Specialist-Research-Regulatory

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Job description

We Are Hiring: The Research Regulatory Coordinator leads, coordinates and oversees regulatory processes across multiple studies of different therapeutic areas and phases, in accordance with appropriate regulations, institutional policies, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes independently. Studies may be large, nationwide, or moderately complex involving multiple sites and/or assessments/interventions.

DUTIES:
• Manages regulatory activities for all stages of clinical trials for assigned department (s). Prepares and submits regulatory documents to Sponsor and IRB and works with the clinical research team to ensure submission documents are up-to-date
• Maintains a working knowledge of all federal, state, and institutional guidelines regarding clinical trials. Provides guidance and training to research staff to ensure compliance with rules and regulations associated with clinical research studies
• Completes industry registrations and study feasibility questionnaires including receipt, tracking and correspondence with Sponsor/CRO/
• Prepare and submit start-up regulatory packets to Sponsor and IRB
• Oversee study start-up activities to including reporting and communicating with stakeholders on a regular basis
• Serve as a liaison to Sponsors/CRO/IRB/Investigators assuring continuity of service and problem resolution
• Monitor approval status of open studies by completing timely reviews
• Maintain master files of all regulatory-related documents
• Assist in submission of Investigational New Drug (IND) applications including amendments and reporting
• Coordinate schedules of on-site visits including introductions, tours, EMR access and Sponsor/CRO/ARO requests, and monitoring visits Your exceptional skills
• Ability to be detail oriented
• Ability to be organized
• Ability to perform basic computer functions
• Ability to use customer service skills to provide an exceptional experience
• Ability to work effectively within a team environment
• Must be able to prioritize tasks; work well under stress, meet aggressive timelines, and problem solve to quickly and tactfully manage challenging situations concerning customer groups
•Must be willing to work flexible hours if needed
• Must demonstrate intermediate competency in the use of the Internet and the following Microsoft applications: Word, Excel, Outlook
Personal Characteristics
• Ability to communicate effectively both orally and in writing
What You Will Do: Create and submit all required regulatory submissions related to research studies conducted by the organization.

Responsibilities:

• Coordinate, prepare, review, and submit required regulatory documentation.
• Review and recommend changes to departmental policies, procedures and standards commensurate with regulatory developments.
• Review and researche pertinent trends, issues, and developments in research and disseminate information to staff. Maintain regulatory references and materials.
• Collaborate on the management of regulatory-related issues including serious adverse events and human subject participation.

What You Will Need: Licensure / Certification / Registration:

• Research Professional preferred.

Education:

• High school diploma/GED with 2 years of experience, or Associate's degree, or Bachelor's degree required.

Work Experience:

• 3 years of experience preferred.

Additional Preferences: No additional preferences.
Why Join Our Team: Ascension is a faith-based healthcare organization dedicated to transformation through innovation across the continuum of care. As one of the leading non-profit and Catholic health systems in the U.S., Ascension is committed to delivering compassionate, personalized care to all. In FY2020, Ascension provided $2.4 billion in care of persons living in poverty and other community benefit programs. Ascension includes more than 160,000 associates and 40,000 aligned providers across a national network of ministries. We offer rewarding careers across more than 2,600 sites of care - including 146 hospitals and more than 50 senior living facilities - in 19 states and the District of Columbia."}" data-sheets-userformat="{"2":6975,"3":{"1":0},"4":{"1":2,"2":},"5":{"1":[{"1":2,"2":0,"5":{"1":2,"2":0}},{"1":0,"2":0,"3":3},{"1":1,"2":0,"4":1}]},"6":{"1":[{"1":2,"2":0,"5":{"1":2,"2":0}},{"1":0,"2":0,"3":3},{"1":1,"2":0,"4":1}]},"7":{"1":[{"1":2,"2":0,"5":{"1":2,"2":0}},{"1":0,"2":0,"3":3},{"1":1,"2":0,"4":1}]},"8":{"1":[{"1":2,"2":0,"5":{"1":2,"2":0}},{"1":0,"2":0,"3":3},{"1":1,"2":0,"4":1}]},"11":4,"12":0,"14":{"1":2,"2":0},"15":"Arial"}">Serving the greater Indianapolis area and Evansville, Indiana, Ascension St. Vincent has been providing rewarding careers in healthcare for over 148 years. We operate 24 hospitals - in addition to outpatient health centers, physician offices, rehabilitation centers and more - and offer careers in a wide range of services. We provide generous paid time off for work-life balance, a collaborative work environment, professional development opportunities, and more to help our associates flourish personally and professionally. When you join Ascension St. Vincent, you join a diverse team of more than 15,000 associates and 3,000 providers who are dedicated to providing compassionate, personalized care to all - especially to those most in need. If you are looking to make an immediate impact in your community, explore a career with us today.

