Clinical Research Coordinator 3

Summary

Perform a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and/or seeking enrollment in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP). Assist with daily workload planning.

• Provide clinical research support to investigators to prepare for and execute assigned research studies, including:
• Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data.
• Attend all relevant study meetings.
• Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research.
• Recruit and screen patients for clinical trials and maintain subject screening logs.
• Orient research subjects to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visits.
• Design and maintain source documentation based on protocol requirements.
• Schedule and execute study visits and perform study procedures.
• Collect, record and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy and completeness.
• Handle lab testing and analysis, including preparation of specimen collection tubes and lab logistics.
• Monitor subject safety and report adverse reactions to appropriate medical personnel.
• Correspond with research subjects and troubleshoot study-related questions or issues.
• Participate in huddles to confirm daily study tasks are assigned to team members and are executed to the expected standards.
• Assist with study data quality checking and query resolution.
• Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation and cardiac telemetry monitoring.
• Record, report and interpret study findings appropriately to develop a study-specific database.
• Assist investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements, clinical research regulations and quality standards.
• Provide training to new investigator site staff members on study-specific topics and requirements.
• Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records.
• Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies.
• Assist research site with coverage planning related to staffing and scheduling for research projects.

• Knowledge of clinical trials.
• In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules.
• Knowledge of medical terminology.
• Skilled in using MS Windows and Office applications such as Access, Outlook, Excel, and Word.
• Excellent interpersonal skills.
• Ability to pay close attention to detail.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

• High school diploma (a BS would be a plus) or educational equivalent and relevant work experience in a clinical environment or medical setting, or equivalent combination of education, training and experience.
• Applicable certifications and licenses as required by the company, country, state, and/or other regulatory bodies.

Pay Rate Range: $30-38/hr depending on experience