IQVIA
Job Overview
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 FDA and other regulatory bodies governing the conduct of the study.
Recruits and screens patients for clinical trials and maintains 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 / International Conference on Harmonization.
Schedules and executes study visits and performs 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 reports adverse events and reactions to the 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 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 takes remedial action as required.
Assists and advises 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 implements agreed changes in the study care program.
Assists investigators in verifying that research study objectives are met on time, within budget, and according to application protocol requirements, clinical research regulations, and quality standards.
Provides guidance and supervision to lower‑level site staff to help ensure that processes are carried out in line with protocols and SOPs.
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 toward a high‑performing research study team.
Prepares for and attends 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 and #ONSITE.
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 ensure that processes are carried out in line with protocols and SOPs.
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 toward a high‑performing research study team.
Prepares for and attends 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 and #ONSITE.
Potential base pay range:
$50.00–$60.00 per hour. 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.
Company Overview:
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
Equal Opportunity Employer:
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
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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 FDA and other regulatory bodies governing the conduct of the study.
Recruits and screens patients for clinical trials and maintains 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 / International Conference on Harmonization.
Schedules and executes study visits and performs 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 reports adverse events and reactions to the 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 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 takes remedial action as required.
Assists and advises 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 implements agreed changes in the study care program.
Assists investigators in verifying that research study objectives are met on time, within budget, and according to application protocol requirements, clinical research regulations, and quality standards.
Provides guidance and supervision to lower‑level site staff to help ensure that processes are carried out in line with protocols and SOPs.
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 toward a high‑performing research study team.
Prepares for and attends 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 and #ONSITE.
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 ensure that processes are carried out in line with protocols and SOPs.
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 toward a high‑performing research study team.
Prepares for and attends 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 and #ONSITE.
Potential base pay range:
$50.00–$60.00 per hour. 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.
Company Overview:
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
Equal Opportunity Employer:
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
#J-18808-Ljbffr