Research Coordinator - Clinical Research Institute - Full Time 8 Hours Day (Non-Union, Non-Exempt)

Assists investigators or other staff with research studies in subject recruitment, data collection, scheduling of study-related activities, and follow-up of enrolled subjects.

Responsibilities

• Assists with organizing and scheduling assessments, tests, and activities to meet research objectives and study protocol compliance.
• Communicates with study team personnel to ensure study procedures are followed and research is performed as described in protocol.
• Serves as contact for subjects, study personnel, Institutional Review Board (IRB), and study sponsor.
• Participates in assessing patient eligibility.
• Assists in coordinating study participant activities including recruitment, screening, orientation, and correspondence.
• Schedules subject appointments, tests, and procedures, coordinating with external providers as needed.
• Produces reports and other materials as directed.
• Assists with data collection for research studies following established data collection and management procedures.
• Collects, records, enters, and prepares data for analysis.
• Performs preliminary study analysis under the direction of the Principal Investigator or senior coordinators.
• Collects pertinent information from study participants through interviews, administration of tests or surveys, medical records review, or other collection procedures.
• Maintains accurate, complete, and timely records, including source documents, consent forms, case report forms, protocol documents, and regulatory documents, as required by sponsor and institutional guidelines.
• Assists in organization and preparation of grant proposals, including gathering documentation such as annual reports and detailed budgets.
• Assists investigators in developing research proposals.
• Interfaces with funding and regulatory agencies to exchange information.
• Assists with submission of timely, accurate, and complete study continuing review, amendments, and reportable events to IRB.
• Serves as regulatory coordinator for study sponsors and the IRB.
• Ensures consent process is performed and documented in compliance with FDA, GCP, IRB, HIPAA, SOPs, sponsor, and institutional regulations and policies.
• Provides ongoing education to study subjects about clinical trials and significant new information that may affect a subject's willingness to participate.
• Evaluates subject compliance and promotes compliance through education.
• Assists in the preparation of site for monitor visits and external/internal audits.
• Provides timely response to queries from sponsor and/or auditors.
• Collaborates with pharmacist or materials management personnel to maintain accurate accountability of investigational products and specimens.
• Assists with sample collection, processing, and shipment for each study.
• Updates automated databases and other records for reporting and compliance purposes.
• Generates reports and analysis of data according to project schedules or on an ad hoc basis.
• Assists by arranging and attending meetings, seminars, symposia, and other events related to project efforts.
• Participates in educational opportunities to increase knowledge about clinical trials and regulations.
• Remains current with federal, state, and institutional regulations and best practices.
• Orders supplies and equipment; researches and develops recommendations for new equipment purchases.
• Completes Research Order Form (ROF) for each subject visit and submits subject enrollment documentation as required.
• Performs other related duties as assigned or requested.

Requirements

• Bachelor’s Degree or combined experience/education as substitute for minimum education.
• 2 years of administrative or research experience.
• Working knowledge of MS Office applications.
• Human Subjects Research (HSR) Training Certification from CITI Program.
• Information Privacy Security (IPS) Research HIPAA 1 Basic Certification from CITI Program.
• Good Clinical Practice (GCP) Training Certification from CITI Program.

Preferred Qualifications

• 2 years of experience in a medical environment with knowledge of medical terminology.
• CCRC (Certified Clinical Research Coordinator) certification from ACRP.

Skills

• Demonstrated effective communication and writing skills.
• Ability to multi-task and prioritize.
• Demonstrated ability to work as part of a team as well as independently.
• Clinical documentation skills.
• Ability to communicate with others to gather information.
• Understanding and enforcement of regulatory guidelines.
• Proficiency in database and/or word processing software.

Pay

The hourly rate range for this position is $34.32 - $56.19. When extending an offer of employment, factors such as (but not limited to) the scope and responsibilities of the position, the candidate’s work experience, education/training, key skills, internal peer equity, federal, State, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations are taken into account.