OPS Research Coordinator

University of Florida•Gainesville, FL

5d•$20 - $25

About The Position

Preparation and/or Review of Scientific Proposal Assists the PI and lead coordinator(s) in reviewing protocol materials for the statewide gastric and gastroesophageal junction (GEJ) cancer study. Reviews study objectives and specific aims to ensure alignment with community-based recruitment and navigation workflows. Performs feasibility assessments, including identifying recruitment venues, community partners, and operational needs for enrolling individuals who have or may suspect GI cancer. Identifies participant-facing resources needed for study participation (flyers, educational materials, event supplies, contact logs, etc.). Collaborates with lead coordinator(s) to prepare a categorized budget and justification reflecting outreach activities, travel to community events, and participant engagement timelines. Regulatory and IRB Reviews and fully comprehends the study protocol, including inclusion/exclusion criteria, recruitment methods, and confidentiality protections. Works with PI and lead coordinator(s) to prepare and submit IRB applications, amendments, continuing reviews, and any ancillary regulatory documents. Prepares study materials (informed consent forms, phone scripts, recruitment scripts, flyer content, community outreach packets, etc.). Ensures the proper setup and organization of regulatory binders, source documentation, consent files, and study-specific logs. Maintains templates and examples of essential documents frequently used for protocol preparation (e.g., consent templates, phone scripts, event sign-in sheets). Conducts quality assurance checks to ensure accurate regulatory binder maintenance, PHI protection, and clean study documentation. Coordinates internal audits, document reviews, and compliance checks as needed. Conduct of Research Supports the day-to-day operational conduct of the study. Maintains familiarity with all aspects of the protocol, including recruitment workflow, screening procedures, study timelines, protected health information requirements, and communication plans. Communicates study requirements to all individuals involved in the study; ensures study team members have appropriate training, tools, and documented training logs. Collects documents needed for study initiation (e.g., CVs, training certificates, delegation logs, FDA 1572 if applicable). Works with PI/lead coordinator(s) to develop and implement recruitment strategies—particularly community-based recruitment of individuals with or suspected of having GI cancer. Attends community events, health fairs, cancer awareness activities, and local outreach opportunities to share study information and connect with potential participants. Conducts or participates in the informed consent process, including discussions with participants, answering questions, securing signatures/dates, and ensuring timely use of amended consent forms. Screens potential participants for eligibility using inclusion/exclusion criteria and documents screening outcomes. Coordinates participant testing, procedures, navigation connections, and follow-up touch points. Collects and records data as required by the protocol; ensures timely completion of case report forms and logs. Maintains study timelines, ensuring outreach, recruitment, and enrollment milestones are met. Monitors and manages adequate inventory of study materials (flyers, event supplies, consent forms, navigation brochures, PPE, etc.). Ensures all study documentation (consent forms, source documents, narrative notes, CRFs, accountability forms) is complete and stored according to protocol, sponsor requirements, and university policy. Maintains ongoing communication with participants, PI, and study staff regarding study progress, scheduled touch points, and participant questions. Assists in the preparation and submission of protocol modifications in accordance with regulatory guidelines. Supports the PI/lead coordinator(s) in managing day-to-day problems, protocol updates, and operational decisions. Reporting Assists the PI and lead coordinator(s) with scientific and compliance reporting requirements per Federal regulations and University policies. Helps facilitate ClinicalTrials.gov registration and maintains updated information as required (if applicable). Supports reporting to stakeholders and partners regarding recruitment progress, community engagement efforts, and participant flow. Project Closeout Works to prepare and submit accurate and timely closeout reports to the University, sponsor, and applicable agencies. Ensures secure long-term storage of study records and materials according to University policy or sponsor requirement, whichever is longer.

Requirements

Associate’s degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience

Nice To Haves

Experience working in healthcare or academic research environments
A customer-service orientation and/or experience working with older adults
Committed to participant protection and privacy

Responsibilities

Assists the PI and lead coordinator(s) in reviewing protocol materials for the statewide gastric and gastroesophageal junction (GEJ) cancer study.
Reviews study objectives and specific aims to ensure alignment with community-based recruitment and navigation workflows.
Performs feasibility assessments, including identifying recruitment venues, community partners, and operational needs for enrolling individuals who have or may suspect GI cancer.
Identifies participant-facing resources needed for study participation (flyers, educational materials, event supplies, contact logs, etc.).
Collaborates with lead coordinator(s) to prepare a categorized budget and justification reflecting outreach activities, travel to community events, and participant engagement timelines.
Works with PI and lead coordinator(s) to prepare and submit IRB applications, amendments, continuing reviews, and any ancillary regulatory documents.
Prepares study materials (informed consent forms, phone scripts, recruitment scripts, flyer content, community outreach packets, etc.).
Ensures the proper setup and organization of regulatory binders, source documentation, consent files, and study-specific logs.
Maintains templates and examples of essential documents frequently used for protocol preparation (e.g., consent templates, phone scripts, event sign-in sheets).
Conducts quality assurance checks to ensure accurate regulatory binder maintenance, PHI protection, and clean study documentation.
Coordinates internal audits, document reviews, and compliance checks as needed.
Supports the day-to-day operational conduct of the study.
Maintains familiarity with all aspects of the protocol, including recruitment workflow, screening procedures, study timelines, protected health information requirements, and communication plans.
Communicates study requirements to all individuals involved in the study; ensures study team members have appropriate training, tools, and documented training logs.
Collects documents needed for study initiation (e.g., CVs, training certificates, delegation logs, FDA 1572 if applicable).
Works with PI/lead coordinator(s) to develop and implement recruitment strategies—particularly community-based recruitment of individuals with or suspected of having GI cancer.
Attends community events, health fairs, cancer awareness activities, and local outreach opportunities to share study information and connect with potential participants.
Conducts or participates in the informed consent process, including discussions with participants, answering questions, securing signatures/dates, and ensuring timely use of amended consent forms.
Screens potential participants for eligibility using inclusion/exclusion criteria and documents screening outcomes.
Coordinates participant testing, procedures, navigation connections, and follow-up touch points.
Collects and records data as required by the protocol; ensures timely completion of case report forms and logs.
Maintains study timelines, ensuring outreach, recruitment, and enrollment milestones are met.
Monitors and manages adequate inventory of study materials (flyers, event supplies, consent forms, navigation brochures, PPE, etc.).
Ensures all study documentation (consent forms, source documents, narrative notes, CRFs, accountability forms) is complete and stored according to protocol, sponsor requirements, and university policy.
Maintains ongoing communication with participants, PI, and study staff regarding study progress, scheduled touch points, and participant questions.
Assists in the preparation and submission of protocol modifications in accordance with regulatory guidelines.
Supports the PI/lead coordinator(s) in managing day-to-day problems, protocol updates, and operational decisions.
Assists the PI and lead coordinator(s) with scientific and compliance reporting requirements per Federal regulations and University policies.
Helps facilitate ClinicalTrials.gov registration and maintains updated information as required (if applicable).
Supports reporting to stakeholders and partners regarding recruitment progress, community engagement efforts, and participant flow.
Works to prepare and submit accurate and timely closeout reports to the University, sponsor, and applicable agencies.
Ensures secure long-term storage of study records and materials according to University policy or sponsor requirement, whichever is longer.