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Clinical Research Coordinator

2 months ago

St Paul, United States Fairview Health Services Full time

Overview:

The Fairview Health and Wellness Hub, located in Saint Paul is looking for a Clinical Research Coordinator to help coordinate all aspects of clinical trials and research studies from protocol development through closeout.

The Clinical Research Coordinator will typically coordinate clinical trials of moderate-risk/complexity. This position is a learned professional responsible for troubleshooting and resolving problems independently and with appropriate research teams and research sources available. Responsible for interpretation, application of and compliance with Federal Regulations, Good Clinical Practice, and University and Clinical Partner policies as it relates to assigned protocols as well as application of subject matter knowledge.

This is a full time position. We offer a generous benefits package including medical, dental, paid time off, retirement options, tuition reimbursement, student loan repayment program, and more. Check out more of our benefits information here: www.fairview.org/noncontract

Responsibilities/Job Description:

(35%) Independently facilitates the successful implementation of research protocols in multiple settings.

? Develops and/or manages protocol implementation plans, establishing protocol priorities, assessing needs and identifying potential risks.

? Works with clinical research specialists (IRB, Financial Hub, Recruitment, service providers, etc.) to ensure start-up and implementation of clinical trial is achieved.

? Implements protocol from pre-initiation through study close out with an ongoing priority of subjects safety while mitigating subject risks.

? Applies the Federal Code of Regulations, GCP standards, ethical guidance (Belmont Report, Declaration of Helsinki) and University and/or Fairview policies in the conduct of clinical trials.

? Establishes collaborative relationships with research partners using effective communication, teaching/mentoring, and directing team members relative to their roles within the protocol.

? Manages accurate study data collection and entry adhering to HIPAA regulations, using charts, correspondence, electronic medical records and communication with other health care workers.

? Maintains proficiency with multiple electronic case report form databases.

? Works with study monitors on an ongoing basis to ensure data compliance and integrity.

? Successfully manages multiple protocols, working with multiple investigators.

? Identifies and reports protocol related Serious Adverse Event (SAE), Adverse Events (AE), protocol deviations, as required by federal regulations.

? Provides educational in-services to faculty, staff, clinical partners, etc, as needed.

(30%) Manages and coordinates subject participation in research protocols

? Successfully screens and recruits potential clinical trial subjects by pre-screening medical records, planning and facilitating data base searches, networking with internal/external partners and advertising.

? Independently coordinates the informed consent process as delegated.

? Applies clinical research knowledge, GCP standards, and federal code of regulations, clinical research laws, and ethics to inform independent decisions to solve problems or trouble-shoot issues for subjects participating in protocols.

? Provides consistent and clear communication with subject, Investigator(s) and the clinical care team to ensure protocol compliance and subject safety.

? Acts as a subject advocate.

(15%) Provides Professional Clinical Research Expertise to University Faculty Conducting Research

? Provides expertise and guidance to investigator(s) regarding protocol feasibility, potential conflicts of interest, regulatory compliance, resource options, subject population, timelines, and budget.

? Delegates and oversees the preparation of the Human Subjects Protection Program application, annual review, safety reports to meet federal and safety guidelines.

? Assumes responsibility for directing the proposed study through the channels required for research approvals; judiciously follows the proposed study until approvals are obtained.

? Manages, organizes and/or creates all essential documents, including regulatory files, source documents, study communications, drug/device accountability and required logs (training, monitoring site signature, etc.).

? Ensures adherence to the Federal Code of Regulations within the investigators clinical trial portfolio.

? Advises investigator(s) regarding study progress; provides updates on study issues.

? Informs the investigator(s) of any safety issues or subject problems.

? Communicates effectively with partners in research both internal and external to the University, such as the Sponsor, the Contract Research Organization, Fairview partners, and Regulatory authorities.

(20%) Other Duties

? Provides expertise and knowledge to guide research staff and colleagues.

? Participates in budget planning and preparation, recommends/changes in protocol budget.

? Develops and cultivates relationships with multiple departments within the institution to execute complex protocols.

? Educates, mentors, and guides undergraduate students in the field of clinical research.

? Utilizes project management skillset to intervene in project evaluation efforts in line with traditional quality improvement.

Qualifications:

Required

Education

BA/BS in health care, scientific or related plus at least 4 years of experience or advanced degree in health care, scientific or related plus 2 years of experience or a combination of related education and work experience to equal eight years

Preferred

Experience

Knowledge of navigating Electronic Medical Records - Epic