Apply on Employer Site

Inside Higher Ed · 3 days ago

Sr. Research Program Coordinator (DOM-Pulmonary)

Baltimore, MD

Full-time

Onsite

Mid, Senior Level

$41K/yr - $71K/yr

3+ years exp

Johns Hopkins University is seeking a Sr. Research Program Coordinator for the Division of Pulmonary and Critical Care Medicine. The role involves coordinating clinical research studies in ICU settings, managing data collection, and ensuring compliance with regulatory requirements.

Digital MediaEducationHigher EducationJournalismRecruiting

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

Qualification

Clinical research coordinationRegulatory complianceData managementREDCapBudgetingInvoicingCommunicationOrganizational skillsTime managementInterpersonal skills