Location: Brooklyn, NY

  

Employment Type: Full time - Temporary

  

Team: Clinical Delivery

  

 **What We Do**  

Care Access is delivering the future of medicine today! Care Access has a
revolutionary model that breaks down traditional barriers to clinical trials
that limit participation among physicians and patients to 3%. By removing this
bottleneck, Care Access is helping accelerate the approval and delivery of
critical and life-saving therapies.



 **Who We Are**  

We care. Our people are the engines behind our mission: to revolutionize
access to clinical trials for the benefit of patients everywhere. We care for
one another, find new ideas to accelerate medicine, and seed a long-term
impact for generations.  



 **Position Overview**  

Based out of Brooklyn, NY area, The Travel Clinical Research Coordinator
primary responsibilities are to utilize Good Clinical Practices (GCP) in the
process of screening, as well as enrolling and closely monitoring clinical
research study subjects while ensuring protocol and regulatory compliance. Due
to enhanced experience in Care Access’ decentralized clinical research
process, the Travel Clinical Research Coordinator will be able to assume a
greater study workload, overall study responsibility, and more detailed, Site,
Sponsor and CRO interactions, while conveying a positive image of Care Access
Research to the community, Sponsors, CROs, and study participants and their
family members.  



The Travel Clinical Research Coordinator is proficient at ICH/GCP, Good
Documentation Practices (GDP), and ALCOA-C+.  The Travel Clinical Research
Coordinator role is a mid-level position where the individual has strong
working knowledge and experience in the clinical research industry and can
perform their duties independently with little day to day guidance from their
managers. The Travel Clinical Research Coordinator will be mentored by their
CRC Lead, Site Manager, Senior Manager, and other leaders within clinical
operations.  



 **What You'll Be Working On**  

Duties include but not limited to:



 **Study Preparation:  **  

● Ability to understand and follow institutional SOPs  

● Review and assess protocol, study manuals, and the investigator drug
brochure (including amendments) for clarity, logistical feasibility, safety,
inconsistencies, etc.  

● Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure
that all training and study requirements are met prior to trial conduct  

● Discuss study medication, required procedures, eligibility criteria and
impact on clinic flow with your manager, Investigator, and site staff  

● Assist with planning and creation of appropriate recruitment and marketing
materials  

● Assist in development of recruitment plan and obtain listing of potential
candidates to contact from an internal subject database like StudyTeam, CRIO,
etc.

● Actively work with recruitment team in calling and recruiting subjects for
your studies and other site studies  

● Attend Investigator meetings as requested/required and/or coordinate/attend
pre-study site visits, site initiation visits and monitor visits with clinical
staff and Sponsor/CRO representatives  

● Assist in the creation or review of protocol specific source documents  

● Determine facility, equipment and outsource vendor requirements and
availability  

● Ensure adequate supplies have arrived on site for protocol initiation (lab
kits, study medication, specialized equipment, IVRS/EDC access and passwords)
and study maintenance

● Ensure education of Assistant CRCs, research assistants, site staff and/or
sub-investigators is completed for required tasks  

  

 **Study Management:   **

● Integrate new therapeutic, more complex trial load with existing trial load,
delegate tasks as necessary, and prioritize activities with specific regard to
protocol timelines and participant safety.

● Maintain organized file for source documents, patient charts, CRFs,
regulatory and study supplies  

● Where appropriate, Investigational Product Accountability: receive,
inventory, dispense, monitor patient compliance, and reorder as necessary.
Document on accountability log and patient records  

● Collect and evaluate concomitant medications  

● Collect, process, and ship biological specimens as directed by protocol
and/or laboratory manual.

● Integrate monitoring visits and study teleconferences into existing work
schedule to allow for adequate preparation and time for interaction during
meetings  

● Ensure trial activities are continuously discussed with covering personnel
in preparation of vacation or sick leave  

● Maintain adherence to FDA regulations and ICH guidelines in all aspects of
conducting clinical trials  

● Communicate sponsor updates, patient specific concerns/progress, unforeseen
issues, and overall trial management with appropriate members of Care Access
Research team in an ongoing fashion  

● Maintain effective relationships with study participants and other Care
Access Research personnel  

● Interact in a positive, professional manner with patients, sponsor
representatives, investigators and Care Access Research personnel and
management  

● Strong and clear communication skills, both verbally and in writing  

● Accept accountability for actions and function independently  



 **Patient Coordination:   **

● Prescreen study candidates by telephone and review exclusionary conditions
or medications prior to scheduling screening appointment  

● Obtain informed consent per Care Access Research SOP and document process
when revised ICF discussed with patient during course of the trial  

● Administer delegated study questionnaires, where appropriate.  

● Collect and evaluate medical records with the support of medically qualified
members of the study team.

