Research Coordinator II, Pediatrics, Full Time, Days
About The Position
Responsible for the implementation, management and oversight of clinical trial research studies including the education of research staff, healthcare team member, participants and their caregivers. Registers, compiles, submits and oversees clinical data, monitors study compliance and maintains a system for effective data flow for patients on clinical trials. Manages patient visits and implements protocol related procedures. Responsible for monitoring and communicating study participant progress and safety issues with the investigators, applicable regulatory agencies, health care team and study staff. Manages study operations by coordinating day today study operations and developing strategies to contribute to the program growth. Monitors study progress and maintains compliance with protocols and regulations. Supports investigator-initiated studies by assisting with protocol development, literature reviews, and creation of data collection tools. Coordinates industry sponsored clinical trials by implementing sponsor provided protocols, completing required regulatory submissions, and ensuring adherence to study procedures and timelines. Assists in coordinating resources to conduct trials including the development of data collection tools and communication with ancillary departments to implement study related procedures. Collaborates with Research Services offices and sponsoring or local agencies to submit required study documents and ensure awareness of study progress, amendments, and regulatory activities.
Requirements
- Bachelor's Degree in Health Sciences or Business-related field of study
- Two (2) years of research experience in at least one of the following areas: pharmaceutical, academic, device, National Institute of Health (NIH), investigator-initiated studies or registry trials
- Equivalent combination of work experience and academic experience may be considered
- BLS is required within six (6) months of employment
- Ability to apply Good Clinical Practice (GCP) principles independently across studies
- Knowledge of clinical research regulations to daily operations
- Ability to apply protocol requirements and troubleshoot visit issues
- Ability to effectively use specialty-specific terminology
- Ability to independently interpret medical records with minimal assistance
- Ability to independently manage quality data abstraction and ensure high-quality source documentation standards
- Ability to maintain ongoing professional development by participating in seminars, workshops, in-service trainings, and by staying current with relevant literature and emerging trends in the field
Nice To Haves
- Collaborative Institutional Training Initiative (CITI) preferred
- If Allied Health Degree: State certification/license in field
- Some team members may be required to have a valid driver’s license to perform the essential functions of the role. In these situations, an acceptable motor vehicle record as defined by the Acceptable Motor Vehicle Record (MVR) Chart, and proof of auto insurance is required.
Responsibilities
- Implementation, management and oversight of clinical trial research studies
- Education of research staff, healthcare team members, participants and their caregivers
- Registering, compiling, submitting and overseeing clinical data
- Monitoring study compliance
- Maintaining a system for effective data flow for patients on clinical trials
- Managing patient visits and implementing protocol related procedures
- Monitoring and communicating study participant progress and safety issues with investigators, regulatory agencies, health care team and study staff
- Coordinating day-to-day study operations
- Developing strategies to contribute to program growth
- Supporting investigator-initiated studies by assisting with protocol development, literature reviews, and creation of data collection tools
- Coordinating industry sponsored clinical trials by implementing sponsor provided protocols, completing required regulatory submissions, and ensuring adherence to study procedures and timelines
- Coordinating resources to conduct trials including the development of data collection tools and communication with ancillary departments to implement study related procedures
- Collaborating with Research Services offices and sponsoring or local agencies to submit required study documents and ensure awareness of study progress, amendments, and regulatory activities
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
