PURPOSE

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.
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;
• 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.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Knowledge of clinical trials
• In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study
schedules
• Knowledge of medical terminology
• Skilled in using MS Windows and Office applications such as Access, Outlook, Excel, 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
• High school diploma (A BS would be a plus) or educational equivalent and 5 years’ 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

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $57,800.00 - $96,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.