Clinical Research Assistant (103855)

Duties and Responsibilities (Responsibilities necessary to accomplish job functions)

• Assists coordinators with patient visits including scheduling/tracking, data acquisition/data entry, procedures such as biopsies, administration of photodynamic therapy, adhesive lesional stripping, and related tasks.
• Assists with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
• Assists physicians with patient care and treatment assisting with instruments, injections, and suture removal
• Collects EKGs and vital signs
• Assists clinical trials coordinator and principal investigator with initiation and maintenance of study protocols
• Assists with study visits per study protocol, inclusive of source document and case report form completion and submission
• Performs laboratory duties and functions related to study protocols.
• Ensured clinical trial files are documented in accordance with company standard operating procedures, study protocol and Good Clinical Practice.
• Reviews exclusion/inclusion criteria with the Principal Investigator or Lead Coordinator to ensure subject eligibility
• Process blood, urine, and biopsy samples in accordance with study protocols and IATA/ OSHA standards
• Stocks and organizes medical supplies in exam rooms as needed. Notify appropriate personnel when supplies are needed
• Screen potential research participants and clinical patients for enrollment
• Working knowledge, at minimum, of all applicable protocols. Some team members may be assigned as the primary coordinator for a specific protocol, and should therefore have in-depth knowledge of that protocol
• Adheres to all safety policies and procedures in performing job duties and responsibilities while supporting a culture of high quality and great customer service.
• Performs other duties that may be necessary or in the best interest of the organization.

Experience Requirements

• 4 years / Bachelor’s Degree, includes but not limited to life sciences or social sciences
• Medical assistant or equivalent clinical experience; at least 1 year of experience that is directly related to the duties and responsibilities specified, preferred

Knowledge, Skills and Abilities Requirements

• Meticulously detail oriented, professional attitude, reliable
• Organizational skills to support accurate record-keeping
• Ability to follow verbal & written instructions
• Interpersonal skills to work as a team with patients and outside parties
• Able to communicate effectively in English, both verbally and in writing, with proper grammar and spelling skills to avoid mistakes or misinterpretations
• Mathematical and analytical ability for basic to intermediate problem solving
• Basic to intermediate computer operation
• Proficiency with Microsoft Excel, Word, and Outlook
• Specialty knowledge of systems relating to job function
• Knowledge of state and federal regulations such as ICH GCP, IATA; general understanding of HIPAA guidelines

Supervisory Responsibilities:

• This position has no supervisory responsibilities.