CenterWatch

6 days old

Clinical Research Coordinator 2

The University of Chicago
Chicago, Illinois

Job Family

Research

Responsible for all aspects of research projects and research facilities. Plans and conducts clinical and non-clinical research; facilitates and monitors daily activities of clinical trials or research projects. Directs engineering and technical support activities to develop and maintain tools and computational methods needed to gather and analyze data.

Career Track and Job Level

Clinical Research

Manages, facilitates, and monitors the daily activities of clinical research and clinical trials. Performs a variety of duties involved in the collection, documentation, analysis and reporting of clinical research and clinical trial data. Manages the strategic, administrative, operational, and financial decisions that impact clinical research and clinical trials conducted across the University.

P1: Performs routine assignments in the entry level to a professional job progression. Typically requires a college or university degree or the equivalent work experience that provides knowledge and exposure to fundamental theories, principles and concepts. Develops competence by performing structured work assignments. Uses existing procedures to solve routine or standard problems. Receives instruction, guidance and direction from others.

Role Impact

Individual Contributor

Responsibilities

The job performs routine assignments related to the documentation, analysis, and reporting of research data. Provides input to support the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.

1) Performs various aspects of clinical research, such as collecting and processing specimens, interviewing subjects, taking vital signs, and contributing to the case report., 2) Analyzes protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics., 3) Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups., 4) Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports., 5) Performs other related work as needed.

Unit-specific Responsibilities

1) The Clinical Research Coordinator 2 (CRC) is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of a departmental or lab research manager.

2) While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC2 supports, facilitates and coordinates independently the daily clinical trial activities and plays a critical role in the conduct of the study.

3) By performing these duties with limited supervision and/or guidance, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

4) Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.

5) Recruit and interview potential study patients with guidance from PI and other clinical research staff.

6) Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.

7) Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.

8) Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.

9) Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.

10) Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.

11) Performs assessments at visits and monitors for adverse events.

12) Organizes and attends site visits from sponsors and other relevant study meetings.

13) Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.

14) Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.

15) Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.

16) Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.

17) Ensures compliance with federal regulations and institutional policies.

18) May prepare and maintain protocol submissions and revisions.

19) May assist in the training of new or backup coordinators.

Unit-preferred Competencies

1) Ability to be aware of safety hazards and take appropriate precautions.

2) Ability to communicate in writing.

3) Ability to communicate orally.

4) Ability to comprehend technical documents.

5) Ability to condense complicated issues to simple summaries that can be understood by a variety of constituents.

6) Ability to create and deliver presentations.

7) Ability to develop and manage interpersonal relationships.

8) Ability to exercise absolute discretion regarding confidential matters.

9) Ability to follow written and/or verbal instructions.

10) Ability to give directions.

11) Ability to handle sensitive matters with tact and discretion.

12) Ability to handle stressful situations.

13) Ability to learn and develop skills.

14) Ability to maintain a high level of alertness.

15) Ability to pay attention to detail.

16) Ability to perform multiple tasks simultaneously.

17) Ability to prioritize work and meet deadlines.

18) Ability to react effectively, quickly, calmly, and rationally during conflicts and emergencies.

19) Ability to read.

20) Ability to train or teach others.

21) Ability to work effectively and collegiality with little supervision or as member of a team.

22) Ability to work independently.

23) Ability to work with frequent interruptions.

Education, Experience, and Certifications

Minimum requirements include a college or university degree in related field.

Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.

 

Categories

Posted: 2019-05-15 Expires: 2019-06-14

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Clinical Research Coordinator 2

The University of Chicago
Chicago, Illinois

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast