Essential Functions
- Oversee, assess and ensure participant safety and strict protocol implementation/adherence; oversee compliance with GCP guidelines, federal regulations, institutional policies and procedures, and internal SOPs.
- Assists in development of study budgets; monitors budget expenses for allied services; maintains all billing, incentive, and reimbursement records.
- Disseminates information about the protocol auxiliary personnel.
- Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinates and performs responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits and acting as a liaison between participants and study-related parties.
- Analyze study monitoring and operational reports to monitor production and data collection events; evaluate progress towards meeting required timelines and data collection tasks.
- Works with the Data Coordinating Center to monitor participant progression throughout study and conducts evaluation at pre-specified intervals and at end of study.
- Creates and maintains a system to track data entry and audit for completeness, accuracy, and timeliness of data collection.
- Recognizes, tracks and reports adverse events and protocol deviations.
- Prepares for and coordinates site visits made by sponsors or federal agencies during the course of and at the close of the study.
- Implement procedures to prevent future events, including staff education and retraining
- Prepares, submits and maintains IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence.
- Develops and maintains patient databases, investigational logs and records of drugs administered and/or procedures followed.
- Completes ongoing training on techniques of clinical research coordination and practices, FDA Good Clinical Practices (GCP), and clinical research standard operating procedures to ensure compliance with policy and procedure, research sponsors and Federal rules and regulations.
- Assures proper laboratory samples are collected and shipped per study protocol and results are reported to the proper entities.
- Coordinates with physicians to provide information regarding available research projects and to maintain a strong referral basis.
- Assists the Principal Investigator in the development of study materials and protocols.
- Represent the research program at meetings, national and international research consortia as determined by the Principal Investigator and Pediatric Heart Center Administrative Research Director.
- Organizes the activities within the assigned grant proposals under the direction of the Principal Investigator.
- Plays a central role in assuring participant safety, ongoing maintenance of informed consent, integrity of protocol implementation accuracy of data collection, data recording and follow up.
- Provides care received to research participants driven by study requirements and the collection of research data as well as clinical indications. Study procedures may include administration of investigational drugs and monitoring of side effects, performance of an experimental or investigational surgical or radiological procedure, detailed clinical assessment, for example.
Comments
Work Environment and Level of Frequency that may be required:
Nearly Continuously: Office environment.
Seldom: Infectious disease, oils (there is air or skin exposure to oils or other cutting fluids).
Physical Requirements and Level of Frequency that may be required
Nearly Continuously: Hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking, standing, sitting.
Seldom: Bending, reaching overhead.
The staff member must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her assigned unit. The individual must demonstrate knowledge of the principles of life span growth and development and the ability to assess data regarding the patient’s status and provide care as described in the department’s policies and procedures manual.
Disclaimer
This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.