Clinical Research Coordinator - 258779

Medix™; Boston (MA); In loco; USD 60.000 - 75.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, and vision insurance

Life insurance

Disability coverage

Health Savings Account (HSA) options

Retirement plan with employer matching

Supplemental insurance plans

Descrizione del lavoro

Medix Staffing Solutions, Inc. seeks a Clinical Research Coordinator to ensure compliant execution of assigned clinical studies.

You will screen patients, obtain informed consent, coordinate follow-up visits, and enter data into EDC while maintaining source records and regulatory documents. Responsibilities include handling adverse events reporting, maintaining study logs, coordinating with sponsors and monitors, and supporting regulatory and start-up activities.

Competenze

• Clinical research or related clinical experience required or equivalent combination.

Mansioni

• Screen patients for eligibility and enrollment.

Conoscenze

Microsoft Office

EHRs

Typing 40+ wpm

Communication

Organization

Teamwork

HIPAA compliance

Multitasking

Formazione

Medical Assistant diploma

LPN/LVN

EMT credential

Associate's degree or equivalent

Strumenti

EHR systems

Descrizione del lavoro

The Clinical Research Coordinator (CRC) is responsible for ensuring the successful execution of assigned clinical studies in compliance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, HIPAA, FDA regulations, and applicable standard operating procedures (SOPs).

Key Responsibilities

Working collaboratively with the clinical research site team, responsibilities may include, but are not limited to:

• Screen patients for study eligibility and enrollment.
• Obtain informed consent from study participants.
• Coordinate and conduct participant follow-up visits.
• Document study activities in source records.
• Enter study data into electronic data capture (EDC) systems and respond to data queries.
• Obtain vital signs and perform ECGs/EKGs.
• Perform basic protocol-required laboratory procedures, including blood specimen collection, centrifuge operation, specimen storage and shipment, specimen accountability, and courier coordination.
• Request and track medical records.
• Maintain study logs, regulatory documents, and participant charts.
• Order and manage study-specific supplies.
• Schedule participant visits and provide appointment reminders.
• Create and update study source documentation as needed.
• Support monitoring visits and resolve findings in a timely manner.
• Ensure study reports and participant results are reviewed by the Principal Investigator.
• Prepare and submit serious adverse event (SAE) and protocol deviation reports to sponsors and Institutional Review Boards (IRBs), as required.
• Document and report adverse events.
• Report protocol noncompliance to appropriate personnel.
• Maintain effective communication with study sponsors, monitors, investigators, participants, and internal team members.
• Assist with participant recruitment, enrollment, and retention efforts as needed.
• Maintain confidentiality of participant, sponsor, and organizational information.
• Complete study start-up activities, including required training and regulatory documentation.
• Prepare for and participate in Site Initiation Visits (SIVs), Investigator Meetings (IMs), and other study-related meetings.
• Set up, train on, and maintain study-related technology and equipment as needed.
• Perform other duties as assigned.

Qualifications

Minimum Qualifications

• Medical Assistant diploma, Licensed Practical/Vocational Nurse (LPN/LVN), Emergency Medical Technician (EMT) credential, or an Associate's degree with at least one year of clinical research or relevant clinical experience, or an equivalent combination of education and experience.
• Experience performing basic clinical procedures such as obtaining vital signs, ECGs/EKGs, and phlebotomy is strongly preferred.
• Bilingual English/Spanish skills are a plus.

Required Skills

• Proficiency with Microsoft Office, email, electronic health records (EHRs), web-based applications, and typing at approximately 40+ words per minute.
• Ability to perform basic clinical procedures, including blood pressure measurement, vital signs, ECGs/EKGs, and phlebotomy.
• Strong organizational skills with excellent attention to detail.
• Effective written and verbal communication skills.
• Strong interpersonal skills and the ability to work independently and collaboratively with research staff, investigators, participants, sponsors, and monitors.
• Ability to manage multiple priorities in a fast-paced environment.
• Professionalism, initiative, reliability, and a strong work ethic.
• High level of integrity, discretion, and dependability.
• Ability to identify issues and implement appropriate solutions with minimal supervision.
• Ability to handle confidential information in compliance with HIPAA and applicable privacy regulations.

Benefits may include:

• Medical, dental, and vision insurance
• Life insurance
• Short- and long-term disability coverage
• Health Savings Account (HSA) options
• Supplemental insurance plans
• Retirement savings plan with employer matching
• Additional benefits based on employment status and organizational policies

Equal Opportunity Employer

The employer is committed to providing equal employment opportunities to all applicants and employees. Employment decisions are made without regard to race, color, religion, sex, age, national origin, disability, veteran status, sexual orientation, gender identity or expression, genetic information, or any other status protected by applicable law.