What are the responsibilities and job description for the Clinical Research Coordinator position at The Center for Orthopedic and Research E?
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
EXPERIENCE
REQUIREMENTS
KNOWLEDGE
SKILLS
ABILITIES
ENVIRONMENTAL WORKING CONDITIONS
PHYSICAL / MENTAL DEMANDS
ORGANIZATIONAL REQUIREMENTS
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.
