System Research Regulatory Lead, Day Shift, Cardiology

Rockville, MD
May 20, 2023
Jun 03, 2023
Analyst, Research
Full Time
Shady Grove Medical Center seeks to hire an experienced System Research Regulatory lead for our Cardiology Department who will embrace our mission to extend God's care through the ministry of physical, mental and spiritual healing.

As a System Research Regulatory Lead, you will:
• Prepare and submission of regulatory documents to AHC IRB and central IRB.
• Ensures and guarantees regulatory compliance for all clinical trials
• Creation and oversee the initiation, development, and revision of the informed consents, and other study and clinical research documentation.
• Serves as regulatory lead for internal and external agencies, interfacing with sponsors and agencies to ensure compliance with all applicable local, state, and federal regulations, statutes, and laws.
• Creates and provides solutions to problems, negotiating compromises, and proposing alternatives and recommendations to facilitate and expedite research.
• Escalates issues as needed, and as requested and/or required by sponsors, participates in and facilitates monitoring visits.
• Participates in and completes study activations and regulatory activities. Oversees data management activities and process maintenance of electronic regulatory files and binders with information pertinent to studying milestone.
• Reviews documentation to support regulatory filings and prepares annual progress reports for IRB renewal of ongoing studies.
• Stays up to date with new and revised standard operating procedures and regulations associated with clinical research studies and trials involving human subjects.
• Alerts appropriate staff to changes and ensures appropriate interpretation and application to new and existing studies and trials.
• Maintains compliance with good clinical practice (GCP) guidelines, patient confidentiality (HIPAA) and any other applicable laws.
• Attends and participates in regular leadership meetings. Supports departmental education efforts, helping ensure highest quality research and protection of human subjects.
• Promote research regulatory requirements. Completes and submits adverse event reports according to department- and sponsor-specific requirements.

Qualified candidates will possess:
• Bachelor's degree or above
• 4 years within research
• Min 1-2 years of experience in leading a team.

Work Schedule:

Will cover regulatory matters for multiple sites within AHC.

At Adventist HealthCare our job is to care for you.

We do this by offering:
  • Work life balance through nonrotating shifts
  • Recognition and rewards for professional expertise
  • 403(b) retirement plan
  • Free Employee parking
  • Benefits Eligible Positions:
    • Competitive, comprehensive benefit plans [including health, employer-paid disability and life insurance, PTO]
    • Employer retirement contribution and match after 1-year of eligible employment with 3 year vesting
    • Ancillary benefits such as flexible spending, legal and pet insurance to meet the needs of employees and their eligible family members
    • Subsidized childcare at participating childcare centers

As a faith-based organization, with over a century of caring for the communities in the Maryland area, Adventist HealthCare has earned a reputation for high-quality, compassionate care. Adventist HealthCare was the first and is the largest healthcare provider in Montgomery County.

If you want to make a difference in someone's life every day, consider a position with a team of professionals who are doing just that, making a difference.

Join the Adventist HealthCare team today, apply now to be considered!

COVID-19 Vaccination

Adventist HealthCare requires all applicants to be fully vaccinated for COVID-19 before commencing employment. Applicants may be required to furnish proof of vaccination and , if offered, may elect to be vaccinated at a n designated Adventist HealthCare location.

Tobacco and Drug Statement

Tobacco use is a well-recognized preventable cause of death in the United States and an important public health issue. In order to promote and maintain a healthy work environment, Adventist HealthCare will not hire applicants for employment who either state that they are nicotine users or who test positive for nicotine and drug use.

While some jurisdictions, including Maryland, permit the use of marijuana for medical purposes, marijuana continues to be classified as an illegal drug under the federal Controlled Substances Act. As a result, medical marijuana use will not be accepted as a valid explanation for a positive drug test result.

Adventist HealthCare will withdraw offers of employment to applicants who test positive for Cotinine (nicotine) and marijuana. Those testing positive are given the opportunity to re-apply in 90 days, if they can truthfully attest that they have not used any nicotine products in the past ninety (90) days and successfully pass follow-up testing.

Equal Employment Opportunity

Adventist HealthCare is an Equal Opportunity/Affirmative Action Employer. We are committed to attracting, engaging, and developing the best people to cultivate our mission-centric culture. Our goal is to have a welcoming, equitable, and safe place to work and grow for all employees, no matter their background. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.

Adventist HealthCare will make reasonable accommodations for applicants with disabilities, in accordance with applicable law. Adventist HealthCare is a religious organization as defined under applicable law; however, it will endeavor to provide reasonable accommodations for applicants' religious beliefs.

Applicants who wish to request accommodations for disabilities or religious belief should contact the Support Center HR Office.

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