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Senior Clinical Research Specialist - Formal Preceptor/Quality Control - Clinical Research

Employer
Sanford Health
Location
Fargo, North Dakota
Salary
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Job Details


Job Title: Senior Clinical Research Specialist - Formal Preceptor/Quality Control | Clinical Research | Fargo

City: Fargo

State: North Dakota

Department *: * CLINICAL RESEARCH - SERV ADMIN

Job Schedule: Full Time

Shift: Days

Hours Per Shift: 8 hr

JOB SUMMARY

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. Must be able to 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. Attends and participates in investigator meetings. Monitors enrollment goals and modifies recruitment plan as necessary.

POSITION RESPONSIBILITIES

Applies an assigned technique for critical thinking in a decision-making process. Maintains sense of commitment to success, personal achievement and satisfaction. Proceeds without seeking unnecessary permission. Creates realistic and attainable program of professional development for self. Develops clear, thorough schedules that deal with a variety of situations. Tracks the implementation of plans closely to ensure that desired outcomes are achieved. Resolves issues related to collaborative efforts in varying business conditions. Mediates and resolves conflicts among individuals, groups, and departments. Translates vision into specific functional or departmental initiatives. Carries out difficult interpersonal responsibilities professionally and effectively. Coaches others on clinical skills, knowledge and effective individualized patient care. Establishes and maintains effective working relationship with each team member.

DEPARTMENT DETAILS

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.

QUALIFICATIONS

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. Graduate from a nationally accredited nursing program preferred, including, but not limited to, Commission on Collegiate Nursing Education (CCNE), Accreditation Commission for Education in Nursing (ACEN), and National League for Nursing Commission for Nursing Education Accreditation (NLN CNEA).

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 1-877-673-0854 or send an email to talent@sanfordhealth.org .

City: Fargo

State: North Dakota

Job Function: Research

Job Schedule: Full Time

Shift: Days

Req Number: req26009

Company

Sanford Health is excited to be on a journey of tremendous growth and momentum. With our vast geography, cutting-edge medicine, sophisticated research, advanced education and our own health plan, we are unique in what we do and how we do it. Through relationships built on trust and successful performance and a vision to improve the human condition, Sanford seeks to make a significant impact on health and healing. With a commitment to diversity and inclusion, our journey as an organization includes continually building on the diverse talents, experiences and beliefs of our employees, as well as the patients and communities we serve. We are proud to be from the Midwest and to impact the world. We look forward to joining with you in the journey.

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