Federal Regulatory Affairs Coordinator

Description

Prepares, facilitates, coordinates, and submits documentation required by federal, state and local regulations and institutional requirements relating to the conduct of research. This includes preparation of all submissions to the IRB to assure the protection of human subjects in research; FDA-required submissions which may include investigator 1572 forms, investigational new drug applications, device submissions such as Emergency use, HDE, Safety Reports, and other documents that may be required by a regulatory agency or the institution. Leads the work of Research Assistants on a task-basis if applicable. Provides on-the-job training, sets priorities and schedules workflow required to support project objectives.

• Prepares applications for initial submission to Institutional Review Board (IRB) for review including: completes required application forms, creates consent forms to meet SMC standards, collects appropriate supporting documents (i.e. IND information, questionnaires, letters, investigational drug brochures, 1571 s, etc.) and responds to Institutional Review Office and Institutional Review Board requests.
• Prepares applications for ongoing annual review by the IRB including: completes required annual report form, updates consent form, collects information regarding results of study or findings to date, adverse events experienced, etc.
• Prepares applications for protocol modification for submission to the IRB including: complete Protocol Modification Form (s), review and identify changes to be reviewed, updating consent forms, etc.
• Submits Safety Adverse Event (SAE) Reports to IRB as required by sponsors and, if appropriate, make changes to the consent form to reflect new information about adverse events; provide support to staff in completing local SAE Reports for submission to study sponsors and the IRB.
• Prepares federal reporting documents including, but not limited to: PHS 310 forms, FDA 1571 and 1572 forms.
• Serves as information specialist for regulatory questions from staff, coordinators, researchers, etc.
• Serves as liaison between sponsors, researchers, staff, and study coordinators.
• Coordinates and negotiates with commercial study sponsors with regards to consent form language.
• Supports research efforts in general by maintaining and tracking study databases and study files, supporting researchers, maintaining an IRB correspondence file, and providing support to research staff to facilitate study review (i.e. drafting letters, database reports, data updates, etc.).
• Develops and maintains regulatory knowledge for human subject protections.

Required Qualifications

• Bachelor's Degree preferably in science, healthcare, or other related field, Or
• Significant experience in research coordination or regulatory work may be substituted for educational requirements.
• 2 years experience in healthcare, research or clinical setting with regulatory compliance familiarity.

Our best-in-class benefits are uniquely designed to support you and your family in staying well, growing professionally and achieving financial security. We take care of you, so you can focus on delivering our mission of improving the health and wellbeing of each patient we serve.

About Providence

At Providence, our strength lies in Our Promise of Know me, care for me, ease my way. Working at our family of organizations means that regardless of your role, we ll walk alongside you in your career, supporting you so you can support others. We provide best-in-class benefits and we foster an inclusive workplace where diversity is valued, and everyone is essential, heard and respected. Together, our 120,000 caregivers (all employees) serve in over 50 hospitals, over 1,000 clinics and a full range of health and social services across Alaska, California, Montana, New Mexico, Oregon, Texas and Washington. As a comprehensive health care organization, we are serving more people, advancing best practices and continuing our more than 100-year tradition of serving the poor and vulnerable.

About The Team

Swedish is the largest not-for-profit health care system in the greater Seattle area. It is comprised of five hospital campuses (First Hill, Cherry Hill, Ballard, Edmonds and Issaquah); emergency rooms and specialty centers in Redmond (East King County) and the Mill Creek area in Everett; and Swedish Medical Group, a network of more than 128 primary care and specialty care locations throughout the Puget Sound. Swedish, named a LinkedIn Top Company to grow your career, employs nearly 13,000 caregivers (all employees), including nearly 1,400 providers. Whether through physician clinics, education, research and innovation or other outreach, we're committed to caring for the people in our region and beyond.

We are committed to the principle that every workforce member has the right to work in surroundings that are free from all forms of unlawful discrimination and harassment.

We are committed to cultural diversity and equal employment for all individuals. It is our policy to recruit, hire, promote, compensate, transfer, train, retain, terminate, and make all other employment-related decisions without regard to race, color, religious creed (including religious dress and grooming practices), national origin (including certain language use restrictions), ancestry, disability (mental and physical including HIV and AIDS), medical condition (including cancer and genetic characteristics), genetic information, marital status, age, sex (which includes pregnancy, childbirth, breastfeeding and related medical conditions), gender, gender identity, gender expression, sexual orientation, genetic information, and military and veteran status or any other applicable legally protected status. We will also provide reasonable accommodation to known physical or mental limitations of an otherwise qualified caregiver or applicant for employment, unless the accommodation would impose undue hardship on the operation of our business.

We are a community where all people, regardless of differences, are welcome, secure, and valued. We value respect, appreciation, collaboration, diversity, and a shared commitment to serving our communities. We expect that all workforce members in our community will act in ways which reflect a commitment to and accountability for, racial and social justice and equality in the workplace. As such, we will maintain a workplace free of discrimination and harassment based on any applicable legally protected status. We also expect that all workforce members will maintain a positive workplace free from any unacceptable conduct which creates an intimidating, hostile, or offensive work environment.

Requsition ID: 132067

Company: Swedish Jobs

Job Category: Research

Job Function: Clinical Support

Job Schedule: Full time

Job Shift: Day

Career Track: Clinical Professional

Department: 3909 SRE CLINICAL TRIALS RESEARCH

Address: WA Seattle 801 Broadway

Swedish Health Services is proud to be an Equal Opportunity Employer. Providence does not discriminate on the basis of race, color, gender, disability, veteran, military status, religion, age, creed, national origin, sexual identity or expression, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law.