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 dataAttend all relevant study meetingsCollect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical researchRecruit and screen patients for clinical trials and maintain subject screening logsOrient research subjects to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visitsDesign and maintain source documentation based on protocol requirements;Schedule and execute study visits and perform study proceduresCollect, record and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy and completenessHandle lab testing and analysis, including preparation of specimen collection tubes and lab logisticsMonitor subject safety and report adverse reactions to appropriate medical personnelCorrespond with research subjects and troubleshoot study-related questions or issuesParticipate in “huddles” to confirm daily study tasks are assigned to team members and are executed to the expected standardsAssist 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.

Qualifications

Bachelor's Degree Or High School Diploma or equivalent industry experience3 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 ReqWorking knowledge of clinical trialsWorking knowledge of the principles of Good Clinical Practices (GCP)In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedulesSkill in carrying out required clinical procedures such as intravenous catheter insertion and spirometry testingGood skill in using MS Windows and Office applications such as Access, Outlook and WordExcellent interpersonal skillsAbility to pay close attention to detailAbility to establish and maintain effective working relationships with coworkers, managers and clientsApplicable certifications and licenses as required by company, country, state, and/or other regulatory bodies  

 

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $36,600.00 - $106,800.00. 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.