Research Compliance Specialist - Clinical Research
Job Title: Research Compliance Specialist | Clinical Research | Fargo
Department *: * Clinical Research North-Ind - Research Compliance - Fargo
Job Schedule: Full Time
Hours Per Shift: 8 hr
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. Reviews and prepares clinical trial documentation for submission of new clinical trials, annual reviews, amendments, addendums, and updates to the Institutional Review Board (IRB). Maintains accurate records and data base for volume of clinical trials in preparation for sponsor, cooperative group or Food and Drug Administration (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 IRB Coordinators as it relates to study specific document modifications and IRB requested revisions. Possesses healthcare knowledge or background in clinical research and/or medical terminology. Possesses excellent interactive kills, as well as written and verbal communication skills. Ability to demonstrate appropriate conflict resolution in stressful situations. Ability to communicate assertively and collaboratively with all staff. Works with ancillary departments to ensure completion. Adds and removes team members. Possesses excellent organizational skills with great attention to detail. Demonstrates a high level of integrity, ethical conduct, and trustworthiness. Skillful at managing conflict. Understands and applies a systems approach to problem solving and process improvement involving staff. Competent in computer skills (i.e. Access, Excel, and Word). Sanford Research is a multi-site institution and occasional local travel between sites may be required.
Checks documents thoroughly according to standard processes and procedures. Prepares written text and layout of materials according to required outlines and specifications. Participates in clinical research activities according to study protocols. Instruct research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures. Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Prepare study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports. Demonstrates the ability to meet deadlines. Undertakes the accurate and complete collection of clinical data and selects appropriate forms for recording of data. Follows standard operating procedures for the preparation, undertaking and closure of clinical research. Demonstrates experience participating in productive collaborative processes.
Bachelors degree is required.
Healthcare Science background is preferred. Two years experience is required.
Certification is encouraged.
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.
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Job Function: Legal and Compliance
Job Schedule: Full Time
Req Number: WD05738