Interested in a career with both meaning and growth? Whether your abilities are in direct patient care or one of the many other areas of healthcare administration and support, everyone at Parkland works together to fulfill our mission: the health and well-being of individuals and communities entrusted to our care. By joining Parkland, you become part of a diverse healthcare legacy that’s served our community for more than 125 years. Put your skills to work with us, seek opportunities to learn and join a talented team where patient care is more than a job. It’s our passion.

EDUCATION

• Must have a Bachelor’s degree in a health-related field.

EXPERIENCE

• Must have eight (8) years of experience working with patient care processes, as a clinician, researcher or professional in a clinical support service.
• Must have three (3) years of experience working in clinical research, as an analyst or in an operational role.
• Prefer research experience in a hospital setting.

EQUIVALENT EDUCATION AND/OR EXPERIENCE

• Four years’ experience in healthcare or clinical research may substitute for the Bachelor’s degree requirement.

SKILLS OR SPECIAL ABILITIES

• Must have an expert level knowledge of research terminology, design, study methods, ethics, and risk assessment.
• Must have a thorough knowledge of federal regulations specific to research, including human subjects’ protection, drugs, devices, HIPAA regulations, Good Clinical Practices, coverage analysis, research billing and standards for collection, storage and transmission of research data. Must be able to apply research regulations to review of a proposed research study.
• Must be able to demonstrate knowledge of regulatory and Joint Commission standards pertaining to patient care within health care system.
• Must have a strong working knowledge of how research protocols translate into clinical and operational activities.
• Must be able to demonstrate computer skills to input and extract information using word processing, spread sheet, and data base software.
• Must be able to effectively communicate, both orally and in writing.
• Must be able to employ effective problem solving and effective interpersonal skills.
• Must be able to demonstrate patient-centered / patient-valued behaviors.

JOB ACCOUNTABILITIES

• Identifies ways to improve work processes and improve customer satisfaction. Makes recommendations to supervisor, implements, and monitors results as appropriate in support of the overall goals of the department and Parkland.
• Stays abreast of the latest developments, advancements, and trends in the field by attending seminars/workshops, reading professional journals, actively participating in professional organizations, and/or maintaining certification or licensure. Integrates knowledge gained into current work practices.
• Maintains knowledge of applicable rules, regulations, policies, laws and guidelines that impact the area. Develops effective internal controls designed to promote adherence with applicable laws, accreditation agency requirements, and federal, state, and private health plans. Seeks advice and guidance as needed to ensure proper understanding.

PRIMARY PURPOSE

Responsible for leading the review, approval, facilitation and compliance oversight of clinical and health services research conducted at Parkland Health & Hospital System, in order to ensure that research conducted at Parkland meets regulatory, ethical, operational and institutional requirements and proper utilization of Parkland resources.

RESPONSIBILITIES

• Responsible for leading the development and evaluation of clinical research program policies and procedures to meet Parkland Federal Wide Assurance with Office of Human Research Protection (OHRP), DHHS, FDA and Joint Commission requirements for the conduct of safe and ethical research involving Parkland patients, facilities and/or resources.
• Organizes, reviews and facilitates the approval of research proposals submitted to the Clinical Research Office, in order to ensure that research activity meets the objectives of:
• Efficient utilization of resources
• Adherence to policies and procedures to ensure the quality and safety of patient care
• Appropriate completion of coverage analysis
• Appropriate IRB review and approval of study protocol, consent forms, HIPAA authorization and other study documents
• Appropriate review, approval and implementation plan for evaluation of investigational devices
• Appropriate documentation of research team qualifications
• Adequacy of study education/training plan
• Adequate plan for obtaining and securing patient data or samples
• Appropriate review and processing of study modifications
• Works as a liaison between research investigator, patient care divisions, and support departments in order to support these objectives in the implementation of research activity.
• Serves as a resource for the department accountant in setting up research accounts and advising the research team about Parkland research charges.
• Assists with training and mentoring activities, while serving as a resource expert for department employees. Identifies education needs and assists in the education of researchers, hospital managers and staff related to research policies and procedures.
• Responsible for review of more complex studies, assisting with research compliance issues, assisting with research training and education, consulting on research feasibility and special projects as needed.
• Maintains a database for research study identification and tracking of study approval, enrollment and compliance activity. Aggregates, interprets and reports research study information using computer hardware and software programs. Presents results to management and clinicians as requested.
• Serves on interdisciplinary committees as needed.