Oncology Study Coordinator

2 days ago

Johannesburg, South Africa IQVIA Full time

IQVIA is looking for a Study Coordinator with experience in **ONCOLOGY **based in the **Gauteng, Johannesburg.**

**This is a 2 year fixed term contract.**

**3 years minimum experience as a Study Coordinator is required and non-negotiable.**

**RESPONSIBILITIES**
- 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
- Design and 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 and lab logistics
- 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
- 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

**SKILLS**
- Knowledge of clinical trials: In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
- Knowledge of medical terminology
- Excellent interpersonal skills
- Ability to pay close attention to detail
- Ability to establish and maintain effective working relationships with coworkers, managers and clients

**EDUCATION AND EXPERIENCE**
- BS/BA in life sciences or educational equivalent and relevant work experience in a clinical environment or medical setting; or equivalent combination of education, training and experience
- Applicable certifications and licenses as required by the company, country, state, and/or other regulatory bodies.
- **3 years minimum experience as a Study Coordinator is required and non-negotiable.**

**PHYSICAL REQUIREMENTS**
- Use of telephone and face-to-face communication requiring accurate perception of speech
- Use of keyboard requiring repetitive motion of fingers
- Frequent mobilization around the facility

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