Sr. Research Program Coordinator

We are seeking a Sr. Research Program Coordinator who will coordinate multi- and single-center, federally- and industry-funded clinical research studies conducted in the ICU and post-ICU settings for the Division of Pulmonary and Critical Care Medicine. The coordinator will perform, train and/or supervise duties, including consenting, collecting and entering clinical data, and carrying out related research duties for new and ongoing studies based in the ICU. The coordinator will prepare project progress reports, conduct literature searches, assist with manuscript preparation, and provide support for grant applications.

Specific Duties & Responsibilities

• Maintain detailed working knowledge of assigned protocols; design and compile materials which aid investigators and other research staff in complying with protocol requirements.
• Prepare initial protocol submissions, develop consent forms and other regulatory documents in compliance with federal, university, departmental and other regulations

• Serve as the primary point of contact and liaison between PI, research staff, budget office, Office of Research Administration, and other administrative/regulatory areas.
• Coordinate flow of communication between all entities involved in research projects.
• Manage administrative workflow to streamline the execution of contracts/subcontracts and protocol approval processes.
• Participate in study initiation meetings.

• Maintain regulatory binders/spreadsheets for assigned protocols.

• Oversee and conduct recruitment, screening, and enrolling of eligible patients into assigned protocols.
• Verifies patient eligibility for studies. Identifies study participants and is involved in their recruitment process on various clinical trials.

• Obtain informed consent from participants or their legally authorized representatives, explain assigned protocols in detail and conduct informed consent procedures according to required process and protocol eligibility criteria.

• Abstract patient clinical and demographic data from a variety of sources (including paper and electronic medical records multiple electronic platforms) and enter into a CRF, tracking spreadsheet or database.

• Administer standardized surveys to research subjects or their proxies via phone, or via in- patient, clinic or home visits.

• Communicate and collaborate with the PI, treating physician, study coordinators and other members of the study team on an ongoing basis regarding the implementation of the protocol and status of subjects.

• Coordinate investigator meetings, data management meetings, meetings with study investigators and study sub-sites.

• Perform data management and analyses, including advanced use of spreadsheets and databases for studies.

• Ensure accuracy and timeliness of data collection entry, management and analyses.

• Monitor compliance with data quality assurance and quality control goals of clinical studies and follow all written and unwritten study practices, procedures and protocols.

• Prepare and submit changes in research, annual renewals, amendments, and adverse event reports to IRB, DSMB, and sponsor (as applicable).
• Assist in the preparation of IRB, DSMB, and sponsor reports.
• Provide timely data and prompt notification of SAEs, protocol deviations, treatment delays and end of treatment visits.
• Coordinate serious adverse event reporting with the investigators to ensure prompt reporting to the IRB, DSMB, and study sponsor
• Review protocol amendments to identify changes to treatment orders, study calendar and risks to subjects. Lists and clarifies concerns & questions about new protocols with PI and/or sponsor.
• Prepare for and participates in monitoring and audits of studies. Corrects errors in database when necessary. Write responses to audit reports with input from the Principal Investigator.
• Maintain compliance with HIPAA and IRB regulations and guidelines.
• Assist in supervising multiple research staff involved in research activities.
• Prepare weekly reports of activities for supervisor.

Additional Knowledge, Skills, and Abilities

• Excellent oral and written communication skills.
• Ability to work independently and manage multiple tasks, detail oriented, self-motivated, strong interpersonal skills.
• Excellent organizational and time-management skills.
• Ability to use personal computer, proficiency in Microsoft Word and Excel and database software (e.g. REDCap, ACCESS).
• Able to effectively prioritize and work on multiple tasks with concurrent deadlines and demonstrate excellent time management skills and efficiency.