assoc clinical Operations leadIQVIA

Job Profile Summary
Coordinate and participate in clinical research studies ensuring that studies are carried out according to protocol, contracted scope of work, good clinical practice, sponsor and Avacare standard operating procedures (SOPs) and any relevant local guidelines and regulations.
Responsibilities
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
Qualifications
Requires 2 - 3 years of prior relevant experience
Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience
Knowledge of clinical trials.
Advanced knowledge of the principals of Good Clinical Practices (GCP).
In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules.
Skill in carrying out required clinical procedures such as spirometry testing or lab sample collection.
Knowledge of medical terminology.
Applicable certifications and licenses as required by country, state, and/or other regulatory bodies. e.g., Registered Nurse (RN).
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at
IQVIA

Pasig City, Metro Manila
Permanent
Full-time