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 fieldEXPERIENCE
Two plus years’ experience in the health care field or an equivalent combination of education and experience.REQUIREMENTS
NoneKNOWLEDGE
Knowledge of the principles, practices and techniques of clinical careKnowledge of clinic policies and proceduresKnowledge of computer systems and applications, including but not limited to Microsoft Office and Electronic Data Capture systemsKnowledge of medical practices, terminologyKnowledge of organizational policies and proceduresKnowledge of clinical research regulatory guidelines and regulationsSKILLS
Skill in planning and organizing clinical trialsSkill in evaluating effectiveness of existing methods and proceduresSkill in communicating with internal and external customersABILITIES
Ability to communicate clearly and effectivelyAbility to set priorities among multiple projectsAbility to interact with providers, clinic and hospital staffENVIRONMENTAL WORKING CONDITIONS
Normal office environment.Work in clinical and hospital environmentsSome 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.