Clinical Research Assistant

A Clinical Research Assistant, or CRA, is responsible for organizing and overseeing clinical studies or trials to contribute to advances in the medical community. Their duties include contacting individuals to participate in trials, reviewing medical histories of each participant before approval and writing reports to determine the overall success of a new drug, procedure or medical device. CRAs typically work for research facilities, clinical agencies and pharmaceutical companies to coordinate clinical trials. They work closely with other clinical research professionals to test new drugs, procedures and biotechnology that could benefit modern medical practices and patient ailments. Their job is to analyze the potential risks of the trial and consult with other professionals to determine what safety protocols to use.

They may also be responsible for establishing and maintaining relationships with data management facilities to provide study or trial results.

Responsibilities

• Supervise study sites and activities to ensure adherence to appropriate industry protocols and terms of the study
• Collect and authenticate data collection forms otherwise known as case report forms
• Screen potential study participants through medical record reviews, interviews and follow-ups with healthcare providers
• Ability to escalate potential safety issues to the appropriate clinical research personnel
• Maintain specific records of research activity to include regulatory forms, drug dispensation records, case reports and consent forms
• Ensure proper transmission of clinical case data to the data management centers, review case reports questions and problems and clarify or obtain alterations to data as appropriate
• Oversee research, technical and administrative staff, to include training, hiring, goal setting and distribution of workload
• Provides administrative support to ensure efficient operation of office
• Assists with patient care and collection of medical history, medications and other data necessary for conducting clinical trials
• Data entry into medical records
• Exhibits polite and professional communication via phone, e-mail, and mail
• Supports team by performing tasks related to organization and strong communication
• Provides information by answering questions and requests
• Maintains supplies inventory by checking stock to determine inventory level, anticipating needed supplies, and placing and expediting orders for supplies
• Contributes to team effort by accomplishing related results as needed
• Performs various medical procedures including (not limited to): patient vitals, phlebotomy, run labs, EKG, etc.

• Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable
• Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects
• Understand basic elements of regulatory documentation
• Maintain confidentiality of patient protected health information, sponsor confidential information and CARE confidential information
• Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed
• Prepare source document charts, copy and/or file medical records and study related documents as required.
• Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems.
• Other duties as assigned

Skills and Qualifications

• Strong written and oral communication skills
• Excels at handling frequent task switching with efficiency
• Ability to build effective relationships with trial center colleagues and staff
• Superior problem solving, deductive reasoning and decision-making skills
• Good time management and ability to prioritize tasks and accomplish set goals efficiently
• Knowledge of statistical data collection, validation, editing and analysis techniques
• Ability to provide technical guidance, advice and support to professional staff where needed
• Knowledge of laboratory certification processes and standards
• Excellent attention to detail and ability to maintain detailed and accurate records
• Demonstrates a willingness to seek clarification without hesitation
• Administrative Writing Skills
• Microsoft Office Skills
• Strong ability to organize workflows, schedules, and information efficiently
• Professionalism, reliability, and strong interpersonal skills
• Demonstrate knowledge of medical terminology

Education & Experience Requirements

• High school diploma or equivalent education required.
• Medical office and patient care experience required.
• 3 years of administrative assistant experience preferred.
• Knowledge of appropriate software including Microsoft Word, Excel, Outlook, Microsoft PowerPoint, and Adobe Acrobat
• Valid driver's license and current automobile insurance

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

The employee must have the ability to lift, pull, push, and manipulate equipment and patients, which requires strength and gross motor and fine motor coordination. The employee must be able to administer prescribed treatments. The position requires sitting and/or standing for long periods of time. The position requires the ability to operate a computer.

Job Type:

• Monday to Friday
• $17.00 - $21.00/ hour
• In person

Benefits:

• 401(k)
• 401(k) matching
• Paid time off
• Potential bonus pay after 90-day probationary period