The Cystic Fibrosis Foundation (CF Foundation) and its employees embrace their commitment to its core values. These core values are the pillars on which the CF Foundation stand and will continue to sustain us as we move forward.
- Keep sight of what really matters: Our decisions are based on what is best for people with cystic fibrosis and their families.
- Aspire for excellence in all we do: We take pride in our work. We are committed to continuous learning and improvement.
- Stronger together: We collaborate and work together so that we can learn more and achieve more.
- Innovate with courage: We embrace challenges. We reach beyond boundaries in pursuit of our vision.
- Care about our people: We deeply care about each other and all who support our shared mission. We listen with respect. We support one another.
- The Cystic Fibrosis Foundation – the world’s leader in the search for a cure for cystic fibrosis, and one of the most innovative and successful organizations of its kind – is seeking a Clinical Research Community Engagement Specialist.
We are a nonprofit, donor-supported organization that has raised and invested billions of dollars to help develop cystic fibrosis therapies that have changed the lives of people with this disease. Nearly every CF medicine available today was made possible because of Foundation support.
The Medical Compliance Senior Coordinator will play a role in addressing compliance needs for the Medical Department, working closely with the Manager of Medical Compliance and the larger compliance team and will work with issues related to HIPAA, research, and data security and privacy compliance.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Manages contract review process for multiple contracts including Confidential and Non-Disclosure Agreements (CDA/NDA), and Business Associate Agreements (BAAs) with Care Centers and Medical related CFF subcontractor BAAs, including performing first-tier negotiations, elevating to Manager of Medical Compliance as necessary.
- Manages the maintenance of Medical Department policies and procedures, including their periodic review and update.
- Coordinates and participates in 3rd party compliance assessments, including annual HIPAA Assessments. Works with internal cross functional teams on remediation of issues.
- Participates in audits of internal processes and procedures within or related to the Medical Department, including HIPAA Security and Privacy Audits.
- Participates in the HIPAA Security Committee meetings on a bimonthly basis and presents Security Audit findings to Committee.
- Works closely with the Internal Audit and Risk teams to identify and mitigate Medical Department risks.
- Helps maintain compliance with HIPAA security and privacy regulations and state privacy laws for Medical Department initiatives.
- Works closely with the IT Department to ensure system and data security.
- Support, participate in and facilitate other Medical Compliance projects as needed.
KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
- 2-3 years professional experience.
- Bachelors’ degree required preferably in health-related field.
- Paralegal certification and/or legal or compliance related experience in a healthcare setting required.
- Has knowledge of HIPAA security and privacy provisions.
- Experience conducting audits and/or risk assessments, business process improvement preferred.
- Demonstrates a strong knowledge base of related subject matter through studying and training; comfortable and willing to identify outside training needs/opportunities.
- Ability to identify compliance issues and escalate to supervisor when required.
- Comfortable communicating medical compliance policies and decisions. Comfortable communicating with leadership about medical compliance priorities and decisions.
- Ability to coordinate, manage and track multiple projects in progress.
- Ability to work with IT Department to report, troubleshoot and/or resolve issues.
- Experience with office systems such as Microsoft Outlook, Word, Excel, PowerPoint and other related office systems.
The CF Foundation is an equal opportunity employer that is committed to being an employer of choice, not just a good place to work, but a great and inclusive place to work. We strive to recruit and maintain a diverse workforce. Qualified applicants will receive consideration for employment without regard to race, physical or mental disability, color, religious creed, ancestry, national origin, religion, age, sex, marital status, genetic information or testing, gender identity and expression, sexual orientation or status as a Vietnam-era or special disabled veteran or any characteristic protected by law.
Reasonable Accommodation Notice
The CF Foundation is committed to providing reasonable accommodations for qualified individuals with disabilities in our job application procedures. If you need assistance or would like to request an accommodation due to a disability, please contact us at HROps@cff.org .