Clinical Research Assistant

at  DaVita

17191 St Lukes WaySte 100, The Woodlands, Texas, 77384-8043, United States of America
Job Description
At DaVita Clinical Research, we find that our best leaders are those who create an inspiring vision, have a desire to shape the future of medicine, and empower their team to achieve success. They enjoy tackling difficult problems and believe that the best way to solve them is through a collaborative environment that involves team efforts. They take ownership of results and instill accountability in those they lead. They are driven, compassionate, strong communicators, relationship builders, and find real fulfillment in challenging and impactful work.
We are looking for a highly motivated, positive and innovative Clinical Studies Research Assistant or Sr. level assistant to aid in the coordination, management and conduct of nephrology clinical research trials in dialysis centers and physicians practices. DaVita Clinical Research (DCR) is a Renal Research site network conducting clinical trials across the country. DCR prides itself on a culture of growth, transparency and feedback and would want our leaders to do that same. We want a teammate who is compassionate, purposeful and motivated by meaningful work.
This position is based in our Shenandoah, TX (North Houston) office and coordinate and execute all aspects of late phase clinical trials in the Shenandoah and surrounding North Houston areas.

MINIMUM QUALIFICATIONS:

• Minimum high school diploma or equivalent required
• Minimum two (2) years’ technical degree or higher strongly preferred
• 1 or more years of clinical research experience is strongly preferred OR 2 or more years of clinical research experience is required for a senior level assistant.
• Phlebotomy skills, Medical Assistant or medical background is strongly preferred
• Able to work early morning, evening/night/weekend shifts as necessary to support study schedules.
• Attention to detail and organization skills is required
• Strong Data Entry skills is required
• Basic computer skills and proficiency in Microsoft Word and Outlook
  DaVita Clinical Research (DCR), a wholly owned subsidiary of DaVita Inc., is the research arm of DaVita. DCR innovates through retrospective outcomes research aimed at improving care and quality of life for people with kidney disease. DCR assists pharmaceutical and medical device companies in the design, recruitment and completion of clinical trials using its renal research site network. For 30 years we have helped 500+ clients with their development projects. DCR is based in Minneapolis, MN and operates in locations across the US.

75% - Executes clinical trial procedures and subject care while complying with Good Clinical Practice, regulatory and protocol requirements.

• Communicates subject or trial procedure information to the Operations Supervisor, Charge Nurse, Investigators, Project Managers and Project Coordinators on an ongoing basis to ensure the safety and integrity of subjects and to ensure data collected for trials
• Ensures compliance with Good Clinical Practice (GCP), regulatory, and protocol requirements
• Records study data and maintains source documentation according to Good Documentation Practices.
• Maintains knowledge of research protocols and attends education sessions provided to research staff involved in conducting trial procedures.
• Supports members of study/project teams; reviews source documents, reviews clinical procedures, drafts new procedures or revisions to existing procedures
• Knows, understands, and follows teammate guidelines, employment policies, and department or company procedures.
• Provides consistent, regular, punctual attendance as schedule

75% - Executes clinical trial procedures and subject care while complying with Good Clinical Practice, regulatory and protocol requirements.

• Communicates subject or trial procedure information to the Operations Supervisor, Charge Nurse, Investigators, Project Managers and Project Coordinators on an ongoing basis to ensure the safety and integrity of subjects and to ensure data collected for trials
• Ensures compliance with Good Clinical Practice (GCP), regulatory, and protocol requirements
• Records study data and maintains source documentation according to Good Documentation Practices.
• Maintains knowledge of research protocols and attends education sessions provided to research staff involved in conducting trial procedures.
• Supports members of study/project teams; reviews source documents, reviews clinical procedures, drafts new procedures or revisions to existing procedures
• Knows, understands, and follows teammate guidelines, employment policies, and department or company procedures.
• Provides consistent, regular, punctual attendance as scheduled

10% - Maintains the cleanliness and organization of the clinical research unit.

• Assists with inventory, order and stocking of food, linens and supplies.
• Assists with the equipment maintenance and calibration program as needed.

10% - Provides input for TM performance evaluations and assists with TM orientation and training.
5% - Other duties as assigned.