Care Access
Overview
Join to apply for the Travel Clinical Research Coordinator role at Care Access. Care Access is building the future of health by bringing world-class research and health services directly into communities. We operate hundreds of research locations and mobile clinics worldwide to expand access to medical breakthroughs. To learn more about Care Access, visit www.CareAccess.com. How This Role Makes A Difference
The Travel Clinical Research Coordinator (CRC) uses Good Clinical Practices (GCP) to screen, enroll, and closely monitor clinical study subjects while ensuring protocol and regulatory compliance. The role supports a decentralized clinical research process, increases study workload capacity, and strengthens interactions with sites, sponsors, and CROs while representing Care Access positively to communities, sponsors, CROs, and study participants and their families. The Travel CRC is proficient in ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+. It is a mid-level position with the ability to perform duties independently with limited day-to-day guidance, and will be mentored by the CRC Lead, Site Manager, Senior Manager, and other clinical operations leaders. Responsibilities
Understand and follow institutional SOPs Review protocol, study manuals, and investigator drug brochure for clarity, feasibility, safety, and consistency Assist with training and study requirements prior to trial conduct; coordinate with PI, Regulatory, Start-up and Clinical Trial Managers Discuss study medication, procedures, eligibility criteria, and impact on clinic flow with management and site staff Assist in planning and creation of recruitment and marketing materials Develop recruitment plans and obtain candidate lists from internal databases as appropriate Recruit subjects in collaboration with the recruitment team Attend Investigator meetings and coordinate site visits and monitoring visits with staff and Sponsor/CRO representatives Assist in creation or review of protocol-specific source documents Determine facility, equipment, and vendor needs and availability Ensure supplies are available for protocol initiation and ongoing study maintenance Educate Assistant CRCs, research coordinators, and site staff on required tasks Integrate new trial load with existing workload while prioritizing protocol timelines and participant safety Maintain organized files for source documents, patient charts, CRFs, regulatory documents, and study supplies Handle Investigational Product accountability as appropriate; document in logs and patient records Collect and evaluate concomitant medications Collect, process, and ship biological specimens as directed Coordinate monitoring visits and teleconferences with study teams and sponsors/CROs Assist in creation or review of protocol-specific documentation Assess facility, equipment, and outsourcing needs and availability Ensure on-site supplies are adequate for protocol initiation and maintenance Educate site staff and sub-investigators on required tasks Coordinate trial activities with vacation or sick leave coverage Maintain adherence to FDA regulations and ICH guidelines Communicate sponsor updates, patient concerns, and trial management issues to Care Access teams Maintain positive relationships with study participants and Care Access personnel Demonstrate professional communication and independent work capability Prescreen candidates by telephone and assess inclusion/exclusion criteria Obtain informed consent per SOP and document revised ICF discussions Administer delegated study questionnaires when appropriate Review medical records with medically qualified team members Complete visit procedures and ensure proper specimen collection, processing, and shipment Train others and perform basic clinical procedures (e.g., blood draws, vitals, ECGs) Review laboratory results and other tests for completeness and timely investigator review Recognize adverse events (AEs) and serious adverse events (SAEs) and initiate safety monitoring as required Schedule patient visits within windows and coordinate with teams to maximize efficiency Dispense study medication per protocol or IVRS and educate patients on usage and adherence Monitor patient progress on study medication Document data accurately in source documents and CRFs/EDC; correct errors per SOP Maintain accurate medication inventories and dispensing logs; ensure timely IVRS confirmations Keep copies of prescriptions and ensure accurate transcription to CRF/EDC Resolve data management queries and correct source data as needed Record protocol exemptions and deviations with sponsor as appropriate Prepare Note(s)-to-File for patient charts and regulatory filing as necessary Print and file sponsor correspondence for regulatory filing Maintain copies of patient-specific correspondence in source charts Assist regulatory personnel with continuation/final review reports Perform other duties as assigned Qualifications
Excellent working knowledge of clinical trials, medicine, and research terminology Strong knowledge of federal regulations, GCP, GDP, and ALCOA-C+ Effective communication with diverse teams Strong organizational, prioritization, and attention to detail; leadership capabilities Solid computer skills with experience using clinical trials databases, IVR, EDC, MS Word, and Excel Proficiency with CTMS (e.g., CRIO, Clinical Conductor, Clinical Ink), EDC (e.g., Medidata, Oracle, Inform), ePRO/eConsent, and IWRS/IXRS Critical thinker and problem solver; ability to work independently Professional written and verbal communication; positive, proactive attitude Ability to work in a fast-paced environment with minimal supervision Certifications, Education, And Experience
BS in nursing, pharmacy, or related science; equivalent education considered RN or LPN preferred Research Professional Certification (CRCC) or exam eligibility preferred Minimum 3 to 4 years of Clinical Research experience Minimum 2 years of Clinical Research Coordinator experience; management level preferred How We Work Together
Location: Full-time temporary hourly role for 12 months from hire decision; travel up to 75% nationwide Travel models may include: two weeks on / one week off, temporary events (3–7 days), or weekly deployments (one week on, 2–5 days off) Deployments typically normalize to a 32–42 hour work week Diversity & Inclusion
We serve diverse cultures and communities worldwide. We strive for an inclusive culture where all backgrounds are valued and respected. We are an equal opportunity employer; all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access cannot sponsor work visas at this time. If you need accommodation to apply, please contact TalentAcquisition@careaccess.com Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries: Research Services Referrals increase your chances of interviewing at Care Access by 2x. Get notified about new Clinical Research Coordinator jobs in Boston, MA.
