Job Description
- Job Type: Officer of Administration
- Regular/Temporary: Regular
- Hours Per Week: 35
- Salary Range: $64,350.00 to $65,250.00 Annual
The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Position Summary:
This entry-level position provides coordination and administrative support for clinical research projects, specifically in Cardiology, under supervision. Responsibilities include data entry in EDC, Redcap, and CTMS, resolving simple queries, extracting data from medical records for study forms, and maintaining research records such as screening/enrollment logs and electronic regulatory files. Additionally, the role may involve participant recruitment, obtaining consent, device accountability, follow-ups, and monitoring visits under supervision.
Responsibilities
Clinical Coordination - Screen participants for study eligibility and enroll them accurately in various databases.
- Utilize information from EMR, databases, CTMS, and EDC.
- Understand and execute study protocol requirements and procedures.
- Interpret study protocols to ensure compliance.
- Maintain proper documentation as per ICH-GCP guidelines.
- Complete P-card reimbursement for patients.
- Track subject visit billing and invoiceable items.
- Assist in study initiation meetings, audits, and monitoring visits.
- Perform simple study procedures accurately.
- May obtain informed consent from participants.
Data Coordination
- Enter data in CRFs, databases, or EDCs.
- Resolve simple data queries.
- Extract and utilize information from EMR and study databases.
- Complete basic data collection during study visits.
- Document data according to ALCOA-C principles.
- Administer surveys and questionnaires.
- Perform concomitant medication abstraction.
- Build patient research study charts.
- Collect external medical records, CLIAs, CAPs, and radiology CDs as assigned.
Regulatory Coordination
- Maintain documentation following ICH-GCP guidelines.
- Work with regulatory support to collect essential documents and maintain regulatory binders (CVs, MD licenses, lab certifications, IRB rosters, lab norms, etc.).
- Assist the Regulatory Manager in IRB submissions and management.
- Identify and report Adverse Events (AEs), Serious Adverse Events (SAEs), and other safety concerns appropriately.
Administrative Support
- Provide administrative support, including scanning, filing, and organizing research documents.
- Manage research kit organization.
- Communicate with study participants via mail or email.
- Schedule research visits and follow-up appointments.
- Monitor study calendars for procedure completion.
- Manage study supply inventory.
- Track participant recruitment and retention.
- Participate in regular study meetings.
- Process payments and reimbursements for participants.
- Provide logistic and regulatory guidance on Investigator-Initiated Studies to ensure compliance with university and federal guidelines.
- Act as a liaison between investigators, research teams, sponsors, universities, and internal/external departments to resolve issues.
Training
- Complete required training in CITI, GCP, and HIPAA.
- Gain knowledge of EMR, CTMS, EDC, and other relevant databases.
- Learn and apply available technology and systems to job responsibilities.
- Acquire disease-specific knowledge relevant to assigned programs.
- Attend and actively participate in all assigned training.
Competencies
- Functional Knowledge - Understanding of the general research process, medical terminology, and clinical research coordination in a large healthcare setting. Familiarity with university policies and procedures is preferred.
- Problem-Solving - Utilize analytical skills to address simple issues following guidelines and protocols.
- Decision-Making & Autonomy - Work under direct supervision to ensure tasks comply with regulations and study requirements.
- Communication Skills - Effectively share information and confirm data accuracy.
Perform other responsibilities as assigned.
Minimum Qualifications
- Bachelor's degree or equivalent in education, training, and experience.
Preferred Qualifications
- At least two years of related experience
- Knowledge of university policies and procedures
- Basic knowledge and understanding of clinical research processes, regulations, and the role of a Clinical Research Coordinator (CRC)
Other Requirements
- Participation in the medical surveillance program
- Contact with patients and/or human research subjects
- Potential bloodborne pathogen exposure
- Successful completion of applicable compliance and systems training requirements
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Job Tags
Full time, Temporary work, Local area,