Job Description

Job Description

Job Description

ESSENTIAL FUNCTIONS

• Reviews potential protocols to evaluate their feasibility and advises on implementation within standard clinical practices
• Recruits study participants by referrals from clinical sites; schedules appointments, interviews and evaluates potential participants to ensure they meet eligibility requirements; instructs participants concerning protocol and obtains informed consent
• Monitors and participates in research activities including data collection, data entry and analysis for a research project
• Schedules and/or coordinates the scheduling of required laboratory tests and/or radiographic exams
• Assists in developing patient educational materials and provides patient and/or family members with instructions on investigational drug/device administration and other pertinent information related to study participation
• Assists in preparing forms for submission to appropriate oversight/regulatory committees
• Is the primary resource to clinical and support staff within the scope of the study; ensures adherence to clinical and imaging protocols, scheduling study visits within protocol windows, appropriate sites of service for study activities
• Prepares and submits study related reports to sponsors, institutional review boards and other parties as required
• Hosts sponsor visits for qualification, initiation, and monitoring of sponsored studies
• Completes case report forms for study participants and documents applicable data in study records/databases.
• Inventories and requisitions research study supplies and equipment
• Works with research accounting to ensure appropriate billing of research activities
• Conducts clinical research in compliance with all applicable SOPs, laws and standards (e.g. GCP and human subject protections)

EDUCATION

• Associate Degree with two years of clinical trial experience or Bachelor's degree in related medical field

EXPERIENCE

• Two plus years’ experience in the health care field or an equivalent combination of education and experience.

REQUIREMENTS

• None

KNOWLEDGE

• Knowledge of the principles, practices and techniques of clinical care
• Knowledge of clinic policies and procedures
• Knowledge of computer systems and applications, including but not limited to Microsoft Office and Electronic Data Capture systems
• Knowledge of medical practices, terminology
• Knowledge of organizational policies and procedures
• Knowledge of clinical research regulatory guidelines and regulations

SKILLS

• Skill in planning and organizing clinical trials
• Skill in evaluating effectiveness of existing methods and procedures
• Skill in communicating with internal and external customers

ABILITIES

• Ability to communicate clearly and effectively
• Ability to set priorities among multiple projects
• Ability to interact with providers, clinic and hospital staff

ENVIRONMENTAL WORKING CONDITIONS

• Normal office environment.
• Work in clinical and hospital environments
• Some travel within community.

PHYSICAL/MENTAL DEMANDS

• Requires sitting and standing associated with a normal office environment.
• Some bending and stretching required.
• Manual dexterity using a calculator and computer keyboard.

ORGANIZATIONAL REQUIREMENTS

• HOPCo Mission, Vision and Values must be read and signed.

This description is intended to provide only basic guidelines for meeting job requirements. Responsibilities, knowledge, skills, abilities and working conditions may change as needs evolve.

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