Sanford Health Clinical Research Specialist - Caladrius Trex Study in Fargo, North Dakota
Job Title: Clinical Research Specialist | Caladrius Trex Study | Fargo
State: North Dakota
Department : CALADRIUS TREX STUDY
Job Schedule: Full Time
Hours Per Shift: 8 hr
Involves a balance of clinical patient contact and data management. Ability to organize multiple components of various clinical trials to provide investigational treatment for a variety of conditions and symptoms. Critical thinking skills and autonomy are necessary to perform the daily tasks that are carried out in partnership with the physician investigators and other members of the research team. Learn daily and contribute to treatments of the future. Enthusiasm for learning as is participation in educating patients, physicians, nurses, and other personnel to the research process.
Will collect and integrate data regarding patients condition for review by the physician investigator. Participates in listing and clarifying questions and concerns with the investigator and sponsor regarding enrollment goals, sponsor expectations, and study procedures. Reviews inclusion/exclusion criteria to assure subject eligibility, and reviews with physician investigator for final sign-off. Reviews and verifies required source documents in subjects medical record to confirm study eligibility. Reviews study protocol, informed consent form, and follow-up procedures with potential study subjects. Prepares case report forms for sponsor or audit review. Collects source documents for sponsor or audit review. Assesses subject compliance with the test article and follow-up visits. Abstracts data from medical records, clinic, consultation and referral notes for preparation of study forms and flow sheets. Attends and participates in investigator meetings. Schedules and coordinates pre-study site visits. Monitors enrollment goals and modifies recruitment plan as necessary. Maintains patient screening/enrollment logs and appropriately updates sponsors, CROs and/or SMOs. Assures that all screening, eligibility and enrollment procedures are performed. Conducts interviews to assess the subjects ability and willingness to follow and complete study procedures and visits. Follows randomization procedures as per protocol. Schedules subjects for follow-up visits. Reviews diaries and questionnaires completed by subject. Ensures appropriate specimen collection, batching and shipping as required. Documents and maintains all study-related procedures, processes and events by planning and design of new forms/source document tools to be used in protocol implementation. Documents protocol deviations and exemptions. Obtains and reviews original source documents (e.g., recordings, scans, tests, procedure results) as needed. Records accurate and timely data onto case report forms. Maintains source documentation for all case report entries, as applicable. Keys in data for electronic submission, if applicable. Corrects and edits case report form entries as appropriate. Resolves data queries. Ensures drug/device accountability by completing appropriate documentation per individual protocols. . Maintains files of all study-related documentation. Participates in monitoring visits and audits by scheduling sponsor monitoring visits to ensure compliance with regulatory requirements governing clinical research. Meets with monitors/auditors during routine visits to discuss case report form completion, query resolution and other protocol-related issues.
Bachelor's Degree Required.
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 firstname.lastname@example.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 .
State: North Dakota
Job Function: Research
Job Schedule: Full Time
Req Number: req8593