Clinical Research Coordinator

Job Description

Job Description

Job Title: Clinical Research Coordinator

Job Description

The Clinical Research Coordinator I supports and implements clinical research studies under the direction of the Principal Investigator in accordance with Good Clinical Practice. This role ensures that all research activities uphold the highest standards of regulatory compliance and data integrity while promoting a safe, respectful, and productive environment for study participants. The coordinator also oversees the work of research staff assigned to the study and contributes to the overall quality and efficiency of the research program.

Responsibilities

• Maintain complete and accurate site regulatory files for all assigned clinical studies.
• Work directly with Institutional Review Boards (IRBs), including preparing and submitting initial applications, modifications, continuing reviews, and other required documentation.
• Prescreen, recruit, and screen patients for participation in clinical studies, ensuring eligibility criteria are accurately assessed.
• Execute the informed consent process in accordance with ICH and GCP guidelines, ensuring that participants fully understand the study and their rights.
• Create source documents and record study visits in source data according to ALCOA-CCC principles, ensuring accurate, legible, contemporaneous, original, and attributable data.
• Perform phlebotomy, process blood and urine specimens, and prepare and ship samples according to study protocol and laboratory manuals.
• Enter source data into electronic data capture (EDC) systems such as Medidata RAVE and respond to data queries in a timely and accurate manner.
• Perform vital signs, ECGs, and other protocol-required clinical assessments during study visits.
• Record adverse events and serious adverse events in accordance with sponsor guidance, maintaining timely follow-up to document resolution and outcomes.
• Monitor, dispense, and collect investigational product while maintaining detailed accountability and temperature logs, and promptly report any temperature excursions.
• Work within interactive response technology (IRT) systems to manage investigational product and subject randomization as required.
• Schedule, prepare for, and conduct study visits with sponsors and contract research organizations, including site selection visits (SSV), site initiation visits (SIV), interim monitoring visits (IMVs), and close-out visits (COV).
• Support the integrity of the research program by adhering to CFR, GCP, and internal policies, and by fostering a safe and productive environment for research subjects.
• Collaborate with the Principal Investigator and research team to resolve study-related issues and maintain high-quality study conduct.

Essential Skills

• Bachelors degree in science, psychology, or a related field, or an additional four years of relevant research experience in lieu of a degree.
• Thorough knowledge of Code of Federal Regulations (CFR) and Good Clinical Practice (GCP) principles.
• Minimum of 1 year of experience as a Clinical Research Coordinator on Phase IIII pharmaceutical clinical trials.
• Hands-on phlebotomy skills and ability to perform blood draws as required by study protocols.
• Proficiency with Microsoft Office Suite, specifically Excel, for data tracking and reporting.
• Experience working with IRBs, including submissions, modifications, and continuing reviews.
• Ability to execute informed consent processes in accordance with ICH and GCP guidelines.
• Competence in entering and managing data in electronic data capture systems such as Medidata RAVE.
• Ability to perform vitals, ECGs, and other protocol-mandated clinical assessments.
• Strong understanding of regulatory and clinical research processes, including documentation and reporting of adverse events.
• Ability to oversee and coordinate the work of research staff assigned to studies.
• Effective communication and organizational skills to manage multiple studies and deadlines.

Additional Skills & Qualifications

• GCP certification is preferred.
• IATA certification is preferred for handling and shipping biological samples.
• Experience or interest in nephrology clinical research is beneficial.
• Familiarity with ICH guidelines and broader clinical research regulatory frameworks.
• Ability to travel between clinical sites as needed.
• Strong attention to detail and commitment to maintaining data integrity and regulatory compliance.

Work Environment

This role is primarily based at a clinical research site in Hinsdale, with occasional travel to additional locations to provide coverage during vacation or sick time. The position is embedded in an active clinical environment where direct interaction with patients, investigators, and sponsors is routine. Work involves handling blood and urine specimens, performing clinical assessments, and using electronic data capture and IRT systems. Mileage reimbursement is available for travel to distant sites. The environment emphasizes adherence to Good Clinical Practice, patient safety, and high-quality data collection, with a professional dress code appropriate for a clinical and sponsor-facing setting.

This is a Contract to Hire position based out of Hinsdale, IL.

The pay range for this position is $31.00 - $36.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

This is a Contract to Hire position based out of Hinsdale, IL.

This position is anticipated to close on Oct 21, 2026.

This is a fully onsite position in Hinsdale,IL.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.