Clinical Research Coordinator (Contract)

About the Role

The Clinical Research Coordinator will manage the day-to-day operations of assigned clinical trials, ensuring adherence to pre-established work scope, study protocol, and regulatory requirements. This role involves recruiting and screening study participants, documenting and reporting on study operations, and tracking participant status. The ideal candidate will understand clinical trial priorities, establish efficient workflows, and handle confidential information with integrity. Strong communication, organizational skills, and a proactive, problem-solving mindset are essential. This position requires close collaboration with team members, pharmaceutical sponsors, and external vendors.

Responsibilities

• Exercise judgment within allowable limits defined by clinical trial protocols, standard operating procedures, and direction from study investigators and leadership.
• Maintain participant privacy and data confidentiality in compliance 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.
• Perform documentation and data management tasks in accordance with GCP and other regulatory guidelines.
• Act as a liaison with pharmaceutical sponsors and external vendors, participating in monitoring visits and audits.
• Manage participant engagement from recruitment to study completion, responding promptly to internal and external requests for information.
• Identify opportunities to improve participant care and satisfaction.
• Resolve study-related challenges collaboratively and within timelines set by supervisors.
• 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 protocols and study volume.
• Attend investigator meetings, pre-study site visits, study initiation visits, and other study-related visits hosted by monitors or sponsors.
• Track enrollment status and study-specific reports to ensure sites meet enrollment goals and maintain current information on site issues, deviations, and CRF status.
• 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 GED required; Bachelor’s Degree in a scientific field 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 or as applicable.
• Trained and certified in the administration of Fibroscan and memory screens (training provided).
• Basic Life Support (BLS) training (provided during onboarding).
• Valid Driver’s License.

Skills

• Strong organizational and time management skills, with the ability to track multiple projects simultaneously.
• Excellent written and oral communication skills.
• Knowledge of basic medical terminology.
• Ability to manage a high-volume workload with accuracy and compliance in a fast-paced team environment.
• Strong interpersonal skills, including the ability to interact with individuals from diverse backgrounds and handle confidential information discreetly.
• Positive, friendly, and professional demeanor, particularly when interacting with research participants.
• Ability to work independently and collaborate effectively with a team.
• Strong problem-solving and decision-making skills, especially under pressure.
• Proactive in identifying, addressing, and resolving issues in real time.
• Energetic self-starter with a results-oriented approach, able to thrive in an entrepreneurial environment.
• Proficiency in Spanish and English preferred.

Work Environment and Physical Demands

• Work is performed in an office, laboratory, and/or clinical environment.
• Exposure to biological fluids and/or bloodborne pathogens; personal protective equipment (e.g., eyewear, garments, gloves) is required.
• Occasional domestic and/or international travel may be required.
• 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.