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The Regulatory Affairs Associate is responsible for front-end and ongoing work related to regulatory start-up, ensuring sites are prepared for trial launch.  Provides oversight throughout the trial ensuring regulatory paperwork is complete and filed throughout the entire trial process, confirming adherence to FDA guidelines.   Manages all files and essential trial documents during the course of the trial.  Maintains all information for audits.  Responsible for the configuration of e-Regulatory System and serves as the SME/Super User, training staff and ensuring adherence to local and federal regulations.  

You’ll enjoy the flexibility to work remotely * from anywhere in the state of IN

Primary Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Provides consultation and expertise to the study team on regulatory requirements Review client/Sponsor requests regarding regulated trials, identify relevant regulations, guidelines, policies and precedence related to client requests (i.e., international harmonization, nonclinical/clinical requirements) Review and interpret regulations and guidelines with respect to product under investigation and/or type of study Provide strategic response to trial team based upon regulatory knowledge, review and interpretation Manages the Essential Trail Documents via the Investigator Site File (ISF)/Regulatory Binder Trains study site staff regarding Regulatory requirements and provides oversight throughout the lifecycle of the trial Continually assesses new and ongoing studies to ensure Regulatory compliance throughout the life of the trial including start-up, maintenance, study close-out and long-term storage of essential documents according to local and national standards Perform internal audits to evaluate for compliance with regulatory standards (i.e., GCP) Provide guidance and consultation for regulatory inspections  Provide consultation and oversight for investigators engaged in Investigator Initiated Trials (IIT) to ensure regulatory compliance Routinely monitor research activities occurring outside the research department (i.e., IIT’s) to ensure compliance with local and federal regulations Prepares for and participates in all audits Develop standard operating procedures to govern essential trial documents, including the use of an e-Regulatory System Configure and maintain e-Regulatory platform Work directly with clients/Sponsors to respond to and resolve queries during external review and/or audits Work with internal and external teams to obtain authorization to conduct clinical trials Manage internal and external project teams to ensure timelines are met Perform gap analysis on needed/expected data and regulatory requirements Advise team on regulated product development procedures and quality measures 

ADMINISTRATIVE FUNCTIONS

Interface with IRB’s, Sponsor, CRO’s and OCRI Advocate for AHN within OCRI, Optum & UHG Provides progress reports to the study team Maintains Investigator Site File (ISF)/Regulatory Binder, directing staff in proper procedure

OTHER FUNCTIONS

Attends meetings and participates on committees as necessary Reviews current literature and attends training sessions and seminars to keep informed of new developments in the field Performs other related duties and responsibilities as directed

You’ll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.

Required Qualifications:

Medical License/Certification  Experience in clinical regulatory affairs  Knowledge of research terminology and FDA regulatory requirements Proficient computer skills, including working knowledge of Microsoft Office Suite, e-mail systems, and web-based programs Proven ability to read and interpret documents such as professional journals and government regulations Proven ability to write reports, business correspondence Proven ability to effectively present information and respond to questions from groups of managers, employees, clients, customers, and the general public Proven ability to interact and communicate with a variety of people, both on a one-on-one basis and in meetings and group presentations; must be able to relate to and work with ill, emotionally upset, and sometimes hostile people Proven ability to anticipate and react calmly to emergency situations Proven ability to work with mathematical concepts such as probability and statistical inference; ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations Proven ability to follow direction Proven ability to think logically in order to troubleshoot, analyze situations, and make appropriate decisions Proven ability to handle multiple tasks simultaneously

PHYSICAL DEMANDS

The physical demands described here are representative of those an individual must meet to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Ability to work in a fast-paced office environment Solid sensory skills, such as visual acuity, good hearing, and dexterity Ability to stand and sit for periods of time and to move constantly throughout the workday Good speaking and listening skills Ability to perform focused work with close attention to detail Ability to operate office equipment, including computers, copiers, fax machines, and phones Ability to interact with others, both in person and through phone, e-mail, and written correspondence Ability to push, pull, lift, move, and/or carry up to 15 pounds

*All employees working remotely will be required to adhere to UnitedHealth Group’s Telecommuter Policy 

Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with us, you’ll find a far-reaching choice of benefits and incentives. The salary for this role will range from $48,700 to $87,000 annually based on full-time employment. We comply with all minimum wage laws as applicable. 

Application Deadline: This will be posted for a minimum of 2 business days or until a sufficient candidate pool has been collected. Job posting may come down early due to volume of applicants.

At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone–of every race, gender, sexuality, age, location and income–deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes — an enterprise priority reflected in our mission.

OptumCare is an Equal Employment Opportunity employer under applicable law and qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

OptumCare is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.