Clinical Research Coordinator

About the role

The Clinical Research Coordinator will manage the day-to-day operations of assigned clinical trials, ensuring that pre-established work scope, study protocol, and regulatory requirements are followed. This position is responsible for a broad range of duties involving confidential information, requiring strong communication, organizational skills, and a proactive, problem-solving mindset. The role reports directly to the Clinical Operations Manager.

Responsibilities

• Exercise judgement within allowable limits defined by clinical trial protocols, standard operating procedures, and direction from study investigators and management.
• Maintain participant privacy and data confidentiality, complying with FDA, ICH GCP, HIPAA, institutional review board determinations, and institutional policies.
• Complete study-directed assessments with participants, including informed consent, medical history, adverse events, Fibroscan, memory screen, test article handling, appointment scheduling, records review, treatment coordination, and collecting vital signs.
• Complete documentation and data management tasks in accordance with GCP and other regulatory guidelines.
• Function as a liaison with pharmaceutical sponsors and external vendors, participating in monitoring visits and audits.
• Manage participant engagement from recruitment to study completion, responding to internal and external requests for information promptly.
• Identify opportunities to improve participant care and satisfaction.
• Resolve study-related challenges with a solutions-oriented and collaborative mindset.
• Establish and maintain productive relationships with internal and external personnel to achieve high research standards.
• Coordinate multiple projects with competing priorities and deadlines based on clinical trial protocol directives and study volume.
• Attend investigator meetings, pre-study site visits, study initiation visits, and other study-related visits hosted by monitors or sponsor representatives.
• Track enrollment status reports to ensure study sites meet enrollment goals and maintain current study-specific status reports.
• Create memos, emails, and letters related to study activities, and maintain reports or spreadsheets as requested.
• Assist regulatory personnel in maintaining study documents and ensure electronic regulatory documents are saved and uploaded appropriately.
• Report safety information to regulatory agencies and perform quality checks on source documents.
• Assist with the Corrective and Preventive Action Plan (CAPA) process as needed.

Requirements

• High school diploma or general education degree (GED) required; Bachelor’s Degree in a scientific area of study preferred or equivalent combination of education, training, and experience.
• 1 year of experience as a Clinical Research Assistant or Coordinator; 1-2 years of experience in Clinical Research.
• Proficient in Microsoft Office applications and Clinical Research IO (CRIO) or equivalent CTMS.
• Strong knowledge of ICH/GCP guidelines; must complete GCP training before interacting with participants and recertify every 2 years.
• Trained and certified in the administration of Fibroscan and memory screens as required by the study portfolio (training provided).
• Basic life support (BLS) training (provided during onboarding).
• Valid Driver’s License.
• Proficient in Spanish and English preferred.

Skills

• Ability to manage a high-volume workload with multiple clinical trials while maintaining accuracy and compliance.
• Strong organizational and time management skills, with keen attention to detail and the ability to track multiple projects.
• Excellent written and oral communication skills, including the ability to interact with individuals from diverse backgrounds.
• Strong problem-solving and decision-making skills, particularly under pressure.
• Proactive at identifying, addressing, and solving issues in real time.
• Ability to work independently and collaborate effectively in a team environment.
• Knowledge of basic medical terminology and clinical research protocols.
• Positive, friendly, and professional demeanor, especially when interacting with research participants.
• Energetic self-starter, results-oriented, and able to work effectively in an entrepreneurial environment.

Work Environment

• Work is performed in an office, laboratory, and/or clinical environment; exposure to biological fluids and/or bloodborne pathogens may occur.
• Personal protective equipment (e.g., protective eyewear, garments, gloves) is required.
• Occasional travel may be required, domestic and/or international.
• Ability to work in an upright and/or stationary position for 6-10 hours per day.
• Frequent mobility required; occasional squatting, kneeling, or bending.
• Light to moderate lifting and carrying (or otherwise moving) objects, including medical equipment, with a maximum lift of 20-50 lbs.

Benefits

• 401k retirement plan.
• Medical, dental, vision, long-term disability, short-term disability, FSA, and life insurance.
• 3 weeks of paid time off.
• 14 paid company holidays.
• Scrub uniform voucher (specific positions apply).