Clinical Research Coordinator

PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship. For immediate consideration, please apply.

Kelly® Science & Clinical is seeking a Clinical Research Coordinator for a direct hire position at a leading client in Wheat Ridge, CO. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay Rate:

$60-75,000/Year (commensurate with experience)

Overview:

Our client is are seeking a dedicated and detail-oriented Clinical Research Coordinator to join their team. This role is integral to the successful execution of clinical trials, ensuring that all research activities are conducted in compliance with regulatory standards and Good Clinical Practice (GCP). The ideal candidate will have a strong background in clinical research and possess excellent organizational skills to manage various aspects of study coordination.

Schedule:

Monday – Friday, 1st/Day: Standard Hours

Responsibilities:

• Coordinate clinical research studies from start to finish, including study start-up, recruitment, screening, enrollment, treatment, follow-up, and close-out.
• Develop and maintain study documents, including study protocols, informed consent forms, case report forms, and study manuals.
• Obtain and maintain regulatory approvals, including Institutional Review Board (IRB) approvals and other required regulatory documentation.
• Screen and enroll eligible study participants according to study protocols and ensure that participants receive appropriate study treatments and follow-up care.
• Collect and manage study data using electronic data capture systems and ensure the accuracy and completeness of study data.
• Develop and maintain study databases, conduct quality control checks, and generate study reports as required.
• Work closely with study sponsors and other stakeholders to ensure the successful completion of clinical research studies.
• Train and supervise research staff, including research assistants and volunteers, and ensure compliance with study protocols and regulatory requirements.
• Communicate study progress and results to study sponsors, regulatory authorities, and other stakeholders.
• Participate in the development and implementation of new clinical research studies and initiatives.
• Coordinate study activities with other departments and external partners.
• Monitor study progress and works to identify research related issues and discrepancies when evident, and appropriately escalates to site manager, director, or investigator for resolution as needed.
• Ensure compliance with study protocols, GCP guidelines, and regulatory requirements.
• Train and supervise junior research staff as required.
• Assist with collecting training forms, collection and or preparation of essential documents and obtaining required signatures from all applicable research personnel for regulatory/essential documents throughout the duration of a study including, but not limited, to Food and Drug administration (FDA) form 1572, CV, professional licensure, financial disclosure form (FDF), and Institutional Review Board (IRB) submission forms.
• Communicate with study participants and their families to provide study-related information and to ensure study visit schedules are met.
• Adheres to standard operating procedures (SOP).
• Participate in study team meetings and attend required training and educational sessions.
• Maintain study supplies and equipment and ensure that they are stored and maintained in accordance with regulatory requirements.
• Trains under the guidance of direct supervisor and other site personnel to promote participation in research studies including mail-outs and other marketing programs as applicable.
• Assist with general managed site projects and workload sharing as assigned by direct supervisor.

Qualifications:

• Experience:

1. CCRC Preferred (but not required).
2. Bachelor or master’s degree in a health-related field such as biology, or public health preferred.
3. Proficient knowledge of GCP guidelines, regulatory requirements, and clinical trial operations > 4 years’ experience working in clinical research environment.

• Excellent organizational and communication skills.
• Ability to work independently and as part of a team.
• Strong organizational skills and attention to detail, with the ability to manage multiple tasks and priorities simultaneously.
• Excellent communication skills, with the ability to communicate effectively with study sponsors, regulatory authorities, research staff, and study participants.
• Proficient in the use of electronic data capture systems and database management tools.
• Ability to work independently and as part of a team in a fast-paced, deadline-driven environment.
• Willingness to learn new skills and take on new responsibilities as needed.

Benefits:

• 401(k).
• Dental insurance.
• Health insurance.
• Paid time off.
• Vision insurance.

What Happens Next:

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.