Clinical Research Coordinator - Open Rank

Overview

POSITION-SUMMARY:

Under-the-direction-of-the-Principal-Investigator-(PI)-or-designee,-the-Clinical-Research-Coordinator-is-responsible-for-independently-performing-delegated-tasks-and-procedures-involving-human-subject-research.-This-work-includes-coordination-of-regulatory-activities-and-aspects-of-collection-and-management-of-data-for-research-protocols-related-to-treatment,-ancillary-services,-and-prevention-practices.

This-is-an-open-rank-posting-(there-are-4-levels-of-Clinical-Research-Coordinator)—candidates-will-be-hired-into-the-level-commensurate-with-their-experience.

Responsibilities

ESSENTIAL-FUNCTIONS:

Clinical-Research-Coord-I:

-Obtain-consent-of-research-participants-in-accordance-with-the-IRB-approved-protocols-and-all-applicable-regulations-including-HIPAA

-Identify,-schedule-and/or-conduct-participant-study-visits,-tests-and/or-interviews/telephone-follow-up-calls

-Coordinate-participant-remuneration/compensation-per-protocol

-Maintain-all-regulatory-documentation,-including-local-or-central-IRB-and-study-data.-Provide-data/support-to-study-Investigators,-sponsors-and/or-external-monitors/auditors

-Identify-issues-with-protocol-compliance.-Keep-principal-investigator-and-manager-aware-of-any-issues-regarding-compliance

-Document-and-collect-data-and/or-samples-for-research-related-procedures-performed-during-participant-study-visits.

-Ensure-clinicians-and/or-PI-accurately-document-their-study-activities-according-to-protocol

-Track-and-maintain-study-enrollment-and-completion-of-milestones

-Assist-with-financial-/operational-aspects-of-grant-and-contracts.-May-be-responsible-for-clinical-research-billing-review-within-the-required-timeframe.

-Track-and-maintain-study-related-information-in-the-data-management-system-within-the-required-timeframe

-Responsible-for-monitoring-the-inventory-of-research-related-supplies

-Participate-in-grant-preparation,-manuscript-writing,-data-presentations-and-Institutional-Review-Board-(IRB)-processes

-Provide-detailed-written-summaries-from-literature-searches-and-related-sources-to-serve-as-a-resource-for-the-study-team-and-clinicians/PIs

-Present-study-status-reports-related-to-assigned-research-projects

-Participate-in-the-design,-development,-and-documentation-of-study-related-data-and-collection-tools,-(e.g.-questionnaires,-treatment-data-and/or-therapeutic-checklists)

-Maintain-strict-adherence-to-all-study-protocols,-including-all-regulatory-requirements-adhering-to-appropriate-federal,-local-and-institutional-guidelines.

-Comply-with-all-safety-and-infection-control-standards-appropriate-to-this-position

-Adhere-with-established-policies,-health-and-safety-regulations-and-requirements,-procedures,-and-department-objectives

-Adhere-to-Good-Clinical-Practice-(GCP)-guidelines-and-all-human-subject-protection-practices

-Must-practice-discretion-and-adhere-to-school-and-hospital-confidentiality-at-all-times

-Perform-other-duties-as-required.

Clinical-Research-Coord-II

Duties-noted-above-plus:

-Conduct-preliminary-quality-assurance-reviews-of-study-data

-Contribute-to-data-presentations-and-Institutional-Review-Board-(IRB)-processes

-Track-and-maintain-study-related-information-in-the-data-management-system-within-the-required-timeframe

-Contribute-to-the-design,-development,-and-documentation-of-study-related-data-and-collection-tools,-(e.g.-questionnaires,-treatment-data-and/or-therapeutic-checklists)

-Document-and-collect-data/-samples-for-research-related-procedures-performed-during-participant-study-visits.-Ensure-clinicians-and/or-PI-accurately-document-their-study-activities-according-to-protocol.

-Monitor-strict-adherence-to-all-study-protocols,-including-all-regulatory-requirements-adhering-to-appropriate-federal,-local-and-institutional-guidelines.-Identify-and-resolve-issues-with-protocol-compliance.-Keep-principal-investigator-and-manager-aware-of-any-issues-regarding-compliance

Clinical-Research-Coord-III

Duties-noted-above-plus:

-Assist-with-recruiting,-screening,-selecting,-maintaining-and-terminating-study-subjects-for-multiple-protocols

-Ensure-accuracy-and-completion-of-all-regulatory-documentation,-including-local-or-central-IRB-and-study-data.-Provide-data/support-to-study-Investigators,-sponsors-and/or-external-monitors/auditors

-Direct-the-activities-of-research-support-staff.-Assist-with-the-training-of-staff

-Develop-preliminary-designs-for-study-related-documentation-of-data-and-collection-tools,-(e.g.-questionnaires,-treatment-data-and/or-therapeutic-checklists)

-Contribute-to-grant-preparation,-assessment-of-protocol-feasibility,-manuscript-writing,-data-presentations-and-Institutional-Review-Board-(IRB)-processes

Sr-Clinical-Research-Coord

Duties-noted-above-plus:

-Responsible-for-internal-review/monitoring-of-clinical-data-for-quality-assurance-purposes.-Reports-findings

-Responsible-for-the-smooth-operation-of-all-assigned-studies-on-a-day-to-day-basis,-interacting-with-investigators,-staff-members,-clinicians,-sponsors,-etc.-to-ensure-project-timelines-and-goals-are-met

-Contribute-independently-to-the-development-of-preliminary-designs-for-study-related-documentation-of-data-and-collection-tools,-(e.g.-questionnaires,-treatment-data-and/or-therapeutic-checklists)

-May-Supervise-the-activities-of-research-support-staff.-Assist-with-the-selection,-training,-and-supervision-of-staff

-Prepare-ongoing-summary-reports-from-various-data-sources,-and-collaborate-with-investigators-on-data-presentation,-interpretation,-and-the-writing-of-manuscripts-for-publication-and-grant-proposals

-Identify-and-resolve-issues-with-protocol-compliance.-Keep-principal-investigator-and-manager-aware-of-any-issues-regarding-compliance

-Accountable-for-quality-assurance-reviews-of-study-data

-Assist-with-financial-/operational-aspects-of-grant-and-contracts.-Responsible-for-clinical-research-billing-review-within-the-required-timeframe.

-Contribute-independently-to-grant-preparation,-assessment-of-protocol-feasibility,-manuscript-writing,-data-presentations-and-Institutional-Review-Board-(IRB)-processes

Qualifications

REQUIRED-QUALIFICATIONS:

Clinical-Research-Coord-I:

-Bachelor’s-degree-in-a-scientific-or-health-related-field,-or-equivalent-experience

-0-1-year-of-related-experience

-Ability-to-travel-off-site-locations

-Clinical-Research-Coord-II:

Requirements-noted-for-CRC-I-plus:

-1-3-years-of-related-experience

-Clinical-Research-Coord-III:

Requirements-noted-for-CRC-I-plus:

-3-5-years-of-related-experience

-Sr-Clinical-Research-Coord:

Requirements-noted-for-CRC-I-plus:

-5-7-years-of-related-experience

-Demonstrated-knowledge-of-quality-management-principles-in-a-scientific-or-hospital-setting

Apply Here: www.click2apply.net/MmXjNYCJZOdAqteZxcrVMq

PI226150513