Job Overview
Work as an integral member of investigator site staff managing the day-to-day coordination and execution of clinical studies in accordance with the protocol, contracted scope of work, good clinical practice, sponsor and standard operating procedures (SOPs) and any relevant local guidelines and regulations.
Essential Functions
Provide clinical research support to investigators to prepare for and execute assigned research studies
Review study protocols, source document forms, other study-specific documents, and electronic data capture systems used to record clinical research data
Collect and submit regulatory/ethics documentation as required by the Federal Drug Administration (FDA) and other regulatory bodies governing the conduct of the study
Recruit and screen patients for clinical trials and maintain subject screening and enrollment logs
Orient research subjects to the study including the purpose of the study, procedures and protocol requirements such as timeline for visits
Maintain source documentation based on protocol requirements that adhere to Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) documentation principles
Schedule and execute study visits and perform study procedures as delegated and supervised by the Principal Investigator
Handle lab testing and analysis including preparation of specimen collection tubes and lab logistics
Monitor subject safety and reports adverse events and reactions to Principal Investigator, study team members and IRBs as appropriate
Correspond with research subjects to troubleshoot study-related questions or concerns
Participate in routine meetings with site study staff and Investigators to confirm study tasks are assigned and are executed to the expected standards
Actively involved in study data quality checking and query resolution
Perform a variety of complex clinical research procedures including but not limited to electrocardiogram (ECG), lab sample collection, spirometry, vital signs, dose verifications, cardiac telemetry monitoring, and questionnaire administration
Assist investigator in verifying that research study objectives are met on time, within budget and according to application protocol requirements, clinical research regulations and quality standards
Assist in providing training to new investigator site staff members on study-specific topics and requirements
Maintain adherence to investigator site staff training requirements by auditing and maintaining training records
Prepare for and as needed attends study monitoring visits, study audits and regulatory inspections with clinical research regulatory agencies
Adhere to standard operating procedures (SOPs) and other directives throughout the process
Assist research site with coverage planning related to staffing and scheduling for research projects
Qualifications
Degree in health care or other scientific discipline preferred
3 years' experience as Site Clinical Research Coordinator as accepted in accordance with local country requirements. Equivalent combination of education, training and experience.
Sound knowledge of clinical trials.
Advanced knowledge of the principals of Good Clinical Practices (GCP).
In-depth knowledge of protocol and study-specific operating procedures, consent forms, and study schedules.
Sound knowledge of medical terminology.
Ability to prioritize, seek input, problem solve and work in a team environment.
Ability to maintain confidentiality.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Applicable certifications and licenses as required by country, state, and/or other regulatory bodies.
Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) strongly preferred.
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 athttps://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 $62,800.00 - $157,100.00. 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.