IQVIA Clinical Research Coordinator Job – Apply Online
Bengaluru, India
Full-time
R1463146
Job Description
Job Overview
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 executed to 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 investigators 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 sites 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 the company, country, state, and/or other regulatory bodies (Required).
Keywords: IQVIA, Clinical Research Coordinator, Bengaluru, India, Job, Full-time, Clinical Trials, GCP, Medical Assistant, Laboratory Technician, Training, monitoring visits. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebo