Sanford Health Senior Clinical Research Specialist - Formal Preceptor/Quality Control in Sioux Falls, South Dakota
Job Title: Senior Clinical Research Specialist - Formal Preceptor/Quality Control | Sioux Falls
City: Sioux Falls
Department : Clinical Research Serv Admins - Sioux Falls
Job Schedule: Full Time
Hours Per Shift: 8 hr
An advanced research position that involves a balance of clinical patient contact, research study coordination, grant, protocol and manuscript development (if applicable), qualitative or quantitative data collection or analysis and management of study data. May spend up to 30 percent of the time providing basic project management assistance to the project management team. Organize complex components of various research projects and clinical trials, including coordination of study required testing and procedures. Also responsible for applicable insurance pre-authorization for study participation. Requires close collaboration with physician investigators to ensure safe and compliant investigational treatment or intervention and follow-up per the established research protocol. May assist in the preparation and submission Institutional Review Board (IRB) documents. Obtains and properly documents informed consent forms from research subjects prior to any study-related procedure. Assures appropriate disposal of sensitive documents. Provides timely notification of Serious Adverse events to the sponsor or delegated representative and the IRB. Prepares for and participates in FDA inspections as needed. Obtain and review inclusion/exclusion criteria and source documents to confirm study eligibility. Prepare case report forms and collect source documents for sponsor or audit review. Ensure drug/device accountability by completing appropriate documentation. Abstract data from medical records, clinic, consultation and referral notes for preparation of study forms and flow sheets. Follows screening, eligibility and enrollment procedures and maintains patient screening/enrollment logs. Follows randomization procedures, schedules subjects, reviews questionnaires completed by subject. Ensures appropriate specimen collection, processing and shipment. Review and document protocol requirements, compliance, deviations and exemptions. Contact subjects for follow-up visits and new information. Listens to, respects, and seeks to accommodate cultural, religious and psychosocial requests within patient and organizational safety guidelines. Enthusiasm for learning and participation in educating patients, physicians, nurses and other personnel to the research process required. Occasional local travel between sites may be required. Attend and participate in investigator meetings. Monitor enrollment goals and modify recruitment plans as necessary.
Establishes and maintains effective working relationship with each team member. Coaches others on clinical skills, knowledge and effective individualized patient care. Carries out difficult interpersonal responsibilities professionally and effectively. Translates vision into specific functional or departmental initiatives. Mediates and resolves conflicts among individuals, groups, and departments. Resolves issues related to collaborative efforts in varying business conditions. Tracks the implementation of plans closely to ensure that desired outcomes are achieved. Develops clear, thorough schedules that deal with a variety of situations. Creates realistic and attainable program of professional development for self. Proceeds without seeking unnecessary permission. Maintains sense of commitment to success, personal achievement and satisfaction. Applies an assigned technique for critical thinking in a decision-making process.
The individual filling this role will also be expected to develop and implement a formal training and orientation plan for new staff. They will develop quality control and Formal Preceptor program. They will participate in cross-functional workgroup (including the Education Coordinator, Monitor(s), Research Compliance, Research Billing Compliance, etc.) to facilitate the development of new staff.
Bachelor’s degree biology, microbiology or related field with at least five years of clinical research or relevant research experience. Bachelor’s degree with three years of clinical research experience and certification from either the Society of Clinical Research Associates, Inc. (SoCRA) or the Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Professional May consider graduates of an accredited school of practical nursing as a Licensed Practical Nurse (LPN) with at least eight years of experience, depending on facility and department needs.
If a Licensed Practical Nurse (LPN), currently holds an unencumbered LPN license with state nursing board and/or possess multi-state licensure privileges. Obtains and subsequently maintains required department specific competencies and certifications. Society of Clinical Research Associates, Inc. (SoCRA) or the Association of Clinical Research Professionals (ACRP) certification desired.
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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City: Sioux Falls
Job Function: Research
Job Schedule: Full Time
Req Number: WD01189