Job Description

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 SOP's, 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, d'informations commerciales et de renseignements sur les soins de sante pour les secteurs des sciences de la vie et de la sante. IQVIA se consacre a accelerer le developpement et la commercialisation de traitements medicaux innovants pour aider a ameliorer les resultats des patients et la sante de la population dans le monde entier. Pour en savoir plus, visitez
IQVIA est fiere d'etre un employeur souscrivant au principe de l'egalite d'acces a l'emploi. Tous les candidats qualifies seront pris en consideration pour un emploi sans egard a la race, la couleur, la religion, le sexe, l'orientation sexuelle, l'identite de genre, l'origine nationale, le handicap, l'age, l'etat matrimonial ou tout autre statut protege par la loi applicable. Des mesures d'adaptation pour les candidats handicapes sont disponibles sur demande dans tous les aspects du processus de recrutement. Si vous avez un handicap qui necessite une mesure d'adaptation, nous vous encourageons a contacter notre equipe d'acquisition de talents au workday_recruiting@iqvia.com, afin qu'IQVIA puisse soutenir votre participation au processus de recrutement.
Veuillez noter qu'il est possible que nous utilisions l'intelligence artificielle (IA) dans le traitement de votre candidature. Cependant, nous utilisons l'IA uniquement pour aider notre equipe de recrutement a selectionner ou a evaluer les candidatures, et non pas pour remplacer la prise des decisions par les membres de notre equipe.
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: workday_recruiting@iqvia.com, 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.

Skills Required