IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Job Description Summary
Perform a variety of clinical procedures to collect, record, report and interpret data on volunteers enrolled and/or seeking enrollment in clinical studies according to standard operating procedures (SOPs). Monitor volunteer response to evaluate effect of investigational device. Assist with daily workload planning.
Incumbents in this job classification may work in the clinic, screening, recruitment or any other department into which they have cross trained and may be expected to perform duties not specified below. They may also specialize aspects of this job such as training, staffing or study coordination, and may not be required to carry out all responsibilities indicated below.
Collaborate with the Study Director/Coordinator to prepare for and execute assigned studies. Assist in ensuring that study objectives are met on time, within budget and according to applicable regulations and quality standards.
- Review of study protocols, case report forms (CRF), other study documents, and electronic data capture systems;
- Feedback on clinical strategy and concerns;
- Clinical set-up and preparation of the study including setting up equipment and documents;
- Planning logistical activity for procedures as per protocol;
- Generate materials, documents, and records;
- Attend or delegate all relevant study meetings including those with clients;
- Troubleshoot issues on study;
- Participate in huddles to ensure daily tasks are assigned to team members and are executed to the expected standards;
- Assist with data quality checking and query resolution.
- Orient volunteers to the study and the unit including the purpose of the study, procedures, and protocol issues such as timelines for visits and restrictions on food and drink
- Collect, record and maintain volunteer study data according to study-specific protocol and SOPs ensuring quality control for content, accuracy and completeness.
- Perform a variety of complex clinical procedures that may include but not be limited to ECG, sample collection, spirometry, vital signs, cannulation and cardiac telemetry monitoring. Record, report and interpret findings appropriately to develop study-specific database.
- Monitor volunteer safety and report adverse reactions to appropriate medical personnel. Attend to volunteer needs and requirements
- Maintain and restock medical supplies as needed. Maintain cleanliness and sanitation of the unit.
- Provide training to new staff members on study-specific topics and new clinical skills. Assist in ensuring compliance with staff training requirements by auditing and maintaining training records. Contribute to development of employees' training plans by advising Team Leads of continuing education requirements and opportunities.
- Recruit and screen volunteers for trials and maintain volunteer database.
- Participate in quality and process improvement efforts to support the culture towards a high-performing and efficient team.
- Assist with planning related to staffing and scheduling. Assist in ensuring that work shifts are staffed as required by sourcing internal staff, booking bank or PRN staff, updating the scheduling system, and notifying staff of assignments.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Working knowledge of Phase I 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
- 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
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s degree or educational equivalent; or High school diploma or 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
- Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies
- 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
- Occasional lifting and moving objects weighing up to 10 lbs/4.5 kg
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at URL blocked - click to apply to arrange for such an accommodation.Job ID:
Electronic Data Capture
Good Clinical Practices (Gcp)