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.

Qualifications

Experience Requirements

- 4 years / Bachelors 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.