Austin Heart is growing and seeking a motivated and experienced Clinical Research Coordinator for our new Marble Falls, Texas site. This position will likely require travel to Harker Heights, Texas and occasionally, Austin, Texas.
We offer an excellent benefits package, competitive salary and growth opportunities. Join our team at Austin Heart- Marble Falls and share your skills and talents with the nation's largest private provider of healthcare services.
The primary responsibilities of the Clinical Research Coordinator is to direct, plan, and coordinate the operations of assigned clinical research studies from pre-study planning through study closeout, including successful completion of all patient visits and related documentation.
DUTIES INCLUDE BUT NOT LIMITED TO:
Coordinate research-related activities with clinical and non-clinical staff throughout the health system.
Assist in ensuring that all new employees are oriented to the program.
Provide education, orientation and in-services for the program staff when deficits in clinical knowledge are identified.
Provide supervision and direction to any clinical trials assistants or other delegates of the Principal Investigator.
Coordinates and manages clinical studies according to OHRP and FDA regulations, as well as, ICH Good Clinical Practices and IRB requirements.
Promote organization to private industry or governmental sponsors of clinical trials.
Assists in preparing study contracts and budgets.
Obtain detailed knowledge of all components of study protocol through independent analysis and review of study to complete all study activities completely.
Attend mandatory educational programs (i.e. Investigator Meetings) which may include traveling to different cities.
Complete all paperwork affiliated with the study, including but not limited to the requirements of the facility, the IRB and the study Sponsor.
Use time constructively and in an organized manner to accomplish assigned responsibilities.
Screen patients and/or their medical records and identify potential subjects for a specific study on a timely basis and within the recruitment period.
Ensure that all subjects meet protocol requirements by utilizing inclusion/exclusion criteria.
Ensure that an original copy of any subjects Informed Consent Document is in the research binders, as well as, a copy on the subject’s medical record.
Schedule all subject visits and procedures to meet protocol requirements. Provide instructions and pertinent dates to ensure proper protocol compliance.
Ensure that all protocol activities are performed by approved research staff.
Ensure that all laboratory samples are collected and processed properly and a timely basis.
If adequately licensed, distribute study medications and perform medical procedures according to the protocol requirements.
Report to the IRB and any research sponsors any and all adverse events experience by he subject.
Server as a liaison between the subject and their care giver.
Serve as the primary contact with the research sponsor.
Serves as the internal expert regarding all study protocols.
Serves as the internal expert on clinical research regulatory matters.
KNOWLEDGE, SKILLS AND ABILITIES: This position requires the following minimum requirements:
Knowledge of cardiovascular and medical nursing procedures is preferred.
Knowledge of regulatory guidelines regarding research (e.g. “Common Rule”, “GCP” etc.)
Knowledgeable on medical coding and billing procedures in a physician practice setting.
Ability to evaluate the effectiveness of existing methods and procedures.
Ability to communicate effectively with patients, clinical and administrative staff and the public.
Ability to interpret, adapt and apply guidelines and policies and procedures.
Skill in dealing with interpersonal issues and customer relations.
Ability to handle multiple priorities at once with minimal supervision.
Ability to plan, organize, delegate and supervise.
The HCA Physician Services Group (PSG) is the physician solution for the Hospital Corporation of America. PSG makes it easier for physicians to practice medicine by reducing the burdens of managing an independent practice and infusing the best clinical and operational standards in every office. With 13,000 employees that work in more than 790 practices across 21 states, PSG is leading the way by delivering high quality, cost effective health care in communities across the country.
RN preferred but not required
CCRC preferred but not required
CCRP preferred but not required
At least 2 years of experience as a Certified Clinical Research Coordinator, or eligible to test for certification
Experience and knowledge of IRB submissions, FDA regulations, data collections, and exposure to EMR systems.
About Austin Heart (St. David's Heart and Vascular)
Setting the Standard in Cardiac & Vascular Care
Austin Heart has been providing superior, patient-centered cardiac and vascular care since 1994. As the largest provider of cardiac and vascular services in Central Texas, with 12 full-time office locations and 19 outreach clinics. From San Marcos to Harker Heights, and La Grange to Fredericksburg, Austin Heart provides exceptional, compassionate ...care to our patients.
Austin Heart is part of the HCA family and is affiliated with St. David’s HealthCare, one of four organizations in the nation that was recently awarded the prestigious 2014 Malcolm Baldrige National Quality Award for performance excellence.
Austin Heart and Heart Hospital of Austin
Austin Heart physicians founded the Heart Hospital of Austin in 1998. Austin Heart is a separate organization of 45 cardiologists in a group practice. The Heart Hospital of Austin and the group practice, Austin Heart, became part of the St. David’s partnership in 2010. By focusing only on cardiovascular disease, the Heart Hospital of Austin achieves better outcomes and provides advanced treatment options in a patient-centered environment. In 2010, the Heart Hospital of Austin was rated the No. 1 hospital in the state of Texas for overall cardiology services by HealthGrades, the nation’s leading independent provider of hospital ratings.
Hospital Corporation of America
One of the nation’s leading providers of healthcare services, HCA is made up of locally managed facilities that include more than 250 hospitals and freestanding surgery centers located in 20 U.S. states and in the United Kingdom.