Clinical Research Site Manager

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 seeking a Site Manager for our South office!

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 Clinical Research Site Mangers will have advance knowledge of ongoing clinical studies including protocols and titration algorithms. This includes but is not limited ensuring proper clinical trial protocol procedures are followed at all times to obtain the correct data, working with providers to schedule patient procedures and sponsor meetings, keeping patient binders organized at all times, and communicating with sponsors with updates on patient data. As Clinical Research Site Manager, this position will act as the primary point-of-contact for research questions/concerns and act as supervisor for research staff at designated location. 

Key duties include but are not limited to:

• Oversees the daily operations of the research department at location while supporting the Director of Site Operations with other location operations on backup basis. Serves as point of contact for research department issues at location. 
• Manages site staff (CRC and ACRCs) including hiring, training, and performance management. 
• Maintains advance knowledge of all ongoing clinical trials in support of CRC and ACRCs. Assists staff with trials and may manage trials as needed. Patient care visits may include but are not limited to drawing blood, collecting vital signs, performing EKG’s, processing specimens, pump/incline training, medication review, and ensuring all procedures are conducted in compliance with the clinical protocol.
• Ensures the processing of any lab work and proper shipment.
• 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.
• Reviews site regulatory documents such as informed consents, Institutional Review Board (IRB) approvals, research agreements to ensure compliance with study requirements.
• Participates in IRB audits.
• Responsible for ensuring completion of all study source documentation for studies at their site, including case report forms and other study specific documents.
• Ensures payments to patients are processed and works with the Finance Director to manage all patient payments.
• Attends / leads provider meetings regarding ongoing and potential clinical trials. Attends/Leads recruitment meetings as applicable and plays a big part in driving the recruitment at their site.
• Interacts with and maintains close communication with the sponsor’s Clinical Research team. Oversees interactions with CRCs and sponsors, including Monitor Visits.
• Partners with providers to coordinate checkup and documents patient updates post visitation.
• Attends sponsor Investigator/Study Coordinator meetings as needed for assigned protocols
• Oversees sponsors’ database clean-up process.
• Keeps after-hours phone in rotation with other Clinical Research Site Managers.
• 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.
• Frequent travel to other locations for coverage, training, and departmental meetings.
• Other duties as assigned.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Qualifications

Education & Experience Requirements:

Minimum Required:

• Minimum 2 years of prior Clinical Trials experience
• Knowledge of research methodology, medical terminology, and pharmacology
• CCRC 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

Additional Information:

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

Frequent travel to all TD&E locations as needed for coverage, trainings and meetings. Reliable transportation is required.

AAP/EEO Statement

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