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 Site Manager for our Round Rock Office!

Purpose: The Clinical Research Site Manager is responsible for overseeing the daily operations of the Clinical Research Department at their location including the adherence to Standard Operations Procedures, Good Clinical Practice, and FDA regulations. In support of the Clinical Research Coordinators (CRC) and Assistant Clinical Research Coordinators (ACRC), the Site Manager will have advanced knowledge of ongoing clinical studies including protocols and titration algorithms. This includes but is not limited to ensuring proper clinical trial protocol procedures are always followed to obtain the correct data, working with investigators to schedule patient procedures and sponsor meetings, keeping patient charts always organized, and communicating with sponsors with updates on patient data. This person will answer staff questions regarding clinical trials and general office concerns. The Site Manager will work together with the Director of Site Operations on departmental staffing, terminations, performance reviews, and disciplinary actions. This position may manage clinical trials as needed.

Essential Functions:

• Oversees the daily operations of the research department at location while supporting the Director of Site Operations with other location operations on a backup basis.
• Manages and mentors CRCs on day-to-day activities at the site. Handles staffing, performance management, and disciplinary actions with the support of the Director of Site Operations. Ensures staff and direct reports are appropriately trained and supported to enable their success. Approves timesheets and leave requests in Paycom.
• Maintains advanced knowledge of all ongoing clinical trials. Provides oversight and coordination in support of CRC and ACRC, and ensures effective end-to-end planning, execution, and close out of trials.
• Reviews site regulatory documents such as informed consents, Institutional Review Board (IRB) approvals, and research agreements to ensure compliance with study requirements. Participates in IRB audits.
• Oversees interactions with CRCs and sponsors, including Monitor Visits.
• Manages project plans and resources to ensure compliance with protocols and contracts. Maintains an overview of clinical trials’ operational status or risks and proactively communicates the progress and issues to the PI or Sponsor as applicable.
• Serves as the point of contact for research department issues at location. Reports any major issues to the Director of Site Operations and/or Director of Business & Finance and/or Investigators.
• Understands serious adverse events and reporting requirements of clinical trials. Works with the staff to review medical records and ensure all relevant SAE information is reported.
• Interacts with Director of Site Operations and/or Investigators as needed to ensure patient receives appropriate medical evaluation and care when needed. Alerts Director of Site Operations of serious adverse events.
• Is responsible for ensuring completion of all study source documentation for studies at the site, including case report forms and other study specific documents.
• May manage clinical trials as needed, including providing support to CRC:

• • Attends sponsor Investigator/Study Coordinator meetings as needed for assigned protocols. Interacts with and maintains close communication with the sponsor’s Clinical Research team.
  • Coordinates and conducts patient care visits including but not limited to drawing blood, collecting vital signs, performing EKG’s, processing specimens, and ensuring all procedures are conducted in compliance with the clinical protocol. Ensures the processing of any lab work and proper shipment.
  • Partners with providers to coordinate checkup and documents patient updates post visit.
  • Trains patients on how to use pump/incline meter and on potential side effects of medications.
  • Oversees sponsors’ database clean-up process.
• Ensures payments to patients are processed and works with the Director of Business & Finance to manage all patient payments.
• Attends / leads provider meetings regarding ongoing and potential clinical trials.
• Leads research meetings with site staff including creating the agenda.
• Assists the Recruitment Manager with recruitment meetings as applicable and plays a big part in driving the recruitment at their site. Sends regular recruitment updates to site staff and investigators. Is always aware of recruitment needs.
• Keeps after-hours phone as needed. 
• Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

Additional Non-Essential Functions:

• Other duties as assigned.

Qualifications

Education & Experience Requirements:

Minimum Required:

• Minimum 2 years of prior Clinical Trials experience
• Knowledge of research methodology, medical terminology, and pharmacology
• CCRC or CCRP Certification required after qualifying hours met per the ACRP

Preferred:

• Associates/Bachelor’s Degree or equivalent in a scientific heath field/experience
• Prior experience as CRC in a team lead or supervisory capacity
• Experience in Diabetes and/or Endocrine or Pharmaceuticals Clinical Trials
• Prior experience in a patient care role such as MA, LVN, or RN with phlebotomy
• CPR/AED Certification

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