When you join Ascension, you join a team of over 150,000 individuals across the country committed to a Mission of serving others and providing compassionate, personalized care to all. Our inclusive culture, continuing education programs, career coaches and benefit offerings are just a few of the resources and tools that team members can use to create a rewarding career path. In fact, Ascension spent nearly $46 million in tuition assistance alone to support associate growth and development. If you are looking for a career where you can grow and make a difference in your community, we invite you to join our team today.

Equal Employment Opportunity Employer:
Pay Non-Discrimination Notice:

For further information regarding your EEO rights, click on the following link to the "EEO is the Law" poster:

EEO is the Law Poster Supplement

Please note that Ascension will make an offer of employment only to individuals who have applied for a position using our official application. Be on alert for possible fraudulent offers of employment. Ascension will not solicit money or banking information from applicants."}" data-sheets-userformat="{"2":,"3":{"1":0},"5":{"1":[{"1":2,"2":0,"5":{"1":2,"2":0}},{"1":0,"2":0,"3":3},{"1":1,"2":0,"4":1}]},"6":{"1":[{"1":2,"2":0,"5":{"1":2,"2":0}},{"1":0,"2":0,"3":3},{"1":1,"2":0,"4":1}]},"7":{"1":[{"1":2,"2":0,"5":{"1":2,"2":0}},{"1":0,"2":0,"3":3},{"1":1,"2":0,"4":1}]},"8":{"1":[{"1":2,"2":0,"5":{"1":2,"2":0}},{"1":0,"2":0,"3":3},{"1":1,"2":0,"4":1}]},"9":0,"10":1,"11":4,"12":0,"16":10,"23":1}" data-sheets-textstyleruns="{"1":0,"2":{"2":{"1":2,"2":}}}{"1":21}{"1":392,"2":{"2":{"1":2,"2":0}}}{"1":393,"2":{"2":{"1":2,"2":},"9":1}}{"1":485}{"1":486,"2":{"2":{"1":2,"2":},"9":1}}{"1":487}{"1":598,"2":{"2":{"1":2,"2":0}}}{"1":599,"2":{"2":{"1":2,"2":},"9":1}}{"1":663}{"1":664,"2":{"2":{"1":2,"2":0}}}{"1":665,"2":{"2":{"1":2,"2":},"9":1}}{"1":697}" data-sheets-hyperlinkruns="{"1":392,"2":""}{"1":484}{"1":598,"2":""}{"1":662}{"1":664,"2":""}{"1":696}">Ascension St. Vincent is an Equal Employment Opportunity (EEO) and Affirmative Action employer. Associates and Applicants receive fair and impartial consideration without regard to race, color, religion, national origin, citizenship, gender identity, sexual orientation, age, physical or mental disability, veteran status, genetic data, or other legally protected status.

Pay Non-Discrimination Notice:

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For further information regarding your EEO rights, click on the following link to the "EEO is the Law" poster:

f

EEO is the Law Poster Supplement

Please note that Ascension will make an offer of employment only to individuals who have applied for a position using our official application. Be on alert for possible fraudulent offers of employment. Ascension will not solicit money or banking information from applicants.
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