Position Summary
The Research Coordinator will provide operational, regulatory, and data management support for a VA CSR&D-funded study evaluating mid-term outcomes of restrictive versus liberal postoperative transfusion strategies in high cardiac risk veterans. The coordinator will be responsible for participant follow-up, data abstraction from electronic medical records, collection of mid-term outcomes, and maintenance of a secure study database for extended (1-, 3-, and 5-year) follow-up. They may also help address additional research questions.
Major Duties and Responsibilities
- Participant Identification and Eligibility
- Verify TOP trial participants for eligibility for extended follow‑up using protocol-defined inclusion and exclusion criteria, prior to data entry.
- Data Abstraction and Medical Record Review
- Abstract definition-adherent clinical data from the electronic medical record (EMR), including perioperative characteristics, renal function metrics, limb status, and mortality data, in accordance with the study protocol and data dictionary.
- Identify and capture relevant laboratory values, imaging reports, procedure notes, and clinic documentation needed to assess chronic kidney disease progression, chronic limb-threatening ischemia, major amputations, and survival outcomes at 1, 3, and 5 years.
- Ensure data completeness and accuracy through routine data quality checks and query resolution with the investigative team.
- Participant Contact and Records Retrieval
- Contact participants and/or appropriate proxies to confirm vital status, health events, and care received outside the VA system, using IRB-approved communication scripts.
- Obtain and process medical record release forms for non-VA care, coordinating with external institutions to secure necessary documentation.
- Document all contact attempts and outcomes in tracking systems, ensuring timely and respectful communication with veterans and their families.
- Data Entry and Database Management
- Support development of data entry system.
- Enter abstracted data into a secure, study-specific database in a timely and accurate manner, following established data standards and coding conventions.
- Perform routine data validation, discrepancy checks, and reconciliation between source documents and database entries.
- Assist with preparation of analytic datasets and data exports for the study statisticians.
- Regulatory Compliance and Study Administration
- Prepare, submit, and maintain of IRB and VA Research & Development (R&D) approvals, amendments, continuing reviews, and reportable events.
- Maintain regulatory binders and essential documents in compliance with VA, institutional, and federal requirements.
- Assist in developing and updating standard operating procedures (SOPs), manuals of procedures, and training materials related to study conduct, data abstraction, and participant follow‑up.
- Coordinate study meetings, prepare agendas and minutes, and support communication among investigators, statisticians, and collaborating sites.
6. Quality Improvement and Reporting
- Contribute to monitoring of study progress, including enrollment/follow-up metrics, data completeness, and timelines for 1-, 3-, and 5-year outcome capture.
- Assist with preparation of interim reports, presentations, and manuscripts by providing updated datasets, tables, and descriptive summaries as requested by the principal investigator.
Knowledge, Skills, and Abilities
- Knowledge of clinical research principles, including randomized controlled trials, observational follow‑up, and confounding by indication, or willingness to acquire this knowledge through on‑the‑job training.
- Strong skills in medical record review and clinical data abstraction, with attention to detail and adherence to protocol definitions.
- Familiarity with postoperative care, cardiovascular disease, chronic kidney disease, peripheral arterial disease, and related terminology preferred.
- Ability to work with electronic medical records and secure research databases; experience with spreadsheet and database software (e.g., Excel, REDCap, or similar) preferred.
- Understanding of human subjects protections, privacy and confidentiality requirements, and regulatory processes (IRB, VA R&D).
- Excellent organizational skills, with the ability to manage multiple tasks, timelines, and follow‑up intervals (1-, 3-, and 5-year outcomes).
- Strong written and verbal communication skills for interacting with veterans, families, clinical staff, and research team members.
- Ability to work both independently and as part of a multidisciplinary team.
Qualifications
- Master’s degree in a health-related field (e.g., nursing, public health, biology, psychology) or equivalent experience in clinical research.
- Prior experience as a research coordinator, clinical research assistant, or similar role preferred.
- Experience with statistical software and biostatistics preferred
- Experience working in VA or other large health system environments desirable.
- Certification in clinical research (e.g., ACRP, SOCRA) is desirable but not required.
Work Conditions
- Primarily office-based work within a clinical research setting, with extensive use of computers for EMR review and data entry.
- Patient or family contact by phone, per protocols.
- May require completion of VA-specific training and credentialing requirements.
Pay: From $65,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- Vision insurance
Work Location: In person