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Job Title: Clinical Research CoordinatorJob Description

The Clinical Research Coordinator is responsible for utilizing Good Clinical Practices (GCP) in the screening, enrolling, and monitoring of clinical research study subjects while ensuring protocol and regulatory compliance.

Responsibilities

+ Prioritize activities with specific regard to protocol timelines.

+ Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.

+ Maintain effective relationships with study participants and other research personnel.

+ Interact in a positive, professional manner with patients, sponsor representatives, and investigators.

+ Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.

+ Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor.

+ Prescreen study candidates.

+ Obtain informed consent per standard operating procedures.

+ Complete visit procedures in accordance with protocol.

+ Train others and complete basic clinical procedures, such as blood draws, vital signs, and ECGs.

+ Review laboratory results, ECGs, and other test results for completeness and alert values, ensuring investigator review in a timely fashion.

+ Discuss study medication, required procedures, eligibility criteria, and impact on office flow with Investigator and site staff.

+ Record data legibly and enter in real-time on paper or e-source documents.

+ Accurately record study medication inventory, medication dispensation, and patient compliance.

+ Resolve data management queries and correct source data within sponsor-provided timelines.

+ Assist regulatory personnel with completion and filing of regulatory documents.

+ Assist in the creation and review of source documents.

+ Assist with planning and creation of appropriate recruitment materials.

+ Assist in the development of recruitment plan and obtain a listing of potential candidates to contact from the subject database.

+ Actively work with the recruitment team in calling and recruiting subjects.

+ Review and assess protocol for clarity and logistical feasibility.

+ Ensure that all training and study requirements are met prior to trial conduct.

+ Communicate clearly verbally and in writing.

+ Attend Investigator meetings as required.

+ Ensure adequate supplies have arrived on-site for protocol initiation.

Essential Skills

+ Ability to understand and follow institutional SOPs.

+ Excellent working knowledge of medical and research terminology.

+ Excellent working knowledge of federal regulations and good clinical practices (GCP).

+ Ability to communicate and work effectively with a diverse team of professionals.

+ Strong organizational, prioritization, and leadership skills with strong attention to detail.

+ Strong computer skills with demonstrated abilities using clinical trials databases, IVR systems, electronic data capture, MS Word, and Excel.

+ Critical thinker and problem solver.

+ Friendly, outgoing personality; maintain a positive attitude under pressure.

+ High level of self-motivation and energy.

+ Excellent professional writing and communication skills.

+ Ability to work independently in a fast-paced environment with minimal supervision.

Additional Skills & Qualifications

+ Bachelor’s Degree preferred, or equivalent combination of education, training, and experience.

+ A minimum of 3 years prior Clinical Research Coordinator experience required.

+ Recent phlebotomy experience required.

Work Environment

The position is based in an on-site clinic environment where you will engage directly with patients, study participants, and research personnel. The work requires adherence to regulatory standards and involves collaboration with clinical staff and sponsor representatives. A positive and professional demeanor is essential in this fast-paced setting.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $75000.00 - $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 26, 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 [email protected] (%[email protected]) for other accommodation options.