Clinical Research Coordinator

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

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

Travel: Required between offices dependent on office/location needs
Compensation: $55,000- $75,000 annually, 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.

Key Responsibilities

• Screens potential patients for protocol eligibility.
• Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trials. Coordinates patient care in compliance with protocol requirements.
• May disburse investigational drug. Maintains investigational drug accountability.
• Oversees the preparation of orders by physicians to assure that protocol compliance is maintained. Packages and ships lab specimens to central vendors where applicable. Required to complete Hazmat and/or IATA training.
• In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings and participates in data collection of all subjects.
• Responsible for preparing study-related documentation such as protocol worksheets, adverse event reports, institutional review board documents, and annual continuing review reports.
• Maintains regulatory documents in accordance with USOR SOP and applicable regulations.
• May participate in scheduling monitoring and auditing visits, as well as interact with the monitors/auditors while onsite.
• May collaborate with Research Site Leader in the study selection process.
• Participates in required training and education programs.
• May be responsible for education of clinic staff regarding clinical research. Collaborates with staff in the development of action plans and performance improvement opportunities with staff to improve quality.
• May be responsible for compiling and reporting protocol activity, accrual trends, data entry compliance, and research financial information to practice administration and physicians.
• May be responsible for reviewing protocol specific billing guides and submitting billing information to appropriate personnel.

Minimum Job Qualifications:

• Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred.
• Minimum five years of experience in a clinical or scientific related discipline required, preferably in oncology.
• SoCRA or ACRP certification preferred. Business Experience
• Experience in Microsoft Office Experience working with physicians preferred Experience working in clinical research is preferred Specialized Knowledge/Skills
• Must have excellent communication skills
• Excellent organizational skills Strong ability to multi-task Excellent time management skills
• Must have strong interpersonal skills to be able to interact with multiple people on many different levels
• Must have a high level of attention to detail Must be able to work in a fast-paced environment

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.

Minimum Job Qualifications:

• Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred.
• Minimum five years of experience in a clinical or scientific related discipline required, preferably in oncology.
• SoCRA or ACRP certification preferred. Business Experience
• Experience in Microsoft Office Experience working with physicians preferred Experience working in clinical research is preferred Specialized Knowledge/Skills
• Must have excellent communication skills
• Excellent organizational skills Strong ability to multi-task Excellent time management skills
• Must have strong interpersonal skills to be able to interact with multiple people on many different levels
• Must have a high level of attention to detail Must be able to work in a fast-paced environment

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.

Key Responsibilities

• Screens potential patients for protocol eligibility.
• Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trials. Coordinates patient care in compliance with protocol requirements.
• May disburse investigational drug. Maintains investigational drug accountability.
• Oversees the preparation of orders by physicians to assure that protocol compliance is maintained. Packages and ships lab specimens to central vendors where applicable. Required to complete Hazmat and/or IATA training.
• In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings and participates in data collection of all subjects.
• Responsible for preparing study-related documentation such as protocol worksheets, adverse event reports, institutional review board documents, and annual continuing review reports.
• Maintains regulatory documents in accordance with USOR SOP and applicable regulations.
• May participate in scheduling monitoring and auditing visits, as well as interact with the monitors/auditors while onsite.
• May collaborate with Research Site Leader in the study selection process.
• Participates in required training and education programs.
• May be responsible for education of clinic staff regarding clinical research. Collaborates with staff in the development of action plans and performance improvement opportunities with staff to improve quality.
• May be responsible for compiling and reporting protocol activity, accrual trends, data entry compliance, and research financial information to practice administration and physicians.
• May be responsible for reviewing protocol specific billing guides and submitting billing information to appropriate personnel.