SiteBridge Research, Inc.
Clinical Research Coordinator - Contractor - Lansing, MI Part - Time
SiteBridge Research, Inc., Lansing, Michigan, United States, 48900
Overview
Clinical Research Coordinator - Contractor - Lansing, MI Part-Time role at SiteBridge Research, Inc. (Contractor) Location
The position is located in Lansing, Michigan and will be on-site. Job Type
This is an (1099) Independent Contractor position and is part-time to begin with, with potential to move into full-time based on study needs. Job Description
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Clinical Principal Investigator on multiple ongoing research studies. The CRC facilitates and coordinates daily clinical trial activities in collaboration with the site team, sponsors, and clinical monitors to ensure ICH/GCP compliance, site productivity, and timely completion of studies. This role focuses on the trusted physician/patient partnership from start to finish for every clinical trial conducted at the site and is key in transforming clinical research for participants. The CRC will perform site-specific activities to maintain operational excellence and ensure compliance with protocol procedures, data acquisition, and records management. The position reports to the Director, Clinical Site Development Operations and Study Management. Location & Responsibilities
Ensure clinical study compliance with local and federal laws and regulations according to ICH/GCP Guidelines Ensure study feasibility assessments for contracted sponsor-initiated studies Assist the Clinical/Site Ops Leads on set-up/start-up of research site to prepare for start-up and conduct of clinical trials Lead oversight of pre-study, site initiation, and close-out visits with sponsor or CRO Consult with Site Leads, sponsor, and CRO to determine best recruitment practices for site and trials Track study activities to ensure compliance with SOPs, protocols, and all related regulatory and institutional policies Arrange screening and recruitment of potential study participants by scheduling visits to establish informed consent and perform intake assessments per protocol Create and maintain essential documents and records related to the study Serve as a point of reference for study participants by answering questions and updating them on study progress Oversee inventory of equipment and supplies related to the study, including documentation, issue reporting, and ordering clinical supplies as needed Coordinate with laboratories and clinical investigators to ensure review and reporting of lab results Direct requests, collection, labeling, storage, or shipment of interventional products Ensure collection of specimens, questionnaire data, and input of data into electronic systems Monitor participant enrollment status for each study Act as primary contact for sponsors/CROs to schedule and coordinate site visits and inquiries Participate in Investigator Meetings, Site Trainings, and related seminars to update knowledge of clinical research Prepare or participate in quality assurance audits and inspections Provide regular updates to Site Clinical Investigator(s) and Clinical/Site Ops Leads on study progress related to recruitment and compliance Qualifications & Required Experience
Bachelor’s degree in a relevant life science discipline is preferred; RN (BSN) is preferred; certification as CCRC/CCRP is a plus; education exceptions may be made based on relevant clinical research experience Minimum 1 year of experience in clinical research; level determined by total years of clinical site/trials experience Excellent working knowledge of FDA and ICH GCP regulations and guidelines Strong preference for experience with late-phase and observational clinical research Experience managing clinical study and staff records (e.g., case report forms, drug dispensation records) Experience preparing advertising and educational materials and conducting recruitment campaigns Experience preparing trial-related documents (protocol worksheets, adverse event reports, IRB documents, manuals, progress reports) Experience identifying, reviewing, and reporting adverse events or protocol deviations to investigators or regulatory authorities Assessing risk factors in study protocols and data management Clinical and laboratory skills; phlebotomy and sample processing are a plus Detail-oriented with strong follow-through and problem-solving abilities Strong organizational and time management skills Ability to work independently and as part of a team; good understanding of medical terminology Ability to lift approximately 20 pounds and stand for extended periods Additional Qualifications
Strong project management skills including risk assessment and contingency planning Collaborative, customer-oriented mindset and strong communication skills Proficient with MS Office and standard computer programs Interpersonal and written/verbal communication skills Therapeutic experience aligned with primary protocols and site practices preferred Some travel may be required Pay Range
The combined pay range for this role is $28 - $36/hour. Title and salary will be based on assessment of skills and experience relevant to the role. Equal Opportunity
SiteBridge Research, Inc. is proud to be an Equal Opportunity Employer providing a work environment free of discrimination and harassment. We respect and empower each individual and value diverse cultures, perspectives, skills, and experiences. We celebrate diversity and do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability status, or any other protected characteristic. All employment decisions are based on business needs, job requirements, and individual qualifications and performance.
