Clinical Research Coordinator II (Must be Bilingual)
Care Access, Chattanooga, TN, United States
About Care Access
Care Access is working to make the future of health better for all. With programs like Future of Medicine and Difference Makers, we bring world‑class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
How This Role Makes a Difference
The
Clinical Research Coordinator ’s primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
How You’ll Make An Impact
Patient Coordination
Prioritize activities with specific regard to protocol timelines.
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
Maintain effective relationships with study participants and other Care Access Research personnel.
Balance protocol needs with patient experience; proactively address concerns.
Monitor quality metrics; prevent deviations; resolve queries quickly.
Interact in a positive, professional manner with patients, representatives, investigators and Care Access Research personnel and management.
Coordinate and attend pre‑study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
Mentor CRC I peers; provide onboarding and day‑to‑day guidance.
Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate).
Manage moderate complexity; mixed visit types, active IP and AE/SAE workflows.
Operate as solo CRC onsite.
Prescreen study candidates.
Obtain informed consent per Care Access Research SOP.
Complete visit procedures in accordance with protocol.
Perform basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
Discuss study medication, required procedures, eligibility criteria and impact on office flow with investigator and site staff.
Documentation
Record data legibly and enter in real time on paper or e‑source documents.
Accurately record study medication inventory, medication dispensation, and patient compliance.
Resolve data‑management queries and correct source data within Sponsor provided timelines.
Assist regulatory personnel with completion and filing of regulatory documents.
Assist in the creation and review of source documents.
Patient Recruitment
Assist with planning and creation of appropriate recruitment materials.
Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.
Actively work with recruitment team in calling and recruiting subjects.
Review and assess protocol (including amendments) for clarity, logistical feasibility.
Ensure that all training and study requirements are met prior to trial conduct.
Communicate clearly verbally and in writing.
Anticipate needs; propose solutions; manage change effectively.
Attend Investigator meetings as required.
Own studies; prioritize competing demands; mentor CRC I.
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords).
Expertise Required
Ability to understand and follow institutional SOPs.
Excellent working knowledge of medical and research terminology.
Excellent working knowledge of federal regulations and good clinical practices (GCP).
Operate independently for most study activities; escalates complex issues as needed.
Ability to communicate and work effectively with a diverse team of professionals.
Strong organizational, prioritization and leadership skills with strong attention to detail.
Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS Word and Excel.
Critical thinker and problem solver.
Friendly, outgoing personality; maintain a positive attitude under pressure.
High level of self‑motivation and energy.
Excellent professional writing and communication skills.
Manages stakeholder communications; facilitates visits and meetings.
Ability to work independently in a fast‑paced environment with minimal supervision.
Certifications / Licenses, Education & Experience
Bachelor’s Degree preferred, or equivalent combination of education, training and experience.
A minimum of 3 years prior Clinical Research Coordinator experience required.
Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator.
Recent phlebotomy experience required.
Licenses:
California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health.
Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners.
Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health.
Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health.
How We Work Together
Location
This is an on‑site position with regional commute requirements.
Travel
This role requires up to 10% travel; the length of travel will depend upon study requirements, staff needs, and company initiatives.
Type: regional (within 100 miles).
Physical Demands
Ability to use keyboards and other computer equipment.
Walking – 20%
Standing – 20%
Sitting – 20%
Lifting – 20% (up to 25 lbs); Over 25 lbs overhead.
Driving – 20%.
Benefits & Perks (US Full Time Employees)
Paid Time Off (PTO) and Company Paid Holidays.
100% Employer paid medical, dental, and vision insurance plan options.
Health Savings Account and Flexible Spending Accounts.
Bi‑weekly HSA employer contribution.
Company paid Short‑Term Disability and Long‑Term Disability.
401(k) Retirement Plan, with Company Match.
Relocation Support Provided.
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
Equal Opportunity Statement
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, 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.
We do not sponsor work visas.
Care Access is unable to sponsor work visas at this time.
Accommodation for Applicants
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
Mandatory Employer Disclosures
Notice to Illinois applicants:
Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants:
Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants:
Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants:
Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants:
Under Maryland law, an employer may not require or demand, as a condition of employment, prospective employment, or continued employment, that an individual submit to or take a lie detector or similar test. An employer who violates this law is guilty of a misdemeanor and subject to a fine not exceeding $100.
