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Clinical Research Coordinator

Job Details

Wilmington Health - Wilmington, NC
Full Time
Bachelor's Degree
$48,000.00 - $65,000.00 Salary
Day

Description

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.

 

Qualifications

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.
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