Site Coordinator

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.

𑣲 Essential Functions

• 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.

𑣲 Qualifications

• Bachelor's Degree • 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 • 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