#J-18808-Ljbffr
Join to apply for the Travel Clinical Research Coordinator role at Care Access. Care Access is building the future of health by bringing world-class research and health services directly into communities. We operate hundreds of research locations and mobile clinics worldwide to expand access to medical breakthroughs. To learn more about Care Access, visit www.CareAccess.com. How This Role Makes A Difference
The Travel Clinical Research Coordinator (CRC) uses Good Clinical Practices (GCP) to screen, enroll, and closely monitor clinical study subjects while ensuring protocol and regulatory compliance. The role supports a decentralized clinical research process, increases study workload capacity, and strengthens interactions with sites, sponsors, and CROs while representing Care Access positively to communities, sponsors, CROs, and study participants and their families. The Travel CRC is proficient in ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+. It is a mid-level position with the ability to perform duties independently with limited day-to-day guidance, and will be mentored by the CRC Lead, Site Manager, Senior Manager, and other clinical operations leaders. Responsibilities
Understand and follow institutional SOPs Review protocol, study manuals, and investigator drug brochure for clarity, feasibility, safety, and consistency Assist with training and study requirements prior to trial conduct; coordinate with PI, Regulatory, Start-up and Clinical Trial Managers Discuss study medication, procedures, eligibility criteria, and impact on clinic flow with management and site staff Assist in planning and creation of recruitment and marketing materials Develop recruitment plans and obtain candidate lists from internal databases as appropriate Recruit subjects in collaboration with the recruitment team Attend Investigator meetings and coordinate site visits and monitoring visits with staff and Sponsor/CRO representatives Assist in creation or review of protocol-specific source documents Determine facility, equipment, and vendor needs and availability Ensure supplies are available for protocol initiation and ongoing study maintenance Educate Assistant CRCs, research coordinators, and site staff on required tasks Integrate new trial load with existing workload while prioritizing protocol timelines and participant safety Maintain organized files for source documents, patient charts, CRFs, regulatory documents, and study supplies Handle Investigational Product accountability as appropriate; document in logs and patient records Collect and evaluate concomitant medications Collect, process, and ship biological specimens as directed Coordinate monitoring visits and teleconferences with study teams and sponsors/CROs Assist in creation or review of protocol-specific documentation Assess facility, equipment, and outsourcing needs and availability Ensure on-site supplies are adequate for protocol initiation and maintenance Educate site staff and sub-investigators on required tasks Coordinate trial activities with vacation or sick leave coverage Maintain adherence to FDA regulations and ICH guidelines Communicate sponsor updates, patient concerns, and trial management issues to Care Access teams Maintain positive relationships with study participants and Care Access personnel Demonstrate professional communication and independent work capability Prescreen candidates by telephone and assess inclusion/exclusion criteria Obtain informed consent per SOP and document revised ICF discussions Administer delegated study questionnaires when appropriate Review medical records with medically qualified team members Complete visit procedures and ensure proper specimen collection, processing, and shipment Train others and perform basic clinical procedures (e.g., blood draws, vitals, ECGs) Review laboratory results and other tests for completeness and timely investigator review Recognize adverse events (AEs) and serious adverse events (SAEs) and initiate safety monitoring as required Schedule patient visits within windows and coordinate with teams to maximize efficiency Dispense study medication per protocol or IVRS and educate patients on usage and adherence Monitor patient progress on study medication Document data accurately in source documents and CRFs/EDC; correct errors per SOP Maintain accurate medication inventories and dispensing logs; ensure timely IVRS confirmations Keep copies of prescriptions and ensure accurate transcription to CRF/EDC Resolve data management queries and correct source data as needed Record protocol exemptions and deviations with sponsor as appropriate Prepare Note(s)-to-File for patient charts and regulatory filing as necessary Print and file sponsor correspondence for regulatory filing Maintain copies of patient-specific correspondence in source charts Assist regulatory personnel with continuation/final review reports Perform other duties as assigned Qualifications
Excellent working knowledge of clinical trials, medicine, and research terminology Strong knowledge of federal regulations, GCP, GDP, and ALCOA-C+ Effective communication with diverse teams Strong organizational, prioritization, and attention to detail; leadership capabilities Solid computer skills with experience using clinical trials databases, IVR, EDC, MS Word, and Excel Proficiency with CTMS (e.g., CRIO, Clinical Conductor, Clinical Ink), EDC (e.g., Medidata, Oracle, Inform), ePRO/eConsent, and IWRS/IXRS Critical thinker and problem solver; ability to work independently Professional written and verbal communication; positive, proactive attitude Ability to work in a fast-paced environment with minimal supervision Certifications, Education, And Experience
BS in nursing, pharmacy, or related science; equivalent education considered RN or LPN preferred Research Professional Certification (CRCC) or exam eligibility preferred Minimum 3 to 4 years of Clinical Research experience Minimum 2 years of Clinical Research Coordinator experience; management level preferred How We Work Together
Location: Full-time temporary hourly role for 12 months from hire decision; travel up to 75% nationwide Travel models may include: two weeks on / one week off, temporary events (3–7 days), or weekly deployments (one week on, 2–5 days off) Deployments typically normalize to a 32–42 hour work week Diversity & Inclusion
We serve diverse cultures and communities worldwide. We strive for an inclusive culture where all backgrounds are valued and respected. We are an equal opportunity employer; all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access cannot sponsor work visas at this time. If you need accommodation to apply, please contact TalentAcquisition@careaccess.com Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries: Research Services Referrals increase your chances of interviewing at Care Access by 2x. Get notified about new Clinical Research Coordinator jobs in Boston, MA.
#J-18808-Ljbffr