Medix™
Overview
The Clinical Research Coordinator I supports the execution of clinical research studies by coordinating day-to-day trial activities under guidance and supervision. This role ensures studies are conducted in compliance with approved protocols, Good Clinical Practice (GCP), ICH guidelines, and internal operating procedures.
This range is provided by Medix™. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
This role will start as a 90 day contract with potential to extend or become permanent based on performance and business needs.
Hours:
Monday - Friday 7am - 4pm
Responsibilities
Support the coordination and execution of assigned clinical trials in alignment with protocol requirements and regulatory standards.
Assist with all phases of study operations, including study start-up, vendor coordination, participant recruitment, visit scheduling, source documentation review, and protocol training.
Conduct study visits and ensure accurate, timely data collection, entry, and resolution of data queries.
Track, document, and report adverse events, serious adverse events, and protocol deviations in accordance with study requirements and internal procedures.
Support the implementation of protocol amendments and assist with study close-out documentation and reporting.
Carry out research-related administrative and operational activities to ensure assigned protocols are managed effectively.
Communicate professionally with internal teams, leadership, study participants, sponsors, CROs, and external partners.
Apply Good Documentation Practices (GDP) when collecting, correcting, and transferring study data to sponsor or CRO systems.
Maintain strict confidentiality of participant protected health information (PHI) and all sponsor and company confidential information.
Prioritize participant safety by ensuring timely follow-up and reporting of all safety events per protocol and SOPs.
Ensure study data is entered into sponsor databases accurately and within required timelines.
Assist with appropriate delegation, training, and documentation of study team responsibilities.
Prepare, maintain, and submit regulatory documentation to sponsors and Institutional Review Boards (IRBs) in accordance with protocol, GCP/ICH, and IRB requirements.
Conduct participant eligibility assessments, including telephone and in-person pre-screening activities.
Execute participant recruitment plans as outlined by the clinical research team.
Maintain awareness of study timelines, endpoints, required vendors, and target patient populations for assigned protocols.
Perform clinical procedures within scope of practice and training, such as medication preparation and administration, phlebotomy, ECGs, fibroscan, and laboratory processing.
Demonstrate respect for cultural diversity and inclusive practices when interacting with study participants and colleagues.
Perform additional duties as assigned.
Education & Experience
Bachelor’s degree with at least 1 year of relevant experience in the life sciences or clinical research field, or
Associate’s degree with a minimum of 2 years of relevant life sciences experience, or
High school diploma or technical certification with at least 3 years of relevant experience in the life sciences industry.
Licensure & Certifications
Phlebotomy certification, if required by state regulations.
Intramuscular medication preparation and administration certification, if required by state regulations.
Seniority Level Associate
Employment Type Contract
Job Function Research and Health Care Provider
Benefits
Medical insurance
Vision insurance
#J-18808-Ljbffr
This range is provided by Medix™. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
This role will start as a 90 day contract with potential to extend or become permanent based on performance and business needs.
Hours:
Monday - Friday 7am - 4pm
Responsibilities
Support the coordination and execution of assigned clinical trials in alignment with protocol requirements and regulatory standards.
Assist with all phases of study operations, including study start-up, vendor coordination, participant recruitment, visit scheduling, source documentation review, and protocol training.
Conduct study visits and ensure accurate, timely data collection, entry, and resolution of data queries.
Track, document, and report adverse events, serious adverse events, and protocol deviations in accordance with study requirements and internal procedures.
Support the implementation of protocol amendments and assist with study close-out documentation and reporting.
Carry out research-related administrative and operational activities to ensure assigned protocols are managed effectively.
Communicate professionally with internal teams, leadership, study participants, sponsors, CROs, and external partners.
Apply Good Documentation Practices (GDP) when collecting, correcting, and transferring study data to sponsor or CRO systems.
Maintain strict confidentiality of participant protected health information (PHI) and all sponsor and company confidential information.
Prioritize participant safety by ensuring timely follow-up and reporting of all safety events per protocol and SOPs.
Ensure study data is entered into sponsor databases accurately and within required timelines.
Assist with appropriate delegation, training, and documentation of study team responsibilities.
Prepare, maintain, and submit regulatory documentation to sponsors and Institutional Review Boards (IRBs) in accordance with protocol, GCP/ICH, and IRB requirements.
Conduct participant eligibility assessments, including telephone and in-person pre-screening activities.
Execute participant recruitment plans as outlined by the clinical research team.
Maintain awareness of study timelines, endpoints, required vendors, and target patient populations for assigned protocols.
Perform clinical procedures within scope of practice and training, such as medication preparation and administration, phlebotomy, ECGs, fibroscan, and laboratory processing.
Demonstrate respect for cultural diversity and inclusive practices when interacting with study participants and colleagues.
Perform additional duties as assigned.
Education & Experience
Bachelor’s degree with at least 1 year of relevant experience in the life sciences or clinical research field, or
Associate’s degree with a minimum of 2 years of relevant life sciences experience, or
High school diploma or technical certification with at least 3 years of relevant experience in the life sciences industry.
Licensure & Certifications
Phlebotomy certification, if required by state regulations.
Intramuscular medication preparation and administration certification, if required by state regulations.
Seniority Level Associate
Employment Type Contract
Job Function Research and Health Care Provider
Benefits
Medical insurance
Vision insurance
#J-18808-Ljbffr