Clinical Research Coordinator

Unity Systems
Lisburn
8 months ago
Applications closed

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Title:Clinical Research Coordinator

Duration:Part-time contract until Sep 2025

Location:The resource must be able to travel to client site in Belfast. The site is in Linenhall Street, Belfast.

IR35 Determination:Inside

RTW:Must hold valid UK RTW, sponsorship not provided

Hours:24 hours/week


Job Description:

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.


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.


Qualifications:

  • Bachelor’s Degree Required Or
  • High School Diploma or equivalent Required
  • 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 Required
  • 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

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