Clinical Research Assistant

Description:

GENERAL SUMMARY OF DUTIES:

Research Assistant coordinates and supports the clinical site in planning and executing multiple phase clinical trials.

SUPERVISION RECEIVED:

Clinical Research Coordinator and Principal Investigator

SUPERVISION EXERCISED:

N/A

ESSENTIAL FUNCTIONS:

• Works with Clinical Research Coordinator to perform study activities related to pre-trial assessment(s), start up, active phase and the closeout. This includes preparing and submitting sponsor and regulatory documents; recruiting and pre-screening participants; collecting study data, including specimen samples, according to identified protocols and organizing and managing it in study folders/binders, whether manually and/or electronically.
• Participates in pre-trial assessments, initiation visits and investigator meetings, as appropriate and assists in communicating with and coordinating visits by study monitors.
• Processes regulatory packets for submission to the sponsor. This may include obtaining patient signatures for protocols/ amendments, updating consent forms with site specific information, collecting completed FDA forms, updated C.V.s and medical licenses for investigators and other personnel involved in studies, and responding to requests related to advertisements, indemnification, completed W-9 Forms, appropriate signatures on Clinical Trial Agreements, correspondence/questionnaires to IRB requesting review and approval for site and site information form.
• Attends IRB meetings when necessary.

Requirements:

EDUCATION:

Bachelor’s degree in science or health-related field preferred

EXPERIENCE:

Two years clinical research experience desired

REQUIREMENTS:

Clinical research certification (ACRP or SOCRA preferred).

KNOWLEDGE AND SKILL REQUIREMENTS:

• Knowledge of all applicable laws, policies and procedures with regard to research.
• Knowledge of common safety hazards and precautions to establish/maintain a safe work environment.
• Skill in applying and modifying the principles, methods and techniques of professional research to provide ongoing patient care.
• Skill in identifying problems and recommending solutions.
• Skill in preparing/maintaining records, writing reports and responding to correspondence.
• Ability to maintain quality control standards.
• Ability to react calmly and effectively in all situations.
• Ability to communicate clearly

ENVIRONMENTAL/WORKING CONDITIONS:

Combination of office and exam settings. May involve frequent exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations and other conditions common to a clinic environment.

PHYSICAL/MENTAL DEMANDS:

Varied activities including standing, walking, reaching, bending, lifting. Requires full range of body motion including handling and lifting patients, manual and finger dexterity and eye-hand coordination. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 100 pounds. Requires corrected vision and hearing to normal range. Requires working under stressful conditions or working irregular hours.