Qureos Mentor

Cook Children's Health Care System

<div><div>Location:</div><div></div>
Remote - TX<div></div><div>
Department:</div><div></div>
Research Operations<div></div><div>
Shift:</div>
First Shift (United States of America)<div></div><div>
Standard Weekly Hours:</div><div></div>
40<div></div><div>
Summary:</div><div></div><div>
The Regulatory Affairs Coordinator I is new to research regulatory affairs with limited or no regulatory affairs knowledge. May have experience in science, clinical studies or engineering and may understand basic aspects of clinical research. This person is responsible for assisting other regulatory affairs employees with specific tasks including filing, binder preparation and maintenance, basic IRB submissions and communications, essential regulatory document development and maintenance, and audit participation. The Regulatory Affairs Coordinator I will grow their knowledge of regulatory guidelines through ongoing training by internal staff.<br>
<br>
Qualifications:</div><ul><li><div>
Bachelor's degree in appropriate field (e.g., healthcare, social or health science, etc.) and 1-year relevant clinical research, pharmaceutical or regulatory experience required; or an equivalent combination of education/certification and experience from which comparable knowledge and abilities can be demonstrated</div></li><li><div>
Computer proficiency in word processing and Excel required</div></li><li><div>
Knowledge of medical terminology required</div></li><li><div>
Knowledge of principles of research and federal regulations required</div></li><li><div>
Detail-oriented with strong organizational skills</div></li><li><div>
Excellent writing and editing skills</div></li><li><div>
Good interpersonal and communication skills required</div></li><li><div>
IRB Administration or Clinical Research certification required if used in lieu of education</div></li><li><div>
Prefer 2 years&rsquo; experience in clinical research regulatory affairs, including oversight of investigator-initiated and industry-sponsored trials</div></li><li><div>
Ability to support the life cycle of investigator-initiated research projects</div></li><li><div>
Working knowledge of FDA regulations and guidance, including IND, IDE, and amendment submissions</div></li><li><div>
Proactive problem-solving skills to resolve issues to support endowed chair&rsquo;s mission</div></li></ul><div></div><div>
About Us:</div><div></div><div>
Cook Children's Health Care System</div><div></div><div>
Cook Children's Health Care System offers a unique approach to caring for children because we are one of the country's leading integrated pediatric health care delivery organizations. Patients benefit from the integrated system because it allows Cook Children's to use all of its resources to treat a patient and allows for easy communication between the various companies by physicians with a focus on caring for children and adolescents.</div><div></div><div>
Cook Children&rsquo;s is an equal opportunity employer. As such, Cook Children&rsquo;s offers equal employment opportunities without regard to race, color, religion, sex, age, national origin, physical or mental disability, pregnancy, protected veteran status, genetic information, or any other protected class in accordance with applicable federal laws. These opportunities include terms, conditions and privileges of employment, including but not limited to hiring, job placement, training, compensation, discipline, advancement and termination.</div></div>

Regulatory Affairs Coord I

<div><div>Location:</div><div></div>
Prosper Medical Office Building<div></div><div>
Department:</div><div></div>
Oncology Research Operations<div></div><div>
Shift:</div>
First Shift (United States of America)<div></div><div>
Standard Weekly Hours:</div><div></div>
40<div></div><div>
Summary:</div><div></div><div>
The Research Nurse Coordinator implements designated research trials and provides skilled clinical research nursing care to patients and families. Works closely with Principle Investigators to maintain high quality coordination of research through compliance with sponsor specific and regulatory guidelines. The Research Nurse Coordinator will deliver research nursing care to patients and families with a team-orientation, an emphasis on good customer relations, sound clinical judgment, and appropriate decision-making abilities that take into consideration evidenced based practice in line with the research protocol.</div><div></div><div>
Monday - Friday 8am - 5pm<br>
<br>
Education &amp; Experience:</div><ul><li>
Associate's Degree plus RN required.</li><li>
Minimum 3 years of nursing experience required with 2 years research experience or an equivalent combination of education and experience from which comparable knowledge and abilities can be acquired (i.e. BSN and RN plus 3 years of nursing experience).</li><li>
Research experience required.</li></ul><div></div><div>
Knowledge, Skills &amp; Abilities</div><ul><li>
Position requires an individual with: Excellent oral and written communication skills.</li><li>
Detail-oriented and excellent organizational skills.</li><li>
Proficient in Microsoft Office Word and basic knowledge in data entry (i.e. Excel).</li></ul><div></div><div>
Certification/Licensure:</div><ul><li>
Maintains licensure/certification as appropriate to clinical profession.</li><li>
BLS certification required.</li></ul><div></div><div>
About Us:</div><div></div><div>
Cook Children's Health Care System</div><div></div><div>
Cook Children's Health Care System offers a unique approach to caring for children because we are one of the country's leading integrated pediatric health care delivery organizations. Patients benefit from the integrated system because it allows Cook Children's to use all of its resources to treat a patient and allows for easy communication between the various companies by physicians with a focus on caring for children and adolescents.</div><div></div><div>
Cook Children&rsquo;s is an equal opportunity employer. As such, Cook Children&rsquo;s offers equal employment opportunities without regard to race, color, religion, sex, age, national origin, physical or mental disability, pregnancy, protected veteran status, genetic information, or any other protected class in accordance with applicable federal laws. These opportunities include terms, conditions and privileges of employment, including but not limited to hiring, job placement, training, compensation, discipline, advancement and termination.</div></div>

RN, Research Nurse Coordinator

Join Cook Children's Health Care System and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Cook Children's Health Care System

ABOUT_COMPANY

Regulatory Affairs Coord I

RN, Research Nurse Coordinator