Clinical Research Assistant

SUMMARY:

Coordinates and facilitates management of the day-to-day clinical activities for specified research trials in accordance with the research parameters established by the Principle Investigator (PI). The Research Assistant (RA) promotes good clinical practices in the conduct of investigations by possessing an in-depth knowledge of federal regulations and guidance documents for the conduct of clinical trials and human subject protection. The RA conducts clinical tasks per protocol and as delegated by the PI and sponsoring organizations. The RA assures compliance with protocol and regulatory requirements, by collecting, recording, and maintaining data and source documentation. The RA will work closely with the Clinical Research Staff, department members, study sponsors, and the institution, to support administration of the compliance, personnel and other related aspects of all ongoing clinical studies.

ESSENTIAL FUNCTIONS :

Facilitate and coordinate daily clinical activities; the position plays a critical role in the conduct of all studies.

Act as liaison between PI’s, ancillary departments, research subjects, sponsoring organizations and regulating bodies , vendors, brokers, and suppliers of products and services.

With program participants; conduct interviews, schedule participant appointments, administer surveys for research purposes, collect and aggregate data, and act as patient liaison for the PI.

Serve as a member of the research team.

Maintains required documentation including source documentation, subject logs, various records, reports, and other essential documents.

Data mining and data entry.

Adheres to TMCH organizational and department-specific safety, confidentiality, values, policies and standards.

Performs related duties as assigned.

MINIMUM QUALIFICATIONS

EDUCATION: Associate’s degree specializing in medical assistance, phlebotomy, or related field; or any equivalent combination of experience, training and/or education approved by Human Resources.

EXPEREINCE: Associate’s degree in a field appropriate to the area of assignment AND two years related research experience; OR, six years research experience appropriate to the area of assignment; OR, any equivalent combination of experience, training and/or education approved by Human Resources.

LICENSURE OR CERTIFICATION: None required.

KNOWLEDGE, SKILLS AND ABILITIES :

• Thorough knowledge of benefits theory, practices, and tools utilized (preferably within the hospital or healthcare industry) is required.
• Above-average skill in the use of all Microsoft Office applications (ex: Excel, PowerPoint, etc required; familiarity with spreadsheets and statistical data is necessary (as will be related to quality improvement and tracking projects).
• Knowledge of nursing care and assessment best practices as well as related clinical components.
• Knowledge of regulations and policies as it relates to patient research, evaluation, care and information.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Highly organized and able to multi-task.
• Ability to write reports, correspondence, and procedure protocols.
• Ability to effectively present information and respond to inquiries or complaints from patients and/or their representatives, and the general public.
• Ability to work with concepts such as fractions, percentages, ratios, and proportions, and to apply mathematical operations to solve or analyze job-related situations.
• Requires problem solving, decision-making, critical thinking, analytical, and deduction skills.
• Ability to work with diverse populations and adjust approaches as needed. Demonstrated compassion, integrity and ability to work with a wide range of disciplines.
• Ability to be sympathetic, culturally sensitive and emotionally supportive to the patient/family throughout the care continuum.
• Must maintain a positive and professional attitude through stressful situations.
• Must be able to work in a self-directed environment, with an ability to work with teams.
• Excellent presentation skills; ability to implement professional and community based education programs.