Clinical Research Coordinator

JOB SUMMARY

A Research Coordinator 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; ie; collect, record, report, and interpret data on patients enrolled in and/or seeking enrollment in clinical studies according to the protocol, SOPs and GCPs.

ESSENTIAL DUTIES/RESPONSIBILITIES

• 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 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 studies.
• Performs other duties and projects as assigned.

Required:

• Bachelor's degree in a related field
• 1-2 years’ Clinical research experience

Preferred:

• 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
• Strong organizational skills

SKILLS AND ABILITIES

• 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.
• Excellent organizational and problem-solving skills.
• Effective time management skills with the ability to multi-task and manage competing priorities with exceptional attention to details.
• Ability to establish and maintain effective working relationships with physicians, coworkers, managers, and clients.
• Practice a high level of integrity, honesty, and in maintaining confidentiality.