Research Safety and Compliance Specialist

BJC HealthCare • Des Peres, MO

1d

About The Position

Missouri Baptist Medical Center, an acute care hospital in St. Louis County, offers a full continuum of medical and surgical services, including heart care, cancer, women and infants, breast health, gastrointestinal, orthopedic, stroke, therapy, wound and pain management services. The hospital has a 24-hour adult emergency department and cares for pediatric patients at a separate emergency department in collaboration with St. Louis Children’s Hospital.
Missouri Baptist is the first and only hospital in St. Louis County to be named a Magnet® hospital by the American Nurses Credentialing Center (ANCC). The prestigious designation is the highest credential a health care organization can receive for nursing excellence and quality patient care. This recognition has been accomplished by less than nine percent of hospitals nationwide. Additionally, U.S. News & World Report ranked the hospital #2 in the St. Louis metro area.
The Research Administration team coordinates all patient research activities at Missouri Baptist in accordance with regulatory guidelines and utilization of hospital resources.
Role Purpose
This position will assist with the development and implementation of foundational documents and processes for the BJC Research Safety & Compliance Program. This position will support this systemwide program to help ensure that clinical trials and other research related activities are conducted in a safe, ethical, and compliant manner with consideration for BJC health service organization (HSO) resources and operations. This position will help facilitate the processes and coordination required to initiate complex clinical study protocols safely and in compliance with regulations, standards, policies and guidelines applicable to research conducted in BJC HSOs. Certification in Health Care Research Compliance (CHRC) or equivalent within two years.
Serve as the gatekeeper for research conducted at MBMC
Review and interpret research protocols to assess clinical and operational impact
Ensure research activities align with institutional guidelines and compliance standards
Support research safety oversight within clinical operations
Apply experience-based judgment when making decisions within established guidelines
Identify potential issues proactively and recommend solutions
Collaborate with clinical teams, and leadership
Communicate clearly and effectively across departments

Requirements

• Bachelor's Degree - Business/Nursing/related
• <2 years
• RN
• BJC has determined this is a safety-sensitive position. The ability to work in a constant state of alertness and in a safe manner is an essential function of this job.

Nice To Haves

• Registered Nurse Preferred
• Research experience required
• Detail-oriented with strong organizational skills
• Ability to read and understand research protocols
• Strong critical thinking and problem-solving skills
• Self-motivated and able to work independently
• Comfortable making informed decisions based on experience
• Research study start-up experience preferred
• Master's Degree - Healthcare related field
• 2-5 years
• Certification in Health Care Research Compliance (CHRC) or equivalent within two years.

Responsibilities

• Supports the development, implementation and sustainment of BJC Research Safety and Compliance Program components to ensure patient and employee safety and compliance with BJC HSO accreditation standards, hospital and ASC licensure regulations, CMS CoPs, CMS provider-based rules and other regulatory requirements, including those specific to research.
• Works collaboratively with research principal investigators and their teams to address identified safety and/or compliance issues related to pending or active research in BJC HSOs.
• Facilitates communication between researchers and BJC clinical leaders through committees and meetings, written messages and education on regulations, standards, policies and guiding documents to help ensure safe coordination of clinical care, in compliance with BJC requirements, for BJC patients enrolled in clinical studies.
• Assists with projects to develop or improve processes required to support the infrastructure of a systemwide Research Safety and Compliance Program.
• Provides education to research teams and BJC team members on accreditation standards, internal and external regulations, policies, guidelines, and standards related to clinical studies conducted in BJC healthcare organizations.

Benefits

• Comprehensive medical, dental, vison, life insurance, and legal services available first day of the month after hire date
• Disability insurance paid for by BJC
• Annual 4% BJC Automatic Retirement Contribution
• 401(k) plan with BJC match
• Tuition Assistance available on first day
• BJC Institute for Learning and Development
• Health Care and Dependent Care Flexible Spending Accounts
• Paid Time Off benefit combines vacation, sick days, holidays and personal time
• Adoption assistance

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level