#J-18808-Ljbffr
Care Access is working to make the future of health better for all. With programs like Future of Medicine and Difference Makers, we bring world‑class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
How This Role Makes a Difference
The
Clinical Research Coordinator ’s primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
How You’ll Make An Impact
Patient Coordination
Prioritize activities with specific regard to protocol timelines.
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
Maintain effective relationships with study participants and other Care Access Research personnel.
Balance protocol needs with patient experience; proactively address concerns.
Monitor quality metrics; prevent deviations; resolve queries quickly.
Interact in a positive, professional manner with patients, representatives, investigators and Care Access Research personnel and management.
Coordinate and attend pre‑study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
Mentor CRC I peers; provide onboarding and day‑to‑day guidance.
Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate).
Manage moderate complexity; mixed visit types, active IP and AE/SAE workflows.
Operate as solo CRC onsite.
Prescreen study candidates.
Obtain informed consent per Care Access Research SOP.
Complete visit procedures in accordance with protocol.
Perform basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
Discuss study medication, required procedures, eligibility criteria and impact on office flow with investigator and site staff.
Documentation
Record data legibly and enter in real time on paper or e‑source documents.
Accurately record study medication inventory, medication dispensation, and patient compliance.
Resolve data‑management queries and correct source data within Sponsor provided timelines.
Assist regulatory personnel with completion and filing of regulatory documents.
Assist in the creation and review of source documents.
Patient Recruitment
Assist with planning and creation of appropriate recruitment materials.
Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.
Actively work with recruitment team in calling and recruiting subjects.
Review and assess protocol (including amendments) for clarity, logistical feasibility.
Ensure that all training and study requirements are met prior to trial conduct.
Communicate clearly verbally and in writing.
Anticipate needs; propose solutions; manage change effectively.
Attend Investigator meetings as required.
Own studies; prioritize competing demands; mentor CRC I.
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords).
Expertise Required
Ability to understand and follow institutional SOPs.
Excellent working knowledge of medical and research terminology.
Excellent working knowledge of federal regulations and good clinical practices (GCP).
Operate independently for most study activities; escalates complex issues as needed.
Ability to communicate and work effectively with a diverse team of professionals.
Strong organizational, prioritization and leadership skills with strong attention to detail.
Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS Word and Excel.
Critical thinker and problem solver.
Friendly, outgoing personality; maintain a positive attitude under pressure.
High level of self‑motivation and energy.
Excellent professional writing and communication skills.
Manages stakeholder communications; facilitates visits and meetings.
Ability to work independently in a fast‑paced environment with minimal supervision.
Certifications / Licenses, Education & Experience
Bachelor’s Degree preferred, or equivalent combination of education, training and experience.
A minimum of 3 years prior Clinical Research Coordinator experience required.
Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator.
Recent phlebotomy experience required.
Licenses:
California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health.
Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners.
Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health.
Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health.
How We Work Together
Location
This is an on‑site position with regional commute requirements.
Travel
This role requires up to 10% travel; the length of travel will depend upon study requirements, staff needs, and company initiatives.
Type: regional (within 100 miles).
Physical Demands
Ability to use keyboards and other computer equipment.
Walking – 20%
Standing – 20%
Sitting – 20%
Lifting – 20% (up to 25 lbs); Over 25 lbs overhead.
Driving – 20%.
Benefits & Perks (US Full Time Employees)
Paid Time Off (PTO) and Company Paid Holidays.
100% Employer paid medical, dental, and vision insurance plan options.
Health Savings Account and Flexible Spending Accounts.
Bi‑weekly HSA employer contribution.
Company paid Short‑Term Disability and Long‑Term Disability.
401(k) Retirement Plan, with Company Match.
Relocation Support Provided.
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
Equal Opportunity Statement
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, 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.
We do not sponsor work visas.
Care Access is unable to sponsor work visas at this time.
Accommodation for Applicants
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
Mandatory Employer Disclosures
Notice to Illinois applicants:
Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants:
Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants:
Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants:
Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants:
Under Maryland law, an employer may not require or demand, as a condition of employment, prospective employment, or continued employment, that an individual submit to or take a lie detector or similar test. An employer who violates this law is guilty of a misdemeanor and subject to a fine not exceeding $100.
#J-18808-Ljbffr