Job Description

Job Title: Clinical Research Coordinator I, RNJob Description

The Clinical Research Coordinator I, RN is responsible for conducting delegated clinical tasks and monitoring research participants in alignment with Good Clinical Practices (GCP), ensuring adherence to protocol and regulatory compliance.

Responsibilities

• Coordinate patient activities and prescreen study candidates.

• Obtain informed consent per SOP guidelines.

• Complete visit procedures as outlined in the protocol.

• Train others and perform clinical procedures such as blood draws, vital signs checks, and ECGs.

• Review laboratory results and test outcomes for completeness, and ensure timely investigator reviews.

• Discuss study medication, required procedures, eligibility criteria, and office flow impacts with the Investigator and site staff.

• Prioritize tasks with respect to protocol timelines.

• Ensure compliance with FDA regulations and ICH guidelines in clinical trial conduct.

• Coordinate and attend pre-study, site initiation, and monitoring visits with clinical staff and representatives.

• Identify and report adverse events (AEs) and Serious Adverse Events (SAEs) promptly.

• Prepare and administer Investigational Product (IP) and monitor participants for adverse reactions.

• Perform phlebotomy and IV catheter insertion as required.

• Maintain records for Investigational Products per regulations and sponsor requirements.

• Ensure proper storage, security, and temperature for medications and investigational products.

• Document data accurately and enter it in real-time on paper or electronic source documents.

• Record study medication inventory, dispensation, and patient compliance accurately.

• Resolve data management queries and correct source data within sponsor timelines.

• Assist in regulatory document completion and filing.

• Assist in creating and reviewing source documents.

• Assist with planning and creating recruitment materials.

• Develop recruitment plans and contact potential candidates from the subject database.

• Work actively with the recruitment team in calling and recruiting subjects.

• Review and assess protocol for clarity and feasibility.

• Ensure all training and study requirements are met before trial conduct.

• Communicate clearly both verbally and in writing.

• Attend required Investigator meetings.

• Ensure adequate supplies are available for protocol initiation.

• Interact positively and professionally with patients, sponsor representatives, investigators, and personnel.

• Maintain effective relationships with study participants and research personnel.

Essential Skills

• Understanding and following institutional SOPs.

• Knowledge of medical and research terminology.

• Knowledge of federal regulations and Good Clinical Practices (GCP).

• Excellent phlebotomy skills.

• Effective communication and teamwork skills.

• Ability to work independently in a fast-paced environment.

• Strong organizational and computer skills.

• Ability to balance tasks with competing priorities.

• Critical thinking and problem-solving abilities.

Additional Skills & Qualifications

• RN license in good standing required.

• Phlebotomy and infusion experience required.

• Clinical Research Experience preferred.

• Minimum of 1 year of relevant work experience required.

• Recent phlebotomy experience required.

Work Environment

The work environment is an on-site clinic setting, where you will engage directly with research participants and clinical staff, utilizing a variety of technologies and equipment to conduct clinical trials.

Job Type & Location

This is a Permanent position based out of Lima, OH.

Pay and Benefits

The pay range for this position is $80000.00 - $80000.00/yr.

Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match

Workplace Type

This is a fully onsite position in Lima,OH.

Application Deadline

This position is anticipated to close on Dec 30, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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