Clinical Research Coordinator – Iowa Clinic, Des Moines, IA

Job Location:

The Iowa Clinic - Des Moines, IA 50266

Position Type:
Full Time

Education Level: Bachelor's Degree

Job Shift: Day

A Clinical Research Coordinator (CRC) is responsible for reviewing, processing, and managing clinical research data and documents, both regulatory and patient records. The CRC performs a variety of clinical procedures, and assists with daily workload planning; i.e collection, recording, reporting, and interpreting data on patients enrolled in and/or seeking enrollment in clinical studies according to the protocol, SOPs, and GCPs.

• Provide clinical research support to investigators to prepare for and execute assigned research studies, including:
  • Collect, record, and maintain research subject study data according to study protocols and SOPs, preserving quality control for content, accuracy, and completeness.
  • Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research.
  • Recruit and screen participants for clinical trials and maintain subject screening logs.
  • Assist in the initial and ongoing consent process; orient research subjects to the study, including the purpose of the study, procedures, and research process.
  • Maintain source documentation based on protocol requirements.
  • Schedule and execute study visits and perform study procedures.
  • Handle lab testing and analysis, including preparation of specimen collection tubes, shipment, and lab logistics.
  • Monitor subject safety and report adverse events/reactions to the Principal Investigator and/or 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, if needed.
• Assist the 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 the research site with coverage planning related to staffing and scheduling for research studies.
• Maintain confidentiality of data and PHI as required.
• Collaborate with provider offices to carry out research in the most efficient workflow possible.
• Maintain stock of supplies needed to carry out each study per protocol.
• Perform other duties and projects as assigned.

• Bachelor's degree in a related field1-2 years of clinical research experience
• 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
• Proficient in the use of Microsoft Office applications
• Understanding of medical terminology
• Working knowledge of clinical trials
• Knowledge and ability to apply GCP/ICH and all applicable FDA regulations and guidelines for human subject protection, drug, and device
• In-depth knowledge of departmental, protocol, and study‑specific operating procedures, consent forms, and study schedules
• Skilled in carrying out required clinical procedures such as phlebotomy and vital signs
• Strong written and verbal communication skills including good command of the English language
• Skill in applying and modifying professional research principles, methods, and techniques to provide ongoing patient care
• Skill in preparing/maintaining records, writing reports, and responding to correspondence
• Ability to maintain quality control standards
• Ability to react calmly…