Research Assistant II

Work Schedule

Environmental Conditions

Job Description

Under general supervision of the Research Team Leader, the Research Assistant II is responsible for the successful conduction of multiple ongoing clinical trials involving patients or healthy volunteers/subjects. Completes of all paperwork required to accurately capture all data specified by a study protocol, and for assuring subject safety, understanding, and cooperation during the study process.

• Accountable for understanding and accomplishing the overall plan for study conduct for multiple assigned studies in order to assure successful study completion with clean and accurate data for submittal to sponsor.

• Reviews assigned study protocols, case report forms and investigator's brochure and interfacing with the Team Leader and Project Manager to clarify any study questions prior to study start.

• Prepares accurate data collection sheets, dosing regimens, specimen harvest logs (e.g. blood, urine, fecal, and other specimens), and any other study documentation needed.

• Works with the Team Leader to ensure study flow chart and technician requirements accurately reflect the study design and to assure staffing and equipment needs for the study are met.

• Communicates and works with the Pharmacy, Food Service, Materials Management, Training Team and Laboratory staff to assure proper support from these areas.

• Keeps Team Leader and Project Manager apprised of study progress, status, and of any issues that require their attention.

• Monitors the day-to-day safety and well being of all study participants through direct and indirect interaction with subjects. Performs accurate clinical assessments of subjects, monitors laboratory safety reports, communicates information regarding serious or potentially serious adverse events to the Project Manager and/or physician in charge. Monitors and continuous evaluation of the overall research experience for each study participant, while ensuring participants are properly consented and informed at all times. Submits authorization for payment of stipend to subjects. Complies with FDA and company guidelines (i.e., ICH-GCP, PPD SOPs, personnel policies and procedures, WPDs, PPD exposure control plan, OSHA regulations, and clinical laboratory requirements for submitting samples) in order to assure proper study conduction and employee and subject safety.

• Job Complexity

• Works on assignments that are semi-routine in nature but recognizes

• Demonstrated ability managing multiple responsibilities and completion of projects in either a work or school setting
• General computer skills including working knowledge of Microsoft Office and the ability to learn new software, systems, databases
• Effective problem-solving skills. Good mediation skills. Ability to function with multiple types of individuals in potentially difficult or uncomfortable settings
• Ability to exercise good judgment and to maintain confidentiality
• Effective time-management skills
• Attention to detail. Strong planning and organizational capabilities to manage multiple tasks and multiple study groups at one time
• Ability and willingness to learn to administer investigational drugs or test investigational devices. This may include dosing orally, intravenously, topically, or other approved methods of dosing
• Ability to work well in a team environment and follow all internal departmental procedures