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Support study sites in the coordination and execution of Phase I-IV clinical research studies, ensuring compliance with study protocols, SOPs, Good Clinical Practice (GCP), and applicable regulatory requirements.

Key Responsibilities

Clinical Study Coordination

Coordinate clinical research studies under the supervision of the Principal Investigator.
Review study protocols, CRFs, study documents, and electronic data capture (EDC) systems.
Participate in study/project meetings as required.
Conduct study start-up activities and clinical setup.
Prepare study-specific training materials, documents, and records.
Troubleshoot study-related issues and support daily study operations.
Assist with data quality review and query resolution.

Volunteer Recruitment & Management

Recruit and screen study participants based on protocol-defined criteria.
Educate volunteers regarding study procedures, timelines, and expectations.
Serve as a volunteer advocate and address participant concerns proactively.
Ensure participant safety and welfare throughout the study.

Clinical Procedures

Perform and document study-related procedures including:

Phlebotomy and sample collection
Vital signs assessment
ECGs
Spirometry
Cannulation
Cardiac telemetry monitoring
Study drug administration and accountability

Data Collection & Reporting

Collect, record, and report clinical data accurately in CRFs.
Monitor and report Adverse Events (AEs) and Serious Adverse Events (SAEs).
Collaborate closely with investigators and study monitors.
Support monitoring visits and audits.

Quality & Compliance

Ensure compliance with:
- Good Clinical Practice (GCP)
- Study protocols
- Site SOPs
- Regulatory requirements
Maintain study documentation and records.
Identify and report protocol deviations.
Support quality control and data integrity initiatives.

Team Support

Participate in daily huddles and study planning activities.
Assist nursing and clinical staff in delivering participant care.
Maintain knowledge of current clinical research practices and nursing standards.

Required Skills & Knowledge

Must-Have

Clinical trial experience (Phase I-IV preferred)
Strong understanding of Good Clinical Practice (GCP)
Clinical research coordination experience
Participant recruitment and screening
Clinical data collection and documentation
Adverse Event (AE) and Serious Adverse Event (SAE) reporting
Phlebotomy and specimen collection
ECG administration
Vital signs monitoring

Technical Skills

Electronic Data Capture (EDC) systems
MS Office Suite
Windows-based applications
Clinical documentation and CRFs

Soft Skills

Excellent communication skills
Strong interpersonal skills
Attention to detail
Problem-solving ability
Organizational and time management skills
Ability to work collaboratively with investigators, sponsors, monitors, and study participants

Education & Certifications

Required

Bachelor's Degree in Nursing (BNSc, BScN, RN) or equivalent
Active nursing license in the applicable province/state/country
Relevant clinical research experience (minimum 1 year)

Preferred

GCP Certification
Clinical Research Coordinator (CRC) experience
Phase I clinical trial experience

Applicant Notices & Disclaimers

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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 50.00/hr.