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
Job Types: Part-time, Temporary
Contract length: 4 months
Pay: £20.00-£25.00 per hour
Expected hours: 24 per week
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
- Night shift
Experience:
- Clinical experience: blood draws, ECGs, spirometry: 1 year (required)