[New Job Vacancy] Clinical Research Coordinator job in MSO – Texas Back Institute, (Plano, TX 75093) – Jobs in Plano, TX 75093

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Job Opening details:-
Company Name :-
MSO – Texas Back Institute
Position Name :-
Clinical Research Coordinator
Company Location :-
Plano, TX 75093
Job Category :
 data entry Jobs

Full Job Description :-
Description
Introduction
Are you passionate about the patient experience? At HCA Healthcare, we are committed to caring for patients with purpose and integrity. We care like family! Jump-start your career as a(an) Clinical Research Coordinator today with MSO – Texas Back Institute.
Benefits
We are committed to providing our employees with the support they need. At MSO – Texas Back Institute, we offer eligible colleagues an attractive benefit package that includes medical, wellbeing, dental and vision benefits along with some unique benefits including:

Medical, Dental, Vision, Life Insurance and Flexible Spending
Paid Time Off (PTO) and Personal Leave
401K (100% annual match – 3% to 9% of pay based on years of service)
Academic Assistance and Reimbursements for Tuition and Student Loans
Employee Discounts including Tickets, Retail, Mental Health Apps, Education Apps, Identity Theft Protection etc.
Home, Auto, and Pet Insurance
Employee Stock Purchase Program (ESPP)
Short Term & Long Term Disability coverage
Adoption Assistance
Legal Benefits and lots more!

Learn more about Employee Benefits
Come join our team as a(an) Clinical Research Coordinator. We care for our community! Just last year, HCA Healthcare and our colleagues donated $13.8 million dollars to charitable organizations. Apply Today!
Job Summary and Qualifications

Position Summary
The Clinical Research Coordinator (CRC) at Texas Back Institute (TBI) is a specialized research professional working with and under the direction of the Clinical Research Manager (CRM) and the Director of Clinical Research. The CRC is responsible for the screening, enrollment and follow-up activities of study subjects enrolled in assigned protocols and for other research-related tasks assigned. The CRC is responsible for assisting the PI and Sub-Investigators (SI) in maintaining compliance and adherence to all regulating agencies concerning clinical research. This is a full time, on-site position and requires patient/subject contact.
Duties and Responsibilities

Coordinate clinical research protocols, achieving contracted enrollment with minimal lost to follow up patients.
Maintain the storage and accountability of investigational drugs or devices for assigned studies.
Develop and maintain professional relationships with industry partners, CRO’s, research investigators and company’s clinical and business operations divisions.
Foster a patient-care culture that emphasize patient safety and quality in all aspects.
Positively represent the company at sponsor investigator meetings, national conferences and within the clinical practice.
Maintain a high knowledge of clinical research practice standards and regulatory requirements.
Coordinate on-site and zoom/web conferencing for routine monitoring visits.
Coordinate routine monitoring visits for assigned studies.
Develop study documents such as protocol summaries, informed consent forms (ICF), source documents and study enrollment plans.
Maintain in-depth understanding of assigned study protocols and related procedures required during the life of the study.
Provide oversight with the set up and maintenance of protocol regulatory binders/trial master file (TMF) for assigned studies.
Coordinate the archival of closed protocol documents of assigned studies.
Maintain subject screening and enrollment log for assigned studies; submit to sponsors as required per study.
Maintain effective and ongoing communication with CRO/sponsor, applicable research staff, and supervisor.
Protect the rights and welfare of all human research participants involved in research.
Develop and complete case report forms (CRF).
Schedule subjects for research-related visits.
Screen patients for potential enrollment into studies through chart reviews for assigned studies.
Set up subject source document folders and ensure documentation is available prior to subject visits for assigned studies.
Review potential studies for feasibility and provides feedback to research team.
Conduct informed consent process, ensuring patients/subjects are fully educated on study in order to make an informed decision for participation
Perform study-related procedures and data collection at specific timepoints as defined by the specific protocol.
Responsible for the screening, enrollment and follow-up activities associated with subject visits for all assigned drug and device studies.
Report adverse events as required by protocol and regulatory agencies; provide follow-up as needed on all adverse events.
Document protocol violations and report to sponsor and regulatory agencies; develop plan to eliminate further episodes of violation.
Perform all research activities in compliance with Good Clinical Practice (GCP), Food and Drug Administration (FDA), federal and local regulations, Institutional Review Board (IRB), Health Insurance Portability and Accountability Act (HIPAA) and other applicable regulations and guidelines.
Utilize clinical trial management system or other similar program(s) to manage subject visit data and other research activity.
Perform or schedule sample collection (i.e., biopsy/tissue samples, lab samples, scans, PK samples) as per protocol.
Obtain and maintain in-depth understanding of assigned study protocols and related procedures required during the life of the study.
Review post-monitor visit follow-up letter and address all outstanding issues in a timely manner.
Perform site study start-up activities to ensure TBI meets sponsor, IRB and other regulatory authority’s requirements.
Prepare archival of closed protocol documents.
Prepare, review and execute regulatory submissions to the Institutional Review Board (IRB), to include but not limited to, continuing review, serious adverse events (SAE), protocol and Investigator Brochure amendments, protocol violations, advertisements.
Perform other coordinator duties as required or assigned.

