Clinical Research Coordinator - 258779

Medix™; Boston (MA); On-site; USD 60,000 - 78,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with employer-m

Life insurance

Job summary

Medix™ is seeking a Clinical Research Coordinator to support successful execution of clinical trials at the research site. You will work with investigators, patients, sponsors and the research team to ensure protocols, GCP/ICH, HIPAA, FDA regulations, and SOPs are followed.

The role involves coordinating visits, obtaining informed consent, managing study data in EDC, performing vitals and basic lab procedures, and maintaining study documentation.

Qualifications

• Candidate must have Medical Assistant diploma/certificate, LPN/LVN license, or EMT credential plus at least 1 year of clinical or clinical research experience.
• Associate degree plus at least 1 year of clinical or clinical research experience.
• Hands-on experience with basic clinical procedures such as vital signs, blood pressure, ECGs, and phlebotomy is strongly preferred.
• Bilingual English/Spanish skills are a plus.

Responsibilities

• Coordinate day-to-day coordination and execution of assigned clinical research studies.
• Identify and screen potential participants according to study eligibility requirements.
• Guide participants through the informed consent process.
• Coordinate and conduct patient study visits and follow-up appointments.
• Enter study data into electronic data capture systems and address data queries.
• Obtain and document vital signs, ECGs, and other protocol-required assessments.
• Perform basic laboratory procedures, including blood draws, specimen processing, and shipment as required.

Skills

Microsoft Office

EHR systems

Attention to detail

Organization

Communication skills

HIPAA compliance

Bilingual English/Spanish

Education

Medical Assistant diploma/certificate/LPN/LVN EMT credential

Associate degree

Tools

EDC systems

Job description

We are seeking a Clinical Research Coordinator (CRC) to support the successful execution of clinical trials at the research site. This individual will work closely with investigators, patients, sponsors, and other members of the research team while ensuring study activities are conducted in accordance with applicable protocols, GCP/ICH guidelines, HIPAA requirements, FDA regulations, and internal SOPs.

Key Responsibilities

• Support the day-to-day coordination and execution of assigned clinical research studies.
• Identify and screen potential participants according to study eligibility requirements.
• Guide participants through the informed consent process.
• Coordinate and conduct patient study visits and follow-up appointments.
• Collect and accurately document clinical information in source records and study documentation.
• Enter study data into electronic data capture (EDC) systems and address data queries as needed.
• Obtain and document vital signs, ECGs, and other protocol-required assessments.
• Perform basic laboratory procedures, including blood draws, specimen processing, centrifugation, storage, packaging, and shipment when required by the study protocol.
• Coordinate medical record requests and monitor receipt of required documentation.
• Maintain study files, logs, trackers, and other essential research documentation.
• Monitor inventory levels and order study-specific supplies and materials.
• Schedule participant visits and conduct reminder calls or other outreach prior to appointments.
• Develop and maintain source documentation and study-specific materials as needed.
• Assist with monitoring visits and follow up on action items or findings in a timely manner.
• Ensure study reports, laboratory results, and other participant information are routed to the Investigator for appropriate review.
• Document and report adverse events, serious adverse events, protocol deviations, and other study issues according to applicable requirements.
• Escalate compliance concerns or non-compliance to the appropriate research personnel.
• Assist with participant recruitment, enrollment, retention, and tracking activities.
• Support study start-up activities, including required training, completion of certifications, and preparation of regulatory/site files.
• Assist with preparation for and participation in Site Initiation Visits (SIVs), Investigator Meetings, and other study-related meetings.
• Set up, maintain, and provide basic support for study-related technology and systems when needed.
• Maintain strict confidentiality of participant, client, and company information in accordance with HIPAA and applicable privacy requirements.
• Follow ALCOA/ALCOAC principles and maintain accurate, complete, and timely research documentation.
• Collaborate effectively with internal teams, investigators, sponsors, vendors, and study participants.
• Perform additional research-related responsibilities as assigned.

Minimum Qualifications

Candidates should meet one of the following:

• Medical Assistant diploma/certificate, LPN/LVN license, or EMT credential plus at least 1 year of clinical or clinical research experience; or
• Associate degree plus at least 1 year of clinical or clinical research experience; or
• An equivalent combination of education and relevant experience.\
• Hands-on experience with basic clinical procedures such as vital signs, blood pressure, ECGs, and phlebotomy is strongly preferred.
• Bilingual English/Spanish skills are a plus.

Desired Skills & Competencies

• Comfortable working with Microsoft Office, email, electronic health records, web-based applications, and other computer systems.
• Strong attention to detail and excellent organizational skills.
• Ability to accurately document and manage multiple study-related tasks simultaneously.
• Strong written, verbal, and interpersonal communication skills.
• Comfortable interacting with patients, investigators, coworkers, sponsors, and other external partners.
• Able to prioritize competing responsibilities and adapt to changing study needs.
• Self-motivated, dependable, professional, and able to work independently with limited supervision.
• Strong problem-solving skills and the ability to identify issues and take appropriate action.
• High level of integrity when handling confidential and sensitive information.
• Ability to maintain patient privacy and comply with HIPAA requirements.
• Proficiency with typing and general computer applications; 40+ words per minute preferred.

Full-time employees regularly scheduled to work 30 or more hours per week are eligible for benefits beginning the first day of the month following their date of hire.

Benefits may include:

• Medical, dental, and vision insurance
• Life insurance
• Short- and long-term disability coverage
• Health Savings Account options
• Supplemental insurance programs
• 401(k) retirement plan with safe harbor matching