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About the Role

The Clinical Research Coordinator will manage the day-to-day operations of assigned clinical trials, ensuring adherence to protocols and regulatory requirements. This role involves recruiting and screening participants, documenting study progress, and reporting on participant status. The position requires strong organizational and communication skills, a proactive approach to problem-solving, and the ability to manage multiple projects effectively.

Responsibilities

Manage day-to-day operations of assigned clinical trials, ensuring adherence to protocols and regulatory requirements.
Recruit and screen study participants.
Document and report on daily study operations and participant status.
Exercise judgment within defined limits for clinical trial protocols, SOPs, and directives.
Maintain participant privacy and data confidentiality, complying with FDA, ICH GCP, HIPAA, IRB, and institutional policies.
Complete study-directed assessments with participants, including informed consent, medical history, adverse events, and vital signs collection.
Perform documentation and data management tasks in accordance with GCP and regulatory guidelines.
Liaise 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 with a solutions-oriented mindset.
Establish and maintain productive relationships with internal and external personnel.
Coordinate multiple projects with competing priorities and deadlines.
Attend investigator meetings, site visits, and sponsor-related visits.
Track enrollment status reports to ensure study sites meet enrollment goals.
Track study-specific status reports for site issues, deviations, and CRF status.
Create memos, emails, and letters related to study activities.
Create and maintain reports and/or spreadsheets.
Assist regulatory personnel with study documents and electronic document uploads.
Report safety information to regulatory agencies.
Perform quality checks on study source documents.
Assist with the Corrective and Preventive Action Plan (CAPA) process.

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.
1 year of experience as a Clinical Research Assistant or Coordinator.
1-2 years of experience in Clinical Research.
Proficient in all 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 (training provided).
Basic life support (BLS) training required (provided during onboarding).
Demonstrated organizational skills and outstanding time management, with keen attention to detail.
Ability to track multiple projects simultaneously.
Strong written and oral communication skills.
Knowledge of basic medical terminology.
Possess integrity and personal and professional values consistent with company standards.
Comply with company policies, code of ethics, and guiding values.
Proficient in Spanish and English preferred.
Valid Driver’s License.
Ability to effectively communicate with all levels of internal and external contacts.
Demonstrated ability to manage a high-volume workload with multiple clinical trials while maintaining accuracy and compliance.
Ability to work independently and multitask in a fast-paced team environment.
Strong people skills, including the ability to interact with individuals from diverse backgrounds.
Ability to oversee confidential matters and sensitive information with discretion and judgment.
Positive, friendly, and professional demeanor, especially when interacting with research participants.
Ability to work independently and collaborate with a team.
Ability to interpret clinical research protocols.
Strong problem-solving and decision-making skills, particularly when under pressure.
Proactive at identifying, addressing, and solving issues in real time.
Energetic self-starter, results-oriented, and able to work effectively in an entrepreneurial environment.
Work is performed in an office/laboratory and/or a clinical environment.
Exposure to biological fluids and/or bloodborne pathogens.
Personal protective equipment 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.

Skills

Clinical Trial Management
Participant Recruitment and Screening
Data Management
Regulatory Compliance (FDA, ICH GCP, HIPAA)
Study-Directed Assessments
Communication (Written and Oral)
Organizational Skills
Time Management
Attention to Detail
Problem-Solving
Collaboration
Microsoft Office Suite
Clinical Trial Management System (CTMS)
Medical Terminology
Spanish Proficiency (Preferred)
Basic Life Support (BLS)
Fibroscan Administration
Memory Screen Administration

Location

Office/Laboratory/Clinical Environment

Work Type

Full-time

Experience Level

1 year of experience as a Clinical Research Assistant or Coordinator
1-2 years of experience in Clinical Research

Education Level

High school diploma or GED
Bachelor’s Degree in a scientific area of study preferred

Benefits

401k
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)

About the Company

Summit Clinical Research Solutions is an equal opportunity employer.

Equal Opportunity

All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status, or any other protected Federal, State/Province, or Local status unrelated to the performance of the work involved.