Part Time Clinical Research Coordinator in Monroeville, Pennsylvania at SerenaGroup Inc

The Clinical Research Coordinator (CRC) at SerenaGroup plays a critical role in the execution of clinical trials focused on advanced wound care and hyperbaric medicine. This position is responsible for coordinating all aspects of clinical research studies, ensuring compliance with regulatory guidelines, and supporting high-quality patient care and data integrity throughout the study lifecycle.

The CRC will work collaboratively with Principal Investigators, Clinical Trial Leads, sponsors, and cross-functional teams to ensure studies are conducted efficiently, ethically, and in alignment with SerenaGroup’s commitment to evidence-based care and improved patient outcomes.

Key Responsibilities

Study Coordination & Execution

• Coordinate and manage day-to-day clinical trial activities from study start-up through close-out
• Schedule and conduct study visits in accordance with protocol requirements
• Ensure proper informed consent is obtained and documented for all study participants
• Maintain accurate and up-to-date study documentation, including regulatory binders and source documents

Patient Care & Engagement

• Identify, recruit, and screen eligible patients for clinical trials
• Educate patients on study protocols, procedures, and expectations
• Monitor patient safety and report adverse events in accordance with regulatory requirements

Data Management & Compliance

• Accurately collect, record, and enter study data into electronic data capture (EDC) systems
• Perform source data verification (SDV) and ensure data integrity and completeness
• Ensure compliance with FDA regulations, ICH-GCP guidelines, and SerenaGroup SOPs

Collaboration & Communication

• Serve as a liaison between investigators, sponsors, CROs, and internal teams
• Support monitoring visits, audits, and regulatory inspections
• Communicate effectively with cross-functional teams to ensure study milestones are met

Qualifications

Education & Experience

• Bachelor’s degree in life sciences, healthcare, or related field preferred
• 1–3 years of experience in clinical research or healthcare setting (wound care experience a plus)
• Experience working with clinical trial protocols and regulatory requirements preferred

Skills & Competencies

• Strong organizational and time management skills
• High attention to detail and accuracy in documentation
• Excellent interpersonal and communication skills
• Ability to manage multiple studies and priorities in a fast-paced environment
• Proficiency in EDC systems and Microsoft Office Suite

Preferred Qualifications

• Certification as a Clinical Research Coordinator (e.g., ACRP or SOCRA)
• Experience in wound care, hyperbaric medicine, or related therapeutic areas
• Familiarity with clinical trial start-up and regulatory submissions