Clinical Research Coordinator II

About the Role

The Clinical Research Coordinator II 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 role involves recruiting and screening study participants, documenting and reporting on daily study operations, and tracking participant status. The position requires understanding clinical trial priorities and establishing workflows to complete all required activities promptly. Strong communication, organizational skills, and a proactive, problem-solving mindset are essential. The role involves handling confidential information and collaborating closely with team members, pharmaceutical sponsors, and external vendors.

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.
• 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.
• Respond promptly to internal and external requests for information.
• Identify opportunities to improve participant care and satisfaction.
• Resolve study-related challenges collaboratively and within set timelines.
• 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 sponsor representatives.
• Track enrollment status reports to ensure study sites meet enrollment goals.
• Track study-specific status reports to maintain current information on site issues, deviations, and CRF status.
• Serve as a mentor/trainer for less experienced staff on general and study-specific issues.
• Create memos, emails, and letters related to study activities.
• Maintain reports and 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.
• Perform quality checks on source documents specific to the study.
• 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 area of study preferred or equivalent combination of education, training, and experience.
• 2-3 years of experience as a Clinical Research Coordinator or 3-4 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).
• Proficient in both Spanish and English.
• 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 interpret clinical research protocols.
• Strong problem-solving and decision-making skills, particularly under pressure.
• Proactive in identifying, addressing, and solving issues in real time.
• Ability to work independently and collaborate effectively within a team.
• Strong interpersonal skills, including the ability to interact with individuals from diverse backgrounds and handle confidential matters with discretion.
• Positive, friendly, and professional demeanor, especially when interacting with participants.
• Energetic self-starter, results-oriented, and able to work effectively in an entrepreneurial environment.

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.

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 (for specific positions).