● Complete visit procedures and ensure proper specimen collection, processing
and shipment in accordance with protocol  

● Train others and complete 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  

● Proficient at recognizing adverse events (AEs) and Serious Adverse Events
(SAEs)

● Ensure safety monitoring or symptomatic treatment is initiated as prescribed
or as specified in protocol  

● Schedule patients within visit windows, notify personnel as needed for
procedures and integrate visits with existing schedules to maximize efficient
workflow and patient turnaround  

● Dispense study medication per protocol and/or IVRS systems. Educate patient
on proper administration and importance of compliance.  

● Monitor patient progress on study medication  

  

 **Documentation:   **

● Record data legibly, in real time on source documents; note additional
information that may assist with causality of adverse events, explain protocol
deviations, or document patient progress. Correct errors per SOP  

● Accurately record study medication inventory, medication dispensation, and
patient compliance. Ensure accurate maintenance of dispensing logs and IVRS
confirmation is conducted in a timely fashion.  

● Maintain copies of all prescriptions written for study or non-study
medication or procedures in patient chart  

● Accurately transcribe data to CRF or EDC.  

● Resolve data management queries and correct source data as needed  

● Record protocol exemptions and deviations as appropriate with sponsor.  

● Complete **Note(s)-to-File** for patient chart and regulatory filing if
necessary  

● Ensure all sponsor correspondence (e-mail, telephone conversations) are
printed and given to appropriate personnel for regulatory filing  

● Maintain copies of patient-specific correspondence in source charts  

● Assist regulatory personnel with completion of continuing/final review
reports  

● Perform other duties as assigned.  



The duties and responsibilities listed above are representative of the nature
and level of work assigned and are not necessarily all-inclusive.  



 **Physical and Travel Requirements  **

Extensive travel required. Candidates must be willing to travel 75% of the
time nationwide, US based. Frequency and length of travel may depend on the
length and location of study.

  

●       Two weeks on / One week off deployments  

●       Temporary Event Support (3–7-day deployment durations)

●       Weekly deployments (one week on, 2-5 days off).  

●       Frequency and length of travel may depend on the length and location
of study, site, and event.

●       Deployments normalize to a 32 to 42-hour work week on average.



 **What You Bring**  



 **Knowledge, Skills, and Abilities:**  

● Excellent working knowledge of clinical trials, medicine and research
terminology  

● Excellent working knowledge of federal regulations, good clinical practices
(GCP), good documentation practices (GDP), and ALCOA-C+  

● Ability to communicate and work effectively with a diverse team of
professionals  

● Strong organizational, prioritization and leadership skills and capabilities
with a strong attention to detail  

● Strong computer skills with demonstrated abilities using clinical trials
database, IVR systems, electronic data capture, MS word, and excel.

● Proficiency with technology used to support the clinical trial industry.
CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like
MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc.

● 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  

● Ability to work independently in a fast-paced environment with minimal
supervision  



 **Certifications/Licenses, Education, and Experience:  **

● BS in nursing, pharmacy or other related science or combination of
equivalent education preferred in the Arts or Sciences preferred  

 **●** RN or LPN preferred  

 **●** Research Professional Certification- CRCC or exam eligibility preferred  

● A minimum of 3 to 4 years Clinical Research experience  

● A minimum of 2 years prior Clinical Research Coordinator experience,
management level

  

 **Benefits (Employment Contract – Full Time)**  

● PTO/vacation days, sick days, holidays.  

● 100% paid medical, dental, and vision Insurance. 75% for dependents.

● HSA plan

● Short-term disability, long-term disability, and life Insurance.  

● Culture of growth and equality

  

 **(US Full-Time Employees Only)**  

● PTO/vacation days, sick days, holidays.  

● 100% paid medical, dental, and vision Insurance. 75% for dependents.

● HSA plan

● Short-term disability, long-term disability, and life Insurance.  

● Culture of growth and equality

●  401k retirement plan

  

 **Diversity & Inclusion**

We serve patients and researchers from diverse cultures and communities around
the world. We are stronger and better when we build a team representing the
people we aim to support. We maintain an inclusive culture where people from a
broad range of backgrounds feel valued and respected as they contribute to our
mission. We value diversity and believe that unique contributions drive our
success.  



At Care Access, every day, we are advancing medical breakthroughs. We’re
uniting standard patient care with cutting-edge treatments and research. Our
work brings life-changing therapies to those in need and paves the way for
newer and greater treatments to reach the world. We’re proud to advance these
breakthroughs and work with the big players while engaging with the best
physicians and caring for patients.  



We are an equal opportunity employer, and all qualified applicants will
receive consideration for employment 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 is unable to sponsor work visas at this time.

  

 **Employment Statement**

Care Access complies with all employment laws and regulations with respect to
its employment practices, terms and conditions of employment, and pay equity
and wages. Care Access does not engage in any unfair or forced labor practice
and does not tolerate, under any circumstances, the use of any form of forced
or involuntary labor, child labor, or human trafficking. This extends to
suppliers, partners, or other third parties with whom Care Access does
business. Care Access values and promotes the protection of human rights
everywhere.



  

