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UnityPoint Health Research Regulatory Specialist in Cedar Rapids, Iowa

Description of Position:

Provide a “snapshot” or the principal purpose or focus of the position, consisting of no more than three to five sentences. This summary should provide enough information to differentiate the major function and activities of the position from those of other positions.

Research Regulations Specialist oversees the daily regulatory activities for research studies and coordinates and performs administrative research protocol support services. The Research Regulations Specialist assists in the creation, maintenance and utilization of study documents and databases containing clinical, financial, and other outcome data.

Essential Functions/Responsibilities:

Essential functions are the duties and responsibilities that are essential to the position (not a task list). Do not include if less than 5% of work time is spent on this duty. Be specific without giving explicit instructions on how to perform the task. Do not include duties that are to be performed in the future. Duties should be action oriented and avoid vague or general statements.

% of Time

(annually)

Key Accountability

· The associate is aware of hospital and department compliance for federally funded healthcare programs (e.g. Medicare and Medicaid) regarding fraud, waste and abuse. Brings any questions or concerns regarding compliance to the immediate attention of department or hospital administrative staff.

· Purposefully conducts all aspects of the job in an ethical manner in support of the hospital’s commitment to ethical behavior in all areas of personal and professional activity.

· Successfully completes hospital-wide orientation, annual hospital competencies and department/unit specific competencies.

· For the safety of our patients and co-workers, St. Luke’s Hospital requires seasonal and job-related vaccinations. This is reviewed regularly during periodic health assessments.

10 %

Key Accountability

· Coordinates and prepares documents for implementation of clinical trials including:

· Corresponds with various research organizations regarding the initiation of research studies and of related records; completes and submits documents as appropriate.

· Submission of appropriate Institutional Review Board forms and application materials.

· Organizes contract trial agreements, budgets and confidentiality disclosures for all studies.

· Responds to program correspondence, including inquiries and requests for protocol information.

· Publishes and distributes information to all study team members notifying them studies are open for enrollment, as well as distributing protocol amendments and study updates. Develops study summaries for sub-investigator education.

· Maintains internal and external databases as assigned.

· Apprises departmental personnel of any significant findings or problems identified during database maintenance or data submission.

· Complies with measure to maintain database security and confidentiality.

· Compiles accrual data for protocols, reviews and summarizes information for research team, Institutional Review Boards and local hospitals as needed for their reports.

· Prepares agenda for local IRB meetings to submit new studies, annual reviews, amendments and modifications.

40%

Key Accountability

· Maintains access to internal and external databases in accord with system or contractual requirements.

· Coordinates and prepares for monitoring visits for industry-sponsored studies and audits.

· Prepares necessary forms for the FDA Investigation of New Drug applications; submits Adverse Events and Safety Reports to Institutional Review Board; submits UI Laboratory Certification forms and all other regulatory request to sponsors and National Cancer Institute, submit detailed letters of correspondence to the Institutional Review Board.

· Assures appropriate routing procedures and signature approval requirements are met for industry and National Cancer Institute sponsored budgets and grants.

· As appropriate, develops and maintains tracking databases to assure timely reporting of required documents to regulatory bodies and study sponsors. Ensures accurate and timely data collection and entry into databases as indicated by department guidelines.

· Participates in the development, implementation and evaluation of policies and procedures.

· Facilitates cooperative formal and informal working relationships with inpatient and outpatient departments and medical staff as necessary.

· Demonstrates flexibility and self-direction in meeting patient and department needs by responding as a team player.

· Assists in the orientation of new associates by serving as a resource and mentor to associates.

· Assists in creating positive work environment that contributes to safety and positive outcomes.

40 %

Basic UPH Performance Criteria

· Demonstrates the UnityPoint Health Values and Standards of Behaviors as well as adheres to policies and procedures and safety guidelines.

· Demonstrates ability to meet business needs of department with regular, reliable attendance.

· Employee maintains current licenses and/or certifications required for the position.

· Practices and reflects knowledge of HIPAA, TJC, DNV, OSHA and other federal/state regulatory agencies guiding healthcare.

· Completes all annual education and competency requirements within the calendar year.

· Is knowledgeable of hospital and department compliance requirements for federally funded healthcare programs (e.g. Medicare and Medicaid) regarding fraud, waste and abuse. Brings any questions or concerns regarding compliance to the immediate attention of hospital administrative staff. Takes appropriate action on concerns reported by department staff related to compliance.

10%

Disclaimer: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

Demonstration of UPH Values and Standards of Behaviors

Consistently demonstrates UnityPoint Health’s values in the performance of job duties and responsibilities

Foster Unity:

· Leverage the skills and abilities of each person to enable great teams.

· Collaborate across departments, facilities, business units and regions.

· Seek to understand and are open to diverse thoughts and perspectives.

Own The Moment:

· Connect with each person treating them with courtesy, compassion, empathy and respect

· Enthusiastically engage in our work.

· Accountable for our individual actions and our team performance.

· Responsible for solving problems regardless of the origin.

Champion Excellence:

· Commit to the best outcomes and highest quality.

· Have a relentless focus on exceeding expectations.

· Believe in sharing our results, learning from our mistakes and celebrating our successes.

Seize Opportunities:

· Embrace and promote innovation and transformation.

· Create partnerships that improve care delivery in our communities.

· Have the courage to challenge the status quo.

Minimum Requirements

Identify items that are minimally required to perform the essential functions of this position.

Preferred or Specialized

Not required to perform the essential functions of the position.

Education:

Writes, reads, comprehends and speaks fluent English.

Baccalaureate degree required in field of health, science, math or related.

College course work in computers required or job-related training.

CCRP certification or equivalent preferred.

Experience:

Experience with use of Word, Excel, and PowerPoint and Access databases.

Experience with data entry required.

Ability to work independently and self-direct work activities.

Detail oriented and able to meet established deadlines.

Familiar with Institutional Review Board procedures.

Knowledge of medical terminology, specifically oncology, preferred.

Familiar with FDA regulations.

License(s)/Certification(s):

Valid driver’s license when driving any vehicle for work-related reasons.

Knowledge/Skills/Abilities:

Experience with Microsoft products required.

Ability to build positive working relationships with physicians and external agencies.

Ability to communicate with multiple levels of organizations and community (managers, physicians, clinical, and support staff).

Possesses a broad and varied knowledge base that is continually enhanced and updated through self-directed study and participation in educational opportunities, with experience/emphasis in IRB regulatory requirements desired.

Experience with database development and maintenance preferred.

Other:

Must demonstrate a cooperative, courteous, dependable working performance.

Must possess high integrity and maintain confidentiality at all times.

Promotes the cancer center’s philosophy of customer service and teamwork by possessing and demonstrating acceptable business etiquette.

Must contribute to a positive workflow in the department.

Requisition ID: 2020-78536

Street: 202 10th St SE

Name: 1010 UnityPoint Health CR St Lukes Hospital

Name: Helen G Nassif Comm Cancer

FTE (Numeric Only; Ex. 0.01): 0.8

FLSA Status: Non-Exempt

Scheduled Hours/Shift: Monday - Friday Days (32 Hours Per Week)

External Company URL: http://www.unitypoint.org

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