Clinical Research Coordinator Assoc Pediatric Surgery

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Job ID

102533

Location

Aurora

Position Type

Regular

Regular / Temporary

Regular

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Job Overview

The Clinical Research Coordinator Associate is responsible for participating in the day-to-day operations of routine, minimally complex clinical research programs and / or studies conducted by Principal Investigators (PIs) at the University of Colorado Anschutz Medical Campus. Performs a variety of administrative and operational duties involved in the collection, compilation, documentation, and review of clinical research data. Supports the achievement of research program and / or study objectives. Works under close supervision, receiving instruction, guidance and direction from Senior CRC, Clinical Research Supervisor and / or leadership team.

Additional Information :

Hours per week : 24

Shift : M-F shifts will vary between 8 am to 5 pm.

Duties & Responsibilities

Documentation / Data Collection - Prepares and takes part in site initiation, monitoring, closeout visits, document storage activities, and related training. May assemble the necessary parties to ensure that all required agreements are in place. Utilizes and assists senior team members on electronic data capture systems, technologies, and software necessary for clinical research program and / or study operations. Scores tests, enters data, and completes required forms accurately and according to protocol. Assists with the development of data collection documents and instruments, maintains subject level documentation, and prepares documents, equipment and / or supplies identifies issues recommends solutions.

Regulatory - Submits assigned studies for review and approval and provides status updates throughout the startup process. Assists regulatory team with Institutional Review Board (IRB) preparation and submission.

Study Participation - Screens, schedules, consents participants in assigned clinical research programs and / or studies. With guidance, explains the difference between clinical activities and research activities, risk and benefits of study participation to participants. Engages with senior study team to maintain participant recruitment and retention rates and assists with participants with individual needs, collects information to determine feasibility. Collects information to determine feasibility, recruitment, and retention strategies. Collects, prepares, processes, ships, and maintains inventory of research specimens.

Protocol - Trains in developing protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Conducts and documents visits and testing / interviews according to all assigned regulatory and organizational protocols. Trains in completing and submitting AE reports, according to institution and sponsor-specific reporting requirements. Assists with the development of proposals or protocols as directed. Identifies and communicates related shortcomings. Maintains appropriate related documentation and tracks IP compliance at both protocol and subject level.

Human Subject Research Protection - Maintains compliance with institutional requirements and policies. Develops and maintains a familiarity with the ethical conduct of research and safeguards needed when conducting clinical research. Trains in the design of safeguards to ensure ethical conduct and to protect vulnerable populations and participates in sponsor required training. Trains on professional guidelines and code of ethics.

Team Coordination - Proactively includes others in decision making and escalates issues to leadership as necessary. Learns various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of clinical research program and / or study aims.

Quality Assurance - Investigates incomplete, inaccurate, or missing data / documents to ensure accuracy and completeness of data. Recognizes and reports vulnerabilities related to security of physical and electronic data. Assists with recognizing trends related to data quality and escalates as appropriate. Adheres to and participates in the development and assessment of quality assurance. Assists with identifying issues related to operational efficiency and shares results with team members.

Budgets / Financials - Participates in monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing.

Minimum Qualifications :

• Education : Bachelor's degree in a related field is required.
• Equivalency : High School diploma or GED, and four (4) years of clinical, clinical support, or clinical research related experience may be considered in lieu of minimum education requirement.

Salary Information

Pay is dependent on applicant's relevant experience.

Hourly Range : $21.35 to $32.00

Benefits Information

As a Children's Hospital Colorado team member, you will receive a competitive pay and benefits package designed to take care of your needs that includes base pay, incentives, paid sick leave and a robust wellness program.

As part of our Total Rewards package, Children's Colorado offers an annual employee bonus program that rewards eligible team members based on organizational performance. If organizational goals are met for the year, the bonus is paid out the following April.

Children's Colorado delivers annual base pay increases to eligible team members based on their performance over the previous year.

EEO Statement

It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law or regulation. Be aware that none of the questions are intended to imply illegal preferences or discrimination based on non-job-related information. The position is expected to stay open until the posted close date. Please submit your application as soon as possible as the posting is subject to close at any time once a sufficient pool of qualified applicants is obtained.

Colorado Residents : In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of attendance at or graduation from an educational institution. You will not be penalized for redacting or removing this information.