Clinical Research Coordinator I for Health Policy and Economics
About The Position
The Neonatology Health Services Research group studies how health systems and policies influences the health and epidemiology of birthing parents and their infants. We are seeking a full-time Clinical Research Coordinator (CRC) to help with our health policy and hospital financing studies. This individual will work closely with a team of principal investigators, post docs, statisticians, and research coordinators. The CRC will perform in depth review of policies and assist with dataset creation regarding hospital ownership and finances, prepare and update study IRB paperwork, and develop familiarity with econometric methods. Prior experience with health policy analyses and statistical coding (Stata, R) is a plus. Successful applicants will be self-driven learners, detail-oriented, clear communication, and problem-solving skills. The ideal candidate will have coursework background in public policy, economics, and statistics, as well as an interest in health policy.
Requirements
- High School Diploma / GED Required
- At least two (2) years of clinical or research related experience Required
- Basic knowledge of IRB and human subject protection
- Strong verbal and written communications skills
- Strong time management skills
- Ability to collaborate with stakeholders at all levels
Nice To Haves
- Bachelor's Degree Preferred
- At least three (3) years of clinical or research related experience Preferred
- Prior experience with health policy analyses and statistical coding (Stata, R) is a plus
- Coursework background in public policy, economics, and statistics, as well as an interest in health policy
Responsibilities
- Adhere to an IRB approved protocol
- Participate in the informed consent process of study subjects
- Support the safety of clinical research patients/research participants
- Coordinate protocol related research procedures, study visits, and follow-up care
- Screen, recruit and enroll patients/research participants
- Maintain study source documents
- Under the supervision of PI Report adverse events
- Understand good clinical practice (GCP) and regulatory compliance
- Educate subjects and family on protocol, study intervention, etc.
- Comply with Institutional policies, standard operating procedures (SOPs) and guidelines, and with HIPAA and management of confidential materials
- Must comply with federal, state, and sponsor policies
- For multi-site studies or collaborations, support communication and meeting scheduling across teams
- Manage essential regulatory documents
- Register study on ClinicalTrials.gov as appropriate
- Complete case report forms (paper & electronic data capture) and address queries
- Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie,DSMB, independent safety officer)
- Facilitate pre-study, site qualification, study initiation, and monitoring visit as appropriate
- Facilitate study close out activities as appropriate
- Coordinate research/project team meetings
- Collect, process and ship samples as applicable to the protocol
- Schedule subject visits and procedures
- Retain records/archive documents after study close out
Benefits
- Annual influenza vaccine
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
5,001-10,000 employees
