Clinical Research Coordinator, On-Site

Benefits

Qualifications

• •Bachelor's Degree Or High School Diploma or equivalent industry experience
• •3 years' relevant work experience in a clinical environment or medical setting, e.g., medical assistant, assistant nurse, laboratory technician; or equivalent combination of education, training and experience Req
• •Working knowledge of clinical trials
• •Working knowledge of the principles of Good Clinical Practices (GCP)
• •In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
• •Skill in carrying out required clinical procedures such as intravenous catheter insertion and spirometry testing
• •Good skill in using MS Windows and Office applications such as Access, Outlook 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
• •Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies
• •8 more items(s)

Responsibilities

• •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
• •20 more items(s)