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Clinical Research Coordinator - Contractor - Lansing, MI Part-Time role at SiteBridge Research, Inc. (Contractor) Location
The position is located in Lansing, Michigan and will be on-site. Job Type
This is an (1099) Independent Contractor position and is part-time to begin with, with potential to move into full-time based on study needs. Job Description
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Clinical Principal Investigator on multiple ongoing research studies. The CRC facilitates and coordinates daily clinical trial activities in collaboration with the site team, sponsors, and clinical monitors to ensure ICH/GCP compliance, site productivity, and timely completion of studies. This role focuses on the trusted physician/patient partnership from start to finish for every clinical trial conducted at the site and is key in transforming clinical research for participants. The CRC will perform site-specific activities to maintain operational excellence and ensure compliance with protocol procedures, data acquisition, and records management. The position reports to the Director, Clinical Site Development Operations and Study Management. Location & Responsibilities
Ensure clinical study compliance with local and federal laws and regulations according to ICH/GCP Guidelines Ensure study feasibility assessments for contracted sponsor-initiated studies Assist the Clinical/Site Ops Leads on set-up/start-up of research site to prepare for start-up and conduct of clinical trials Lead oversight of pre-study, site initiation, and close-out visits with sponsor or CRO Consult with Site Leads, sponsor, and CRO to determine best recruitment practices for site and trials Track study activities to ensure compliance with SOPs, protocols, and all related regulatory and institutional policies Arrange screening and recruitment of potential study participants by scheduling visits to establish informed consent and perform intake assessments per protocol Create and maintain essential documents and records related to the study Serve as a point of reference for study participants by answering questions and updating them on study progress Oversee inventory of equipment and supplies related to the study, including documentation, issue reporting, and ordering clinical supplies as needed Coordinate with laboratories and clinical investigators to ensure review and reporting of lab results Direct requests, collection, labeling, storage, or shipment of interventional products Ensure collection of specimens, questionnaire data, and input of data into electronic systems Monitor participant enrollment status for each study Act as primary contact for sponsors/CROs to schedule and coordinate site visits and inquiries Participate in Investigator Meetings, Site Trainings, and related seminars to update knowledge of clinical research Prepare or participate in quality assurance audits and inspections Provide regular updates to Site Clinical Investigator(s) and Clinical/Site Ops Leads on study progress related to recruitment and compliance Qualifications & Required Experience
Bachelor’s degree in a relevant life science discipline is preferred; RN (BSN) is preferred; certification as CCRC/CCRP is a plus; education exceptions may be made based on relevant clinical research experience Minimum 1 year of experience in clinical research; level determined by total years of clinical site/trials experience Excellent working knowledge of FDA and ICH GCP regulations and guidelines Strong preference for experience with late-phase and observational clinical research Experience managing clinical study and staff records (e.g., case report forms, drug dispensation records) Experience preparing advertising and educational materials and conducting recruitment campaigns Experience preparing trial-related documents (protocol worksheets, adverse event reports, IRB documents, manuals, progress reports) Experience identifying, reviewing, and reporting adverse events or protocol deviations to investigators or regulatory authorities Assessing risk factors in study protocols and data management Clinical and laboratory skills; phlebotomy and sample processing are a plus Detail-oriented with strong follow-through and problem-solving abilities Strong organizational and time management skills Ability to work independently and as part of a team; good understanding of medical terminology Ability to lift approximately 20 pounds and stand for extended periods Additional Qualifications
Strong project management skills including risk assessment and contingency planning Collaborative, customer-oriented mindset and strong communication skills Proficient with MS Office and standard computer programs Interpersonal and written/verbal communication skills Therapeutic experience aligned with primary protocols and site practices preferred Some travel may be required Pay Range
The combined pay range for this role is $28 - $36/hour. Title and salary will be based on assessment of skills and experience relevant to the role. Equal Opportunity
SiteBridge Research, Inc. is proud to be an Equal Opportunity Employer providing a work environment free of discrimination and harassment. We respect and empower each individual and value diverse cultures, perspectives, skills, and experiences. We celebrate diversity and do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability status, or any other protected characteristic. All employment decisions are based on business needs, job requirements, and individual qualifications and performance.
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