Sanford Health Research Compliance Specialist - Clinical Research Serv Admin in Sioux Falls, South Dakota

Job Title: Research Compliance Specialist | Clinical Research Serv Admin | Sioux Falls

City: Sioux Falls

State: South Dakota

Department : CLINICAL RESEARCH - SERV ADMIN

Job Schedule: Full Time

Shift: Days

Hours Per Shift: 8 hr

JOB SUMMARY

Ensure compliance with the federal and state laws, regulations, and rules governing healthcare clinical research trials. This includes the rules and regulations concerning Conditions of Participation, Code of Federal Regulations, Good Clinical Practice and other regulations that govern clinical research trial/studies. Will be expected to review and prepare clinical trial documentation for submission of new clinical trials, annual reviews, amendments, addendums and updates to the Institutional Review Board. Must maintain accurate records and data base for volume of clinical trials in preparation for sponsor, cooperative group or FDA audits and/or inspections. Responsible for organizing and maintaining up to date clinical trial information, including study protocols and informed consent forms, for accurate presentation to physicians and study staff to ensure patient safety. Directly communicates with sponsors, study staff and Institutional Review Board Coordinators as it relates to study specific document modifications and Institutional Review Board requested revisions.Must have health care knowledge or background in clinical research and/or medical terminology. Requires excellent interactive skills, as well as written and verbal communication skills. Must be able to demonstrate appropriate conflict resolution in stressful situations. Must be able to communicate assertively and collaboratively with all staff. Requires excellent organizational skills with attention to detail. Must demonstrate a high level of integrity, ethical conduct, and trust worthiness. Skillful at managing conflict. Must understand and apply a systems approach to problem solving and process improvement involving staff. Must be competent in computer skills i.e. Access, Excel, Word.

POSITION RESPONSIBILITIES

Sanford Research is a multi-site institution and occasional local travel between sites may be required.

QUALIFICATIONS

Must have a Bachelor's Degree. Clinical research or healthcare experience is preferred.

About Sanford Health:

At Sanford Health, we are dedicated to the work of health and healing. Every day, we show that commitment by delivering the highest quality of care to the communities we serve. We are leaders in health care and strive to provide patients across the region with convenient access to expert medical care, leading-edge technologies and world-class facilities.

In addition to strong clinical care, we are also committed to research, education and community growth. We engage in medical research to not only discover innovative ways to provide care, but also cures for common diseases. We continuously seek new ways to achieve our vision of improving the human condition here in your community, across the region and around the world.

The entire team at Sanford Health recognizes the value of healthy families and communities. We continue to gain momentum and expand our reach. Together, we can make a positive difference now, and in the future.

Sanford is an EEO/AA Employer M/F/Disability/Vet. If you are an individual with a disability and would like to request an accommodation for help with your online application, please call 1-877-243-1372 or send an email to talent@sanfordhealth.org .

In compliance with federal law requiring employers to verify new employees' U.S. employment eligibility, Sanford participates in E-Verify. To learn more click here for English Version at https://e-verify.uscis.gov/emp/media/resourcesContents/EverifyPosterEnglish.pdf or here for Spanish Version at https://e-verify.uscis.gov/emp/media/resourcesContents/EverifyPosterSpanish.pdf .

City: Sioux Falls

State: South Dakota

Job Function: Quality & Risk Management

Job Schedule: Full Time

Shift: Days

Req Number: req12581