Senior Clinical Research Coordinator

2 weeks ago

Des Moines, United States CYNET SYSTEMS Full time
Job Description:

Responsibilities:
  • 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, Skills and Abilities:
  • 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.
Education and Experience:
  • 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 other regulatory bodies.

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