Job Description
The top qualifications for success in this role include hands-on experience coordinating clinical research involving human subjects, including familiarity with IRB processes, informed consent, and direct or virtual patient engagement. Additionally, applicants should bring strong data analysis and management skills, ideally with experience working with clinical or digital health data, statistical software (e.g., R, Stata, SAS), and tools like REDCap.
This is an exciting opportunity for medical students to contribute to innovative research at the intersection of digital health and cancer survivorship. Participants will gain meaningful experience through patient interaction, data-driven research, and collaborative scholarly activities-with opportunities to support abstract submissions, manuscripts, and interdisciplinary projects that advance the field.
The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time. Primary Duties and Responsibilities
- Independent study coordination including screening of potential patients for protocol eligibility, presenting
- non-medical trial concepts and details to the patients, and participating in the informed consent process.
- Schedules patients for research visits and procedures.
- In collaboration with the physician and other medical personnel, documents thoroughly on Case Report
- Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
- Maintains accurate source documents related to all research procedures.
- Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
- Schedules and participates in monitoring and auditing activities.
- Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
- Notifies direct supervisor about concerns regarding data quality and study conduct.
- Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit
- Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
- May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
- Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
- May coordinate training and education of other personnel.
- May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
- May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.
Qualifications Job qualifications The top qualifications for success in this role include hands-on experience coordinating clinical research involving human subjects, including familiarity with IRB processes, informed consent, and direct or virtual patient engagement. Additionally, applicants should bring strong data analysis and management skills, ideally with experience working with clinical or digital health data, statistical software (e.g., R, Stata, SAS), and tools like REDCap.
- High School Diploma/GED required.
- 2 years Clinical research related experience required.
Preferred:
- Bachelor's Degree Science, Sociology or related degree.
Job Tags
Full time, Local area,