Job Overview: Part time - 24 hours/wk and onsite support.
Coordinate and participate in clinical research studies ensuring that studies are carried out according to
protocol contracted scope of work good clinical practice sponsor standard operating
procedures (SOPs) and any relevant local guidelines and regulations.
Essential Functions
Provides clinical research support to investigators to prepare for and execute assigned research studies
Reviews study protocols source document forms other study-specific documents and electronic data
capture systems used to record clinical research data
Collects and submits regulatory/ethics documentation as required by the Federal Drug Administration
(FDA) and other regulatory bodies governing the conduct of the study
Recruits and screens patients for clinical trials and maintain subject screening and enrollment logs
Orients research subjects to the study including the purpose of the study procedures and protocol
requirements such as timeline for visits
Maintains source documentation based on protocol requirements that adhere to Good Clinical Practice
(GCP)/International Conference on Harmonization (ICH) documentation principles
Schedules and executes study visits and perform study procedures as delegated and supervised by the
Principal Investigator
Handles lab testing and analysis including preparation of specimen collection tubes and lab logistics
Monitors subject safety and report adverse events and reactions to Principal Investigator study team
members and IRBs as appropriate
Corresponds with research subjects to troubleshoot study-related questions or concerns
Participates 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
Performs 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
Updates and maintains site staff skills training and knowledge of current best nursing practices and topics
related to clinical research
Assists the investigators to safeguard the well-being of subjects and maintain standards required of
clinical research sites
Maintains a safe environment in accordance with site policies
Acts as an advocate for research subjects
Addresses subject questions in a pro-active manner and take remedial action as required
Assists and advise site staff in nursing practices and on the delivery of study care to subjects
Reports any deviations from normal research practices to senior staff and implement agreed changes in
the study care program
Assists 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
Assists in providing training to new investigator site staff members on study-specific topics and
requirements
Maintains adherence to investigator site staff training requirements by auditing and maintaining training
records
Provides guidance and supervision to lower level site staff to help provide that processes are carried out
in line with protocols and SOPs where applicable
Participates in study process reviews and enhancement efforts to support control of site unit budget
development of the research facilities and site services and the culture towards a high performing research
study team
Prepares for and attend study monitoring visits study audits and regulatory inspections with clinical
research regulatory agencies
Adheres to standard operating procedures (SOPs) and other directives throughout this process
Assists research site with coverage planning related to staffing and scheduling for research projects
#LI-CES and #LI-DNP #LI-HCP #ONSITE
IQVIA est un fournisseur mondial de premier plan de services de recherche clinique dinformations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé. IQVIA se consacre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus visitez
IQVIA est fière dêtre un employeur souscrivant au principe de légalité daccès à lemploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race la couleur la religion le sexe lorientation sexuelle lidentité de genre lorigine nationale le handicap lâge létat matrimonial ou tout autre statut protégé par la loi applicable. Des mesures dadaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement. Si vous avez un handicap qui nécessite une mesure dadaptation nous vous encourageons à contacter notre équipe dacquisition de talents au afin quIQVIA puisse soutenir votre participation au processus de recrutement.
Veuillez noter quil est possible que nous utilisions lintelligence artificielle (IA) dans le traitement de votre candidature. Cependant nous utilisons lIA uniquement pour aider notre équipe de recrutement à sélectionner ou à évaluer les candidatures et non pas pour remplacer la prise des décisions par les membres de notre équipe.
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
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 age marital status or any other status protected by applicable law. Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request. If you have a disability that requires an accommodation we encourage you to contact our Talent Acquisition Team at: so that IQVIA can support your participation in the recruitment process.
Please note that we may use artificial intelligence (AI) in the processing of your application. However we only use AI to assist our recruitment team with the screening or assessment of candidacies and not as a substitute for human decision-making.
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more