Job Details

Clinical Research Coordinator

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

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.

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.

The potential base pay range for this role is $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.