Clinical Research Coordinator I

Description

Texas Diabetes & Endocrinology, P.A. (TD&E) has grown over the years to meet the Endocrinology needs of the Austin community. Our mission is to strive to provide expert care in Diabetes, Thyroid problems, Osteoporosis, Weight management and hormonal conditions by providing thorough evaluations and innovative, personalized solutions focused on our patients success. Our employees are the strength that keeps us moving forward.

Our Clinical Research Department is looking for a Clinical Research Coordinator (CRC) I role at our Far West/Central location!

Purpose: The Clinical Research Coordinator (CRC) is a specialized research professional who works closely with and under the guidance of the Principal Investigator (PI) in clinical research. While the PI is primarily responsible for the overall design, conduct, and management of phase II – IV clinical trials, the CRC plays a key role in supporting, coordinating, and facilitating the day-to-day activities of the study. The CRC ensures the study is conducted in compliance with the protocol, relevant regulations, Good Clinical Practice (GCP), and Institutional Review Board (IRB) requirements. In addition to administrative tasks, the CRC may be responsible for serving as a liaison between the clinical site and sponsors, ensuring that the research team is trained according to the protocol, recruiting and/or registering participants, maintaining study protocols, and overseeing data collection and review before it is entered into the study database. Through these activities, the CRC collaborates with the PI, Director of Operations, department, and sponsor to ensure the studies are successful.

Essential Functions:

       Study Coordination:

• Manages complex endocrine-related trials ensuring they adhere to protocols, are ethically conducted, and follow regulatory standards
• Maintains a high level of knowledge and understanding of assigned protocols, including all protocol requirements for patient visits, obtaining informed consent, patient visit schedules, test procedures, laboratory information, and drug accountability requirements
• Liaises with laboratories regarding lab results and/or queries
• Directs the collection, labeling, storage, and transport of all specimens
• Ensures that all equipment and supplies needed for the study are in stock and in good working order
• Attends sponsor Investigator/Study Coordinator meetings as needed for assigned protocols

Participant Management:

• Responsible for screening potential patients including obtaining HIPAA authorization, informed consent for the study, reviewing medical records to determine eligibility, and communicating with the investigator and patient
• Completes and maintains research records of study activity including source documents, case report forms, drug dispensation records, and other regulatory forms as per FDA guidelines
• Ensures proper clinical trial procedures are performed to obtain the correct data, performs medical procedures, and collects data from pump/meters
• Responsible for investigational product (IP) handling, accountability, reconstitution, and destruction
• Understands serious adverse events and adverse event reporting. Reports accurately.
• Communicates with participants regarding study objectives
• Administers questionnaires and monitors participants to ensure adherence to the study’s rules and completion of questionnaires following Good Documentation Practices (GDP)
• Reviews patient diaries and ensures all data is completed following GDP
• Trains patients on how to use pump/incline meter and potential side effects of drugs if applicable
• Provides a safe environment for patients, families, and clinical staff through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC

Regulatory Compliance:

• Follows and adheres to GCP guidelines
• Ensures all regulatory, sponsor communications, and study updates/newsletters are sent to the Regulatory Specialist for filing

       Collaboration & Communication

• Communicates all trial related activities with the PI and all subject complaints or concerns with the PI and Director of Operations
• Monitors and ensures that all trial activities are in compliance with applicable regulatory guidelines, GCP, and organizational standards
• Interacts with and maintains close communication with the sponsor’s Clinical Research Associate
• Works with Data Entry Coordinators to oversee sponsor database clean-up processes
• Assists Clinical Trial Recruiters with recruitment plans for assigned trials
• Maintains up-to-date documentation and reports to support audit readiness
• Collaborates with key staff including Director of Operations, Regulatory Specialist, QA Supervisor, and Data Entry Coordinators

Non-Essential Functions:

• Assists other CRCs with patient visits as needed
• Other duties as assigned

Position Type/Expected Hours of Work:

• Full-time position with working hours between 7:00 am – 5:00 pm and potential weekend work depending on department requirements/manager agreement

Qualifications

Education & Experience Requirements:

Minimum Required:

• Prior experience as a Clinical Research Coordinator or similar role in a medical setting
• CCRC Certification required after qualifying hours met per the ACRP

Preferred:

• At least 2 years of prior experience as a Clinical Research Coordinator or similar role in a medical setting. Experience in Diabetes and/or Endocrine a strong plus.
• Prior experience in a patient care role such as MA, LVN, or RN
• CPR/AED Certification
• CCRC Certification a strong plus

This position will require CCRC certification after meeting all Association of Clinical Research Professional (ACRP) CCRC hours.

AAP/EEO Statement

Texas Diabetes & Endocrinology, P.A. (TDE) provides equal employment opportunities (EEO) to all employees and applicants for employment in accordance with applicable federal, state, and local laws. TDE complies with applicable state and local laws governing nondiscrimination in employment in every location in which it has facilities.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.