OPS Clinical Research Coordinator

Classification Title:

OPS Sponsored Project Non-Clerical

Job Description:

The Research Coordinator will have various responsibilities related to: Preparation and/or Review of the Scientific Proposal, Regulatory and IRB Protocols, Conduct of Research, Reporting, and Project Closeout procedures.

 

Preparation and/or Review of Scientific Proposal

• Assists the PI and research managers(s) in reviewing protocols
• Review of specific aims
• Perform study feasibility assessments
• Identify resources needed for participants
• Collaborates with the research manager(s) to prepare a categorized budget and justification.

 

Regulatory and IRB

• Reviews and comprehends the protocol.
• Collaborates with the PI and research manager(s) to prepare IRB and any other regulatory submission documents as required by the protocol. 
• Prepares other study materials as requested by the PI/ research manager(s). These study materials include, but are not limited to, the informed consent document
• Ensures proper organization of study files, including but not limited to, regulatory binders, study specific source documentation and other materials by the research coordinator assigned to the investigation
• Maintenance of templates and examples of essential documents frequently used in the preparation of a protocol i.e. informed consent, telephone script
• Performs quality assurance ensuring proper maintenance of regulatory binder, protected health information and study documents
• Coordinates internal audits as deemed appropriate

 

Conduct of Research

• Supports clinical conduct of research and perform these duties as needed. 
• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
• Communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
• Collects documents needed to initiate the study for submission to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
• Works with the PI/ research manager(s) to develop and implement recruitment strategies in accordance with IRB requirements and approvals.
• Conducts or participates in the informed consent process including interactions with the IRB, discussions with research participants, including answering any questions related to the protocol. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
• Coordinates participant tests and procedures.
• Collects data as required by the protocol. Assures timely completion of Case Report Forms.
• Maintains study timelines.
• Maintains adequate inventory of study supplies including Investigational Drug/Device Accountability.
• Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms, etc.
• Retains all study records in accordance with sponsor requirements and University policies and procedures.
• Maintains effective and ongoing communication with research participants, lead coordinator(s) and PI during the course of the study.
• Assists PI/ research manager(s) in preparation and submission of any modifications to the scientific protocol in accordance with Federal regulations and University and sponsoring agency policies and procedures.
• Works with the PI/lead coordinator(s) to manage the day-to-day activities of the study including problem solving, communication and protocol management.

 

Reporting

• Assists Principal Investigator and research manager(s) with scientific and compliance reporting requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures.
• Assists the research manager(s) and Principal Investigator to facilitate the registration of the study at ClinicalTrials.gov and maintains current information on the site (if appropriate).

 

Project Closeout

• Collaborates with the research manager(s) to facilitate th