Conduct of Research 

• Assist with oversight of clinical staff including phlebotomist and sleep technician
• Must be comfortable in a clinical setting where blood draws and biopsies occur.
• 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.
• 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/ and 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/ and research manager(s) to manage the day-to-day activities of the study including problem solving, communication and protocol management.
• Preference for candidate with experience administering and scoring cognitive assessments with older adults.
• This position will perform ad hoc assignments as assigned by the Supervisor

Reporting 

• Assists PI/ 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 PI/ and research manager(s) to facilitate the registration of the study at ClinicalTrials.gov and maintains current information on the site (if appropriate).

Supervisory 

• This is a leadership level position, ideal for candidates with an established career in clinical research and expertise in translational and implementation science
• This position supervises and assists with development of learning plans for student research assistants, researcher support staff (i.e. research coordinators I and II) and interns that are assigned to the clinical research projects.
• Act as a resource for research staff in the implementation of clinical research protocols and review of study goals and outcomes, providing guidance informed by your experience and expertise in clinical research topics. 

Project Closeout 

• Collaborates with the lead coordinator(s) to facilitate the submission of accurate and timely closeout documents to applicable Federal agencies, University entities, and the sponsoring agency in accordance with Federal regulations and University and sponsoring agency policies and procedures. 

• Ensures the secure storage of study documents that will be maintained according to University policy or for the contracted length of time, whichever is longer. 

Regulatory and IRB 

• Preparation of revisions to the IRB for submission
• Preparation of continuing reviews to the IRB for submission
• Preparation of all serious adverse events after review with the PI and lead coordinator for submission
• Attendance at all IRB meetings when assigned protocols from the sponsor are scheduled
• 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 ie 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

Other 

• Assist in all other daily activities of research studies
• Other miscellaneous duties as assigned.
• Participate in all required meetings and training sessions as necessary.