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Syneos Health · 1 day ago

Clinical Research Coordinator II - NYC, NY

USA-NY-New York

Full-time

Hybrid

Mid Level

$68K/yr - $115K/yr

Syneos Health is a global organization providing a range of patient-focused clinical services to the pharmaceutical, healthcare, biotechnology, and medical device industries. The Clinical Research Coordinator II will be responsible for coordinating clinical research projects, ensuring compliance with regulatory requirements, and managing multiple clinical trials simultaneously.

BiotechnologyHealth CarePharmaceuticalTherapeutics

Responsibilities

Review of assigned protocols and other protocol documentation (ICF, IB) for accuracy, feasibility, timing, and resources

Prepare and maintain the Investigator Site File and/ or Trial Master File (TMF) for the study

Participate in creation and review of timelines and start-up meetings (Investigator Meeting/SIV, Sponsor discussions, or other related meetings)

Take the lead and/or overall coordination of all required start-up activities including, but not limited, to the following:

Clinic logistics planning, schedule of clinic activities, and team training

Preparation, review, and/or finalization of clinic source documents, time and events tables, and other required study materials; review of Case Report Forms (CRFs), laboratory workbooks, staff requirements, and schedules

In collaboration with the responsible teams, establishes and/or maintains safety assessment requirements, Quality Control (QC) and monitoring plans, pharmacy/dispensing requirements, study supplies/equipment, meal plans, and other elements as applicable to the study

Confirms all required regulatory and contractual documentation is present prior to study start

Support the Principal Investigator as needed with study related tasks such as, but not limited to:

Delegation of Authority Log

Management of daily tasks

Visit calendar development and maintenance

Scheduling and attending monitor visits

Advertise, recruit, and screen potential participants for the study

Perform all study activities following Good Clinical Practices (GCP)

Manage multiple clinical trials simultaneously

Protect the safety of human subjects

Monitor appropriate sources for specific clinical study or federal regulation updates

Collect and enter study data into the appropriate system

Coordinate and monitor screening activities; provides support as required

Assist with informed consent of study subjects

Submit data in required timeframe

Monitor appropriate sources for specific clinical study or federal regulation updates

Complete Case Report Forms

Facilitate audits of study data

Develop patient rapport to explain research protocols and minimize protocol violations

Develop rapport with study team to educate team on study procedures and minimize protocol violations

Respond to inquiries by auditors for data clarification or additional data in required timeframe

Take the lead and/or overall coordination of clinic activities including, but not limited to:

Supervises clinic visits (admission, dosing and randomization, discharge, and follow-up) as required and provides on-call support when applicable

Screens eligibility prior to randomization; oversees, coordinates and/ or performs study drug administration, and other activities as delegated and required

In collaboration with the responsible teams, monitors that all study-related activities are conducted according to protocol, SOP, and applicable regulations

Review and manage clinic updates, Adverse Event (AE) or Serious Adverse Events (SAEs) reporting, study logs and tracker, quality control, and Monitor findings

Coordinate resolution and/or address QC, monitor, CRF, or other internal/external findings

Review and/or oversee close-out of study documentation, deviation reporting, CRF completion and sign-off, and other study-related reports/documentation

Review and update TMF documentation

Finalize study and/or volunteer logs

Ensure completion of other close-out activities as required (return of study supplies, IRB reports, archiving, etc.)

Responsible for monitoring subjects’ compliance throughout the trial and address day-to-day. subject or study issues and escalate as appropriate

Prepare for and participates in sponsor/monitor/QA audits

Provide accurate and timely project status updates to Project Managers and sponsor

Collaborate within and between teams during process improvement exercises, SOP creation. and/or revision, internal and external meetings, and other company-related initiatives and goals

Accommodate flexible schedule (available days, afternoons, nights, and weekends)

Perform other work-related duties as assigned

Maintain proper protocol, consent, amendment, and yearly renewal submission if requested

Report adverse events relating to the trial

Maintain study files

Qualification

Clinical PracticesClinical trial managementRegulatory complianceData entryPatient recruitmentTeam collaborationCommunication skillsProblem-solving

Required

Review of assigned protocols and other protocol documentation (ICF, IB) for accuracy, feasibility, timing, and resources

Prepare and maintain the Investigator Site File and/ or Trial Master File (TMF) for the study

Participate in creation and review of timelines and start-up meetings (Investigator Meeting/SIV, Sponsor discussions, or other related meetings)

Take the lead and/or overall coordination of all required start-up activities including, but not limited, to the following: Clinic logistics planning, schedule of clinic activities, and team training

Confirms all required regulatory and contractual documentation is present prior to study start

Support the Principal Investigator as needed with study related tasks such as, but not limited to: Delegation of Authority Log, Management of daily tasks, Visit calendar development and maintenance, Scheduling and attending monitor visits

Advertise, recruit, and screen potential participants for the study

Perform all study activities following Good Clinical Practices (GCP)

Manage multiple clinical trials simultaneously

Protect the safety of human subjects

Monitor appropriate sources for specific clinical study or federal regulation updates

Collect and enter study data into the appropriate system

Coordinate and monitor screening activities; provides support as required

Assist with informed consent of study subjects

Submit data in required timeframe

Monitor appropriate sources for specific clinical study or federal regulation updates

Complete Case Report Forms

Facilitate audits of study data

Develop patient rapport to explain research protocols and minimize protocol violations

Develop rapport with study team to educate team on study procedures and minimize protocol violations

Respond to inquiries by auditors for data clarification or additional data in required timeframe

Take the lead and/or overall coordination of clinic activities including, but not limited to: Supervises clinic visits (admission, dosing and randomization, discharge, and follow-up) as required and provides on-call support when applicable

Screens eligibility prior to randomization; oversees, coordinates and/ or performs study drug administration, and other activities as delegated and required

In collaboration with the responsible teams, monitors that all study-related activities are conducted according to protocol, SOP, and applicable regulations

Review and manage clinic updates, Adverse Event (AE) or Serious Adverse Events (SAEs) reporting, study logs and tracker, quality control, and Monitor findings

Coordinate resolution and/or address QC, monitor, CRF, or other internal/external findings

Review and/or oversee close-out of study documentation, deviation reporting, CRF completion and sign-off, and other study-related reports/documentation

Review and update TMF documentation

Finalize study and/or volunteer logs

Ensure completion of other close-out activities as required (return of study supplies, IRB reports, archiving, etc.)

Responsible for monitoring subjects' compliance throughout the trial and address day-to-day subject or study issues and escalate as appropriate

Prepare for and participates in sponsor/monitor/QA audits

Provide accurate and timely project status updates to Project Managers and sponsor

Collaborate within and between teams during process improvement exercises, SOP creation. and/or revision, internal and external meetings, and other company-related initiatives and goals

Accommodate flexible schedule (available days, afternoons, nights, and weekends)

Perform other work-related duties as assigned

Maintain proper protocol, consent, amendment, and yearly renewal submission if requested

Report adverse events relating to the trial

Maintain study files

Travel up to 100%