Clinical Research Coordinator

Winaxis LLC; Lewes (DE); On-site; USD 50,000 - 80,000; Full time

Benefits offered by this job

Competitive compensation and benefits package

Opportunity for professional development

Supportive and collaborative work environment

Job summary

Winaxis LLC in Lewes, Delaware, is seeking a dedicated Clinical Research Coordinator to manage all aspects of assigned clinical research studies. Your role will include recruiting and enrolling study participants, ensuring compliance with study protocols, and maintaining accurate documentation.

Ideal candidates will have a Bachelor’s degree in Life Sciences or a related field and thorough knowledge of clinical trial processes. The position offers competitive compensation and a supportive work environment for ongoing professional development.

Qualifications

• Thorough knowledge of clinical trial processes, GCP, ICH guidelines, and regulatory requirements.
• Ability to manage multiple studies and prioritize tasks effectively.

Responsibilities

• Coordinate and oversee all aspects of assigned clinical research studies.
• Recruit, screen, and enroll study participants.
• Conduct informed consent discussions and ensure proper documentation.
• Schedule study visits and perform follow-up assessments with participants.
• Collect, record, and maintain accurate source documentation and case report forms (CRFs).
• Ensure adherence to study protocols and institutional policies.
• Communicate effectively with investigators, sponsors, and regulatory authorities.
• Manage investigational product accountability and inventory.
• Support monitoring visits, audits, and inspections.
• Assist in report preparation and data analysis as required.

Skills

Attention to detail

Documentation accuracy

Organizational skills

Communication skills

Interpersonal skills

Proficiency with EDC systems

Proficiency with MS Office applications

Education

Bachelor’s degree in Life Sciences, Nursing, Healthcare, or related field

Job description

Mission

Our mission is to ensure the highest standards of patient care and scientific integrity in every study we conduct.

Key Responsibilities

• Coordinate and oversee all aspects of assigned clinical research studies.
• Recruit, screen, and enroll study participants in accordance with protocol requirements.
• Conduct informed consent discussions and ensure proper documentation.
• Schedule study visits and perform follow-up assessments with participants.
• Collect, record, and maintain accurate source documentation and case report forms (CRFs).
• Ensure adherence to study protocols, Good Clinical Practice (GCP), and institutional policies.
• Communicate effectively with investigators, sponsors, and regulatory authorities.
• Manage investigational product accountability and inventory.
• Support monitoring visits, audits, and inspections.
• Assist in report preparation and data analysis as required.

Required Skills & Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Healthcare, or a related field.
• Thorough knowledge of clinical trial processes, GCP, ICH guidelines, and regulatory requirements.
• Strong attention to detail, documentation accuracy, and organizational skills.
• Proficiency with EDC systems and MS Office applications.
• Excellent communication and interpersonal skills.
• Ability to manage multiple studies and prioritize tasks effectively.

Nice to Have

• Certified Clinical Research Coordinator (CCRC) credential.
• Experience with Phase I–IV clinical trials.
• Familiarity with IRB submissions and site initiation procedures.
• Prior experience in oncology, pharmaceuticals, or medical device studies.

What We Offer

• Competitive compensation and benefits package.
• Opportunity to contribute to impactful clinical research projects.
• Supportive and collaborative work environment.
• Ongoing professional development and certification support.