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Form of workJob Overview: Part time - 20 hours 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 projec
Job Overview: Part time - 20 hours 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
