Job Description

The Holden Comprehensive Cancer Center at the University of Iowa is seeking a Clinical Trials Research Associate to serve as a member of the Clinical Trials Research team to coordinate clinical oncology study activities: assist in the planning, delivery and evaluation of health care provided to research protocol patients; work closely with Clinical Research Coordinators in the collection of data and in close collaboration with multiple departments and offices, including the University Clinical Trials Office; maintain medical documentation, binders and files; manage data entry and electronic data systems for clinical research protocols and laboratory investigations currently being conducted within the Holden Comprehensive Cancer Center (HCCC) at The University of Iowa.

Duties To Include

60% list core duties

• Functions as a member of the Clinical Research Services team to plan, deliver, and evaluate the health care provided to research protocol patients.
• Assists in the design, development, execution and administration for protocols and clinical studies.
• Oversees operations of clinical research studies including the recruitment, screening, coordination and scheduling of subject participation and procedures as required by protocol.
• Obtains informed consent; educates study participants on the scope of study, schedule of events per clinical trial protocol and requirements of participation.
• Follows study participants; manages collection of data including maintaining records of patient visits/interviews, documentation of adverse events, and review of medication records. Provides documentation for physician review to ensure patients are screened and treated according to protocol.
• Documents medical histories, symptoms, vital signs, treatments and results for assigned patients according to research protocol; reviews results to ensure quality and accuracy of data gathered; communicates with physician to assist in eligibility determination.
• Monitors compliance, gathers and maintains data for pharmaceutical sponsored research trials, in-house trials and cooperative group studies; develops complex study materials; creates worksheets, treatment flow sheets and assorted tools to ensure accurate source documentation of protocol treatment procedures; triages telephone calls from patients and families to facilitate clinic visits for medical care/emergency care needs; assists in obtaining prescription medications; ensures follow up care is conducted in alignment with clinical trial protocol.
• Collaborates with departments of Radiology, Pathology, Pharmacy, Nursing, Holden Comprehensive Cancer Center, Clinical Research Unit and/or other departments participating in the clinical research to ensure multi-disciplinary patient safety approaches; conveys study specific objectives and requirements; develops communication tools as necessary.
• Enters patients on protocol, ensuring that all prerequisites have been completed and are within the required parameters.
• Serves as liaison to local physicians/hospitals to facilitate care of protocol patients when hospitalized at outside institutions; obtains documentation of the hospitalizations; provides notification to the Principal Investigator, Study Sponsor, and FDA as required per protocol.
• Performs critical analysis of literature relevant to the clinical trials.
• Educates faculty, staff and others about clinical research and methods employed in research studies; prepares educational materials for patients and other staff as needed to carry out protocol therapy.
• Selects, applies and tests standard methodologies, techniques and tools such as manuals, forms and questionnaires.
• Reviews all query reports and resolves all monitoring issues.

20% leadership

• Participates in the development of general goals for the Clinical Trials Support Services
• Ensures time, energy, learning opportunities, and actions are focused on creating a safe, fair and respectful work environment and improving the workplace
• Coaches others on clinical skills, knowledge, and effective individualized patient care.
• Assists in judging validity of data; makes recommendations; performs and interprets statistical analysis of data; prepares data for computer analysis; uses evaluation data to revise and implement change in close collaboration with the principal investigator

20% Educational Training & Compliances

• Comply with UI policies and procedures
• Maintain knowledge of departmental SOPs; ensure personal practice is in line with SOPs
• Attends protocol meetings and other University of Iowa Health Care and Study Sponsor meetings; participates on committees as appropriate
• Seeks professional development opportunities

Capacity

• Maintain primary coordination responsibilities of up to 5 studies actively recruiting patients
• Ability to enroll up to 16 new patients on trial in a calendar year

The department intends to hire for one position from either Clinical Trials Research Associate, requisition 26001280 or Clinical Trials Research Associate, requisition 26001281, based on the qualifications of the successful candidate. Please apply to the specific position for which you wish to be considered or both.

Supervision Received

This position will be supervised by the Clinical Coordination Manager

Supervision Exercised

May provide functional or administrative supervision; may mentor new staff under direction

UI Health Care Core Values (WE CARE)

W elcoming

We are welcoming to the community, partners, staff, and patients utilizing the collective strength of our people.

E xcellence

We achieve and deliver our personal and collective best in the pursuit of quality and accessible health care, education, and research.

C ollaboration

We collaborate with health care systems, providers, and communities across Iowa and the region as well within our UI community. We believe teamwork- guided by compassion- is the best way to work.

A ccountability

We behave ethically, act openly and with integrity in all that we do, taking responsibility for our actions.

R espect

We create an environment where every individual feels safe, valued, and respected, supporting the well-being and success of all members of our community.

E mpowerment

We commit to fair access to research, health care, and education for our community and opportunities for personal and professional growth for our staff and learners.

University of Iowa Health Care—recognized as one of the best hospitals in the United States—is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, quality health care and excellent service for our patients. Simply stated, our mission is: Changing Medicine. Changing Lives.®

Holden Comprehensive Cancer Center is Iowa’s only NCI-designated comprehensive cancer center. The NCI designation recognized our cancer center, and its research scientist, physicians, and other health care professionals, for their roles in advancing cancer research that impacts on our ability to prevent, detect and treat our patients with cancer. Not just a floor, or a building, or even confined to a single college. Holden Comprehensive Cancer Center coordinates all cancer-related research, education, and patient care by faculty from 41 departments and six colleges, as well as UI Clinics and UI Children’s Hospital.

Percent of Time: 100%

Work Schedule: Monday – Friday, Hours generally worked between 7:00am-5pm

Pay Grade: 5A

Benefits Highlights

• Regular salaried position located in Iowa City, IA
• Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans
• For more information about Why Iowa?, click here

Required Qualifications

• A Masters degree or equivalent combination of education and professional nursing experience.
• 2 years of experience in nursing and/or clinical research.
• Current valid Iowa Registered Nurse license.
• Excellent verbal, written and interpersonal communication skills
• Proficient in computer software applications
• Ability to organize and evaluate complex medical information and data
• Ability to communicate effectively in a team environment
• Ability to manage complex information with attention to detail and a high level of accuracy

Desirable Qualifications

• Experience with adult oncology patients
• Experience coordinating clinical research studies
• Knowledge of regulatory guidelines and procedures
• Clinical Research Coordinator Certification (SOCRA or ACRP)
• Experience working with Epic
• Experience working with OnCore Clinical Trials Management System
• Knowledge of University of Iowa policies, procedures and regulations

Application Process:

In order to be considered, applicants must upload a resume and cover letter (under submission relevant materials) that clearly address how they meet the listed required and desired qualifications of this position.

Job openings are posted for a minimum of 14 calendar days.

Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification.

References: Five professional references will be requested and required at a later step in the recruitment process

This position is not eligible for University sponsorship for employment authorization.

With additional questions, please reach out to Sarah Waldschmidt at sarah-waldschmidt@uiowa.edu

Additional Information

• Classification Title: Clinical/HC Research Associate
• Appointment Type: Professional and Scientific
• Schedule: Full-time
• Work Modality Options: On Campus

Compensation

• Pay Level: 5A

Contact Information

• Organization: Healthcare
• Contact Name: Sarah Waldschmidt
• Contact Email: sarah-waldschmidt@uiowa.edu

Job Tags

Full time, Work at office, Local area, Monday to Friday,

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