Clinical Research Coordinator

80037 Enterprise Corporate - Research Services

Full time

Yes

40

Hours tend to be standard and customary business hours. Work schedule may be flexed depending on the needs of patients and providers.

Pay Range

$30.70 - $46.05

Major Responsibilities

• Coordinates with Principal Investigator, Research Manager and other study personnel to ensure that clinical research and related activities are performed in accordance with ICH/GCP, federal regulations, sponsoring agency requirements, Advocate Health Navicent Medical Center policy and procedures and each study protocol.
• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
• Collects regulatory and other documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.). Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals.
• Assists PI in communication of study requirements to all individuals involved in the study. Participates in appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
• Conducts or participates in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended or revised consent forms are appropriately implemented and signed.
• Completes study documentation and maintains study files in accordance with sponsor requirements and hospital policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
• Maintains adequate inventory of study supplies. When handling investigational drugs/devices, follows the sponsor protocol, all applicable regulations and/or MCCG Policy on Investigational Drug/Device Accountability.
• Ensures each study participant is documented correctly in the billing system to ensure billing of study procedures to the appropriate funding source.
• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
• Collects regulatory and other documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.). Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals.
• Assists PI in communication of study requirements to all individuals involved in the study. Participates in appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
• Conducts or participates in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended or revised consent forms are appropriately implemented and signed.

MINIMUM JOB REQUIREMENTS

Education

Bachelor's degree

Certification / Registration / License

n/a

Work Experience

Research and Data Management experience

Knowledge / Skills / Abilities

• working knowledge of Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, and Access) and a wide variety of software applications.
• proficiency in the review and abstraction of clinical patient information from a medical record.
• mathematical ability necessary to validate and analyze data.
• excellent organizational skills; Detail-oriented; able to meet established deadlines.
• interpersonal skills necessary to interact effectively with physicians and other staff when gathering information.

PHYSICAL REQUIREMENTS AND WORKING CONDITIONS

Must be able to sit for prolonged periods of time. Must be able to lift and carry up to 10 pounds.Will be required to routinely visit patient care areas and may be required to wear personal protection equipment (mask, gloves, and/or gown).

Must have close visual acuity to perform activities such as: viewing electronic database and Electronic Medical Record (EMR) documentation; extensive reading of electronic and hard copy references; reviewing and analyzing data and figures.

PREFERRED JOB REQUIREMENTS

Education

Healthcare related bachelor's degree

Certification / Registration / License

Certification in clinical research (SoCRA, ACRP)

Knowledge / Skills / Abilities

• phlebotomy/venipuncture certification/skills
• familiarity of clinical information systems
• familiarity with REDCap software use

DISCLAIMER

All responsibilities and requirements are subject to possible modification to reasonably accommodate individuals with disabilities.

This job description in no way states or implies that these are the only responsibilities to be performed by an employee occupying this job or position. Employees must follow any other job-related instructions and perform any other job-related duties requested by their leaders.

Our Commitment to You:

Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including:

Compensation

• Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training
• Premium pay such as shift, on call, and more based on a teammate's job
• Incentive pay for select positions
• Opportunity for annual increases based on performance

Benefits and more

• Paid Time Off programs
• Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
• Flexible Spending Accounts for eligible health care and dependent care expenses
• Family benefits such as adoption assistance and paid parental leave
• Defined contribution retirement plans with employer match and other financial wellness programs
• Educational Assistance Program