Qualifications:

Minimum one (1) to two (2) years of experience in clinical research, focusing on drug and device studies.
Bachelor’s degree or equivalent experience in education and experience in a life science, nursing training or other form of medical certification is preferred; experience in spine preferred.
Active Certified Clinical Research Coordinator (CCRC) through ACRP or Certified Clinical Research Professional (CCRP) through The Society of Clinical Research Associates (SOCRA) or obtains when eligible..

Job Competencies

Must have a growth mindset, be a self-starter and be “hands-on” and have ability to work in a fast-paced environment.
Strong IT skills – advanced working knowledge with Microsoft Office to include, Outlook, Work, Excel and PowerPoint and various research data entry programs such as InForm, Medidata Rave, Bioclinica, Oracle, etc.

Work well with others and willingness to take on variety of clinical and non-clinical duties; demonstrate teamwork with ability to work with and assist others when needed.
Display a positive attitude and optimism about the organization and work to be done.
Familiarity with ICH Good Clinical Practice Guidelines
Familiar with medical terminology.
Demonstrated organizational skills and attention to detail.
Ability to work independently.
Proficient in the use of general office equipment.
Proficient data entry and typing skills.
Punctual and sensitive to work schedules.
Exhibit flexibility and adaptability.
Spine and/or orthopedic research experience preferred.
Excellent verbal and non-verbal interpersonal and communication skills.
Demonstrate knowledge of writing accurate business reports and correspondence.
Able to communicate and respond appropriately to questions from physicians, patients and family members.
Proficiency in Centricity preferred or have worked with other electronic medical records.
Demonstrate a high level of accountability and strong work ethics.
Ability to multi-task throughout the day, maintaining composure and focus.
Ability to read, interpret, and apply clinical information to safety enroll and assess study participants.
Ability to multi-task, establish priorities, and time-manage.
Show sensitivity and respect to the needs and feelings of internal and external customers with appropriate customer service
Displays excellent customer service skills for both internal and external customers.
Is dependable and reliable with meeting goals, deadlines and other performance expectations
Candidates should be highly motivated with a professional demeanor who are well organized, detail oriented and have good people skills.

Physical Requirements

While performing the duties of this job, the employee is regularly required to sit or stand for extended periods. The employee is frequently required to speak, hear and use hands and fingers to handle or feel and carry boxes/supplies of 40 lbs. or less. May be exposed to bodily fluids. Must be able to wear applicable personal protective equipment (PPE) as needed. May have local and non-local travel. Must have a valid driver’s license, insurance and dependable transportation.

Physician Services Group is skilled in physician employment, practice and urgent care operations. We are experts in hospitalist integration, and graduate medical education. We lead more than 1,300 physician practices and 170+ urgent care centers. We are HCA Healthcare’s graduate medical education leader. We provide direction for over 260 exceptional resident and fellowship programs. We focus on carrying out value-added solutions. These solutions help physicians deliver patient-centered healthcare. We support HCA Healthcare’s commitment to the care and improvement of human life.

HCA Healthcare has been named one of the World’s Most Ethical Companies by Ethisphere Institute for over a decade. In recent years, HCA Healthcare spent an estimated $3.7 billion in cost for the delivery of charitable care, uninsured discounts, and other uncompensated expenses.

“The great hospitals will always put the patient and the patient’s family first, and the really great institutions will provide care with warmth, compassion, and dignity for the individual.”- Dr. Thomas Frist, Sr. HCA Healthcare Co-Founder
If you are looking for an opportunity that provides satisfaction and personal growth, we encourage you to apply for our Clinical Research Coordinator opening. We promptly review all applications. Highly qualified candidates will be contacted for interviews. Unlock the possibilities and apply today!
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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