Distance, Color, Peripheral, Depth Perception), normal range of hearing, ability to wear Personal Protective Equipment (PPE) (gloves, face mask, eye shield, gown), standing for long periods of time.