Associate Clinical Research Coordinator - Part Time Evenings

Sanford Health•Marshfield, WI

25d•$21 - $33•Onsite

About The Position

Provides an opportunity to learn daily and contribute to treatments of the future under direction and guidance from leadership. Enthusiasm for learning required, along with participation in educating patients, physicians, nurses and other personnel about the research process. Under specific direction, assist other principal investigators and/or research team by performing basic clinical research duties following established protocols and research related support tasks. Work under direct supervision of a research manager and/or senior research staff (lead) while exhibiting good organizational, communication and interpersonal skills as well as time management. Assist and organize components of various clinical trials, including the coordination of study-required procedures, as well as investigational treatment for a variety of conditions and symptoms. Participate with direction in listing and clarifying questions and concerns with the investigator and sponsor regarding enrollment goals, sponsor expectations and study procedures. Assist with scheduling and coordinating pre-study site visits. Monitor enrollment goals and modify recruitment plan as necessary. Maintain patient screening/enrollment logs and appropriately update sponsors, contract research organizations (CROs) and/or senior medical officers (SMOs). Assure the completion of all screening, eligibility and enrollment procedures and data entry. Conduct interviews to assess subject ability and willingness to follow and complete study procedures and visits. Follow randomization procedures per protocol. Schedule subjects for follow-up visits. Review diaries and questionnaires completed by subjects. Ensure appropriate specimen collection, batching and shipping as required. Collect source documents for sponsor or audit review. Assess subject compliance. Abstract data from medical records, clinic, consultation and referral notes for preparation of study forms and flow sheets. Review inclusion/exclusion criteria to assure subject eligibility, and review with physician investigator for final sign-off. Review and verify required source documents in subject medical records to confirm study eligibility. Review study protocol, informed consent form and follow-up procedures with potential study subjects. Prepare case report forms for sponsor or audit review. Responsible for insurance pre-authorization for study participation, as applicable by study. Close collaboration with physician investigators required to ensure safe and compliant investigational treatment or intervention and follow-up per the established research protocol. Document and maintain all study-related procedures, processes and events by planning and designing new forms/source document tools to use in protocol implementation. Document protocol deviations and exemptions. Obtain and review original source documents as needed. Record accurate and timely data onto case report forms and into the trial data capture system. Maintain source documentation for all case report entries, as applicable. Key in data for electronic submission into the electronic data capture system. Correct and edit case report form entries as appropriate. Resolve data queries. Ensure drug/device accountability by completing appropriate documents per individual protocols. Schedule and participate in sponsor monitoring visits and audits to ensure compliance with regulatory requirements governing clinical research. Meet with monitors/auditors during routine visits to discuss case report form completion, query resolution and other protocol-related issues. Maintain clinical research department trial supply inventories including destruction of outdated materials, orders for restock and regular reporting of inventory counts to clinical research management. Occasional local travel between sites and student supervision may be required.

Requirements

Bachelor's degree in biology, microbiology or related field.
May consider graduates of an accredited school of practical nursing as a Licensed Practical Nurse (LPN) dependent on facility and department needs.
Minimum two years of clinical or clinical research experience or four to six years of relevant work experience required.
If a Licensed Practical Nurse (LPN), currently holds an unencur. LPN license with state nursing board and/or possess multi-state licensure privileges.
Obtains and subsequently maintains required department specific competencies and certifications.

Nice To Haves

Prior experience in the medical field or in research is a plus.

Responsibilities

Coordinating various aspects of clinical trials, including participant recruitment calls, screening and interviewing, scheduling study visits, and facilitating biospecimen collection.
Educating patients, physicians, nurses and other personnel about the research process.
Assisting other principal investigators and/or research team by performing basic clinical research duties following established protocols and research related support tasks.
Organizing components of various clinical trials, including the coordination of study-required procedures, as well as investigational treatment for a variety of conditions and symptoms.
Participating in listing and clarifying questions and concerns with the investigator and sponsor regarding enrollment goals, sponsor expectations and study procedures.
Assisting with scheduling and coordinating pre-study site visits.
Monitoring enrollment goals and modifying recruitment plan as necessary.
Maintaining patient screening/enrollment logs and appropriately updating sponsors, contract research organizations (CROs) and/or senior medical officers (SMOs).
Assuring the completion of all screening, eligibility and enrollment procedures and data entry.
Conducting interviews to assess subject ability and willingness to follow and complete study procedures and visits.
Following randomization procedures per protocol.
Scheduling subjects for follow-up visits.
Reviewing diaries and questionnaires completed by subjects.
Ensuring appropriate specimen collection, batching and shipping as required.
Collecting source documents for sponsor or audit review.
Assessing subject compliance.
Abstracting data from medical records, clinic, consultation and referral notes for preparation of study forms and flow sheets.
Reviewing inclusion/exclusion criteria to assure subject eligibility, and reviewing with physician investigator for final sign-off.
Reviewing and verifying required source documents in subject medical records to confirm study eligibility.
Reviewing study protocol, informed consent form and follow-up procedures with potential study subjects.
Preparing case report forms for sponsor or audit review.
Responsible for insurance pre-authorization for study participation, as applicable by study.
Collaborating with physician investigators to ensure safe and compliant investigational treatment or intervention and follow-up per the established research protocol.
Documenting and maintaining all study-related procedures, processes and events by planning and designing new forms/source document tools to use in protocol implementation.
Documenting protocol deviations and exemptions.
Obtaining and reviewing original source documents as needed.
Recording accurate and timely data onto case report forms and into the trial data capture system.
Maintaining source documentation for all case report entries, as applicable.
Keying in data for electronic submission into the electronic data capture system.
Correcting and editing case report form entries as appropriate.
Resolving data queries.
Ensuring drug/device accountability by completing appropriate documents per individual protocols.
Scheduling and participating in sponsor monitoring visits and audits to ensure compliance with regulatory requirements governing clinical research.
Meeting with monitors/auditors during routine visits to discuss case report form completion, query resolution and other protocol-related issues.
Maintaining clinical research department trial supply inventories including destruction of outdated materials, orders for restock and regular reporting of inventory counts to clinical research management.