Regulatory Affairs Specialist jobs in Columbus, GA

At DaVita Clinical Research, we find that our best leaders are those who create an inspiring vision, have a desire to shape the future of medicine, and empower their team to achieve success. They enjoy tackling difficult problems and believe that the best way to solve them is through a collaborative environment that involves team efforts. They take ownership of results and instill accountability in those they lead. They are driven, compassionate, strong communicators, relationship builders, and find real fulfillment in challenging and impactful work.

Sound like you? Then you might be a great fit for our Regulatory Affairs Coordinator position with DaVita Clinical Research (DCR)

We are looking for a highly committed individual who is seeking to performs tasks associated with the process of regulatory site start-up and regulatory document maintenance in accordance with applicable regulations, standard operation procedures (SOPs), and project requirements based on established protocols and criteria for each study.

This position is based out of our Columbus, GA location.

ESSENTIAL DUTIES & RESPONSIBILITIES:
65% - Coordinate regulatory activities throughout the course of studies for assigned studies at a central level and at assigned Alliance research site. This includes:

• Pre-populate and distribute site regulatory documents to investigative sites

• Collect and perform quality check of site regulatory documents and submit regulatory packages to study sponsors /CROs (Clinical Research Organizations) and/or IRBs (Institutional Review Board) following established requirements.

• Continuing monitoring of all regulatory

• Conduct routine follow-up with sites to ensure issues are resolved and outstanding documentation is completed

15% - Report regulatory document status and start-up activities to project team members and Sponsors/CROs to ensure project timelines are met

10% - Ensure accurate and timely completion of maintenance of internal systems and tracking tools with site and study information.

• This includes inputting key dates, documents and applicable information into the CTMS (Clinical Trial Management System).

5% Provide additional administrative support to the Regulatory Affairs Team, which may include:

• Create and respond to correspondence, facilitate FedEx mailings, scanning, filing, and other related duties

• Other duties and responsibilities as assigned including but not limited to:

• Attend team meetings, phone conferences, and training as needed

• Know, understand, and follow teammate guidelines, employment policies, and department or company procedures

5% - Other duties as assigned.

REQUIREMENTS:

• High School Diploma or equivalent is required

• Bachelor's Degree is preferred

• 1 or more years of Clinical Research experience is preferred

• 1 or more years of Regulatory experience is preferred

• Electronic Trial Master File (eTMF) experience is preferred

• Administrative experience preferred

• Excellent research, analytical and communication skills with ability to interpret legal and technical specifications.

• Excellent verbal and written communication and interpersonal skills and superior organizational and planning skills

• Excellent organizational skills

• Advanced computer skills (MS Word, MS Excel, MS PowerPoint, Adobe Acrobat) is preferred

• Up to 10% travel depending on business needs

• Nights/Weekends: Generally not required; however certain situations/timelines may require night/weekend work.

DaVita Clinical Research (DCR), a wholly owned subsidiary of DaVita Inc., is the research arm of DaVita. DCR innovates through retrospective outcomes research aimed at improving care and quality of life for people with kidney disease. DCR assists pharmaceutical and medical device companies in the design, recruitment and completion of clinical trials using its renal research site network. For 30 years we have helped 500 clients with their development projects. DCR is based in Minneapolis, MN and operates in locations across the US.

DaVita Clinical Research is dedicated to improving the lives of our kidney care patients through:

• Industry sponsored clinical trials in End Stage Kidney Disease and Chronic Kidney Disease

• Internal prospective and retrospective research that helps inform the clinical care of our dialysis facilities and answer critical questions. See our most recent publications: https://www.davitaclinicalresearch.com/media-library/scientific-library/

• Using technology to allow clinical trial enrollment remotely to increase options for patients and enhance patient experience

What We’ll Provide:

More than just pay, our DaVita Rewards package connects teammates to what matters most. Teammates are eligible to begin receiving benefits on the first day of the month following or coinciding with one month of continuous employment. Below are some of our benefit offerings.

• Flexible weekly work schedule: This will vary and is based on current business needs

• December Industry wellness break (Week between Christmas and New Year’s Day)

• Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out

• Support for you and your family: Family resources, EAP counseling sessions, access Headspace®, backup child and elder care, maternity/paternity leave and more

• Professional development programs: DaVita offers a variety of programs to help strong performers grow within their career, and also offers on-demand virtual leadership and development courses through DaVita’s online training platform StarLearning.

Full vaccination against COVID-19 or weekly COVID-19 testing, in addition to wearing a mask, is required. A medical/religious exemption is required for any unvaccinated teammates planning to visit a clinic or working on any of our federal contracts.

At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed Diversity & Belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and an affirmative action employer. As such, individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic.

Salary/ Wage Range

Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies and experience and may fall outside of the range shown. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at https://careers.davita.com/benefits