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Job Description

Summarized Purpose:

Assists with managing various aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings. Acts as liaison between senior project team members and study subjects. Actively participates and assists with sponsor, investigator and research team communications.

Essential Functions • Actively participates with senior project team members to meet project needs, projections and deadlines. • Oversees organization and accuracy of project documents. • Works with management on understanding departmental needs and improving processes. • Provides support for the study conduct, working directly with study monitor and study subjects. • Oversees data entry, source data QC, EDC data entry and EDC query resolution, lab data verification, subject eligibility status review and subject eligibility notification.

Job Complexity Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.

Job Knowledge Learns to use professional concepts. Applies company policies and procedures to resolve routine issues.

Supervision Received Normally receives detailed instructions on all work.

Business Relationships Contacts are primarily with immediate supervisor, and other personnel in the department. Builds stable working relationships internally.

Qualifications:

Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities: • Basic knowledge of Phase I processes and clinical study operations • Fundamental knowledge of FDA regulations and ICH GCP guidelines • Basic computer skills with working knowledge of Microsoft Office applications • Time management and multi-tasking skills • Written and verbal communication skills • Ability to prioritize workload and adapt to changing study needs • Ability to act as a liaison between external and internal groups

Management Role: No management responsibility

Working Conditions and Environment: • Work is performed in an office/ laboratory and/or a clinical environment. • Exposure to biological fluids with potential exposure to infectious organisms. • Exposure to electrical office equipment. • Personal protective equipment required such as protective eyewear, garments and gloves.

Physical Requirements: • Ability to work in an upright and /or stationary position for 6-8 hours per day. • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. • Frequent mobility required. • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. • Ability to access and use a variety of computer software developed both in-house and off-the-shelf. • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. • Frequently interacts with others to obtain or relate information to diverse groups. • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. • Regular and consistent attendance.