OPS Research Coordinator

Classification Title:

OPS Research Coordinator

Classification Minimum 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

Job Description:

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.

Expected Salary:

$20 - $25 per hour

Required Qualifications:

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

Preferred:

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

Special Instructions to Applicants:

In order to be considered, you must upload your cover letter and resume.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Health Assessment Required:Yes