Senior Clinical Research Coordinator

Digestive Health Associates of Texas, P.A. - Richardson, TX

Full-timeEstimated: $57,000 - $81,000 a year
EducationSkillsBenefits
About the Company:
Digestive Health Associates of Texas, P.A. (DHAT), is a large Gastroenterology group consisting of over 80 physicians with over 40 locations throughout the Dallas/Ft Worth area. We provide cost-effective, community-based health care services supporting the full spectrum of an individual’s digestive healthcare, with access and quality patient care unsurpassed in this area.

We are an equal opportunity employer committed to ensuring a diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. To view the most recent EEO is the Law and e-Verify Posters, click here.

COMPENSATION & BENEFITS:
Digestive Health Management is an Equal Employment Opportunity employer. We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive compensation package and future growth opportunities within the company. For full-time employees, we offer an extensive benefits package including medical, dental, vision benefits, basic and optional life insurance, short and long term disability, flexible spending accounts, health savings account, 401(k) with company match and discretionary profit sharing, paid holidays, vacation, sick time, a competitive salary and an enjoyable work environment.

ABOUT THIS POSITION:
The Senior Certified Clinical Research Coordinator (SCCRC) will perform high-level clinical trial management, working collaboratively with a multi-disciplinary team of research professionals, healthcare providers, pharmaceutical sponsors and other third parties. This SCCRC will have oversight and responsibility for managing the daily operations of multiple sponsored clinical trials (Phases I through IV), for all indications within gastroenterology, for both adult and pediatric patients. The SCCRC will also provide guidance and training to the research team, and have oversight duties as delegated by the clinical and administrative leadership of DHAT Research Institute.

PRIMARY JOB DUTIES:
The Essential Job Functions related to Clinical Research:
Maintains a detailed knowledge of study protocol(s) in-order-to complete all study activities accurately and completely
Maintains an ongoing understanding of the indications under investigation
Recruits, screens, and retains patients for clinical trials
Performs comprehensive medical history and data reviews to ensure proper enrollment and randomization of qualified subjects per the inclusion / exclusion criteria
Provides instructions and education to subjects to ensure proper protocol compliance
Ensures that all laboratory samples are collected, prepared and shipped properly; tests are performed at the designated lab facility accurately and on a timely basis
Distributes study test articles per the protocol requirements and Investigator instructions and maintain complete and accurate test article accountability records
Updates the Investigator of all patient progress, adverse events, non-compliance, and safety issues throughout the duration of the clinical trial
Reports all serious adverse events to the Medical Director, Sponsor and IRB in compliance with FDA regulations and sponsor requirements
Provides the Sponsor with accurate and complete documentation and information
Provides accurate and complete documents for IRB submission on a timely basis
Completes and maintains accurate, legible and complete source documents and case report forms per FDA guidelines and Sponsor requirements
Retains and/or forward copies of forms as required by the sponsor
Inform sponsor of prospective FDA audits immediately
Prepares for FDA audits by ensuring all documentation and case report forms are available and complete. Ensure the rights, safety and welfare of all subjects at all times
Ensures that each subject has gone through the informed consent process following GCP guidelines, and consented to participate, before any study related procedures are performed
Provides subject education on an ongoing basis throughout their participation in the protocol
Enters all patients weekly, in a complete, accurate, and timely manner, in the appropriate ECW database and CTMS (Velos)
Utilizes a team approach with all members of the research team; including but not limited to the Principal Investigator, Sub-Investigator, Clinical Research Manager, Clinical Research Coordinators, etc.
Assists in the training of new and current staff members on protocols and delegated role/job requirements
Acts as a liaison to ensure complete and accurate communication between physicians, sponsors and subjects. Work in a collaborative, effective manner with the Sponsor personnel to meet research objectives completely and accurately
Initiates, administrates, and observes intravenous medications (will only be delegated to Clinical Research Coordinators who hold a nursing license)
Understands all internal policies and procedures, and Standard Operating Procedures approved by the Medical Director/Clinical Research Manager

Qualifications & Certifications:
High School Diploma required, plus one of the following:
Licensed Practical Nurse (LPN)
Registered Nurse (RN)
Bachelor’s Degree (BA/BS) with a scientific focus, preferred but not required
2-5 years of clinical research experience is required
Experience with both, ICH E6 Good Clinical Practice guidelines and the FDA Code of Federal Regulations Title 21, is required
Certified Clinical Research Coordinator (CCRC) required
Certifications for selected staff in ACLS, BLS, PALS, GCP, and IATA, will be required, and will be provided if not available at time of hire
Responsibilities related to company mission, culture and engagement:
Actively participate in achieving the company’s Mission, that being to optimize the health of our patients and community by providing compassionate, state of the art care to adults and children with digestive and liver diseases
Adhere to the company’s Code of Conduct, to conduct business with honesty, integrity, and in an appropriate manner for services provided, while ensuring that its business arrangements comply with relevant state and federal statutes and regulations
Consistently work on ways to engage our patients, improve their care experience and maintain strong relationships with referring physician offices and other referral sources.
Create an environment of trust and healthy working relationships
Ability to adapt to changing healthcare environment and lead by example
Exemplify a “can do” attitude and commitment to excellence

Mental/Physical Requirements:
Ability to work well under pressure with diverse groups of professionals and physicians
Requires reasoning ability and good independent judgment
Must demonstrate sensitivity to cultural differences within team and community
May require working under stressful conditions and irregular hours
May require working with frequent interruptions
Work may involve prolonged periods of sitting, standing, lifting, bending, reaching and the ability to push or pull items weighing 30 pounds or less
Required to operate computer keyboard, mouse, and monitor