<p>Location: Sydney, Nova Scotia</p><br/><p>Employment Type: Full-time Employment</p><br/><p>Team: Clinical Research Coordinator (CRC)</p><br/><div><b style="font-size: 13pt">What We Do</b></div><div><span style="font-size: 12pt">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.</span></div><div><br></div><div><b style="font-size: 13pt">Who We Are</b></div><div><span style="font-size: 12pt">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.&nbsp;</span></div><div><br></div><div><b style="font-size: 13pt">Position Overview</b></div><div><span style="font-size: 12pt">The Clinical Research Coordinator conducts daily site operations according to CARE SOPs, GCP and FDA/ICH Guidelines.&nbsp;</span></div><div><br></div><div><b style="font-size: 13pt">What You'll Be Working On</b></div><div><span style="font-size: 12pt">Duties include but are not limited to</span></div><div><br></div><div><b style="font-size: 13pt">Study Preparation:</b></div><div><span style="font-size: 11pt">●</span><span style="font-size: 12pt"> Ability to understand and follow institutional SOPs</span></div><div><span style="font-size: 12pt">● Ability to perform all duties of Assistant CRC</span></div><div><span style="font-size: 12pt">● Learn to review and assess protocol (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc.</span></div><div><span style="font-size: 12pt">● Assist PI, Training Department, and the Trial Activation Manager(s) to ensure that all training and study requirements are met prior to trial conduct</span></div><div><span style="font-size: 12pt">● Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff</span></div><div><span style="font-size: 12pt">● Assist with planning and creation of appropriate recruitment materials</span></div><div><span style="font-size: 12pt">● Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database</span></div><div><span style="font-size: 12pt">● Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies</span></div><div><span style="font-size: 12pt">● Participate in Investigator meetings.</span></div><div><span style="font-size: 12pt">●Coordinate pre-study site visits with clinical staff and Sponsor/CRO representatives</span></div><div><span style="font-size: 12pt">● Assist in the creation or review of sponsor provided protocol specific source documents</span></div><div><span style="font-size: 12pt">● Determine facility, equipment and outsource vendor requirements and availability</span></div><div><span style="font-size: 12pt">● Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)</span></div><div><span style="font-size: 12pt">● Ensures that IRB approval is obtained prior to study initiation</span></div><div><br></div><div><b style="font-size: 13pt">Study Management:</b></div><div><span style="font-size: 12pt">●Integrate new trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines</span></div><div><span style="font-size: 12pt">● Maintain organized file for blank source documents, patient charts, CRFs and supplies</span></div><div><span style="font-size: 12pt">●&nbsp; Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records</span></div><div><span style="font-size: 12pt">● Collect and evaluate concomitant medication</span></div><div><span style="font-size: 12pt">●&nbsp; Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings</span></div><div><span style="font-size: 12pt">● Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave</span></div><div><span style="font-size: 12pt">● Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials</span></div><div><span style="font-size: 12pt">● 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</span></div><div><span style="font-size: 12pt">● Develop and maintain effective relationships with study participants and other care Access Research personnel</span></div><div><span style="font-size: 12pt">● Learn to interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management</span></div><div><span style="font-size: 12pt">● Communicate clearly verbally and in writing</span></div><div><span style="font-size: 12pt">● Accept accountability for actions and function independently</span></div><div><br></div><div><span style="font-size: 11pt">&nbsp;</span><b style="font-size: 13pt">Patient Coordination:</b></div><div><span style="font-size: 11pt">●</span><span style="font-size: 12pt"> Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment</span></div><div><span style="font-size: 12pt">● Obtain informed consent per Care Access Research SOP and document process when revised ICF discussed with patient during course of the trial</span></div><div><span style="font-size: 12pt">● Administer delegated study questionnaires</span></div><div><span style="font-size: 12pt">● Collect and evaluate medical records</span></div><div><span style="font-size: 12pt">●&nbsp; Complete visit procedures and ensure proper specimen collection, processing and shipment in accordance with protocol</span></div><div><span style="font-size: 12pt">● Be prepared to complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.</span></div><div><span style="font-size: 12pt">● Review laboratory results, ECGs, and other test results (e.g. MRIs) for completeness and alert values, ensuring investigator review in a timely fashion</span></div><div><span style="font-size: 12pt">● Learn to recognize adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator, Sponsor and regulatory coordinator Able to submit reportable events to IRB as required.</span></div><div><span style="font-size: 12pt">●Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol</span></div><div><span style="font-size: 12pt">● Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround</span></div><div><span style="font-size: 12pt">●Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance</span></div><div><span style="font-size: 12pt">● Monitor patient progress on study medication&nbsp;</span></div><div><br></div><div><b style="font-size: 13pt">Documentation:</b><span style="font-size: 11pt">&nbsp;</span></div><div><span style="font-size: 12pt">● 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</span></div><div><span style="font-size: 12pt">● 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</span></div><div><span style="font-size: 12pt">● Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart</span></div><div><span style="font-size: 12pt">●&nbsp; Accurately transcribe data to CRF. Resolve data management queries and correct source data as needed utilizing ALCOA-C principles</span></div><div><span style="font-size: 12pt">●&nbsp; Record protocol exemptions and deviations as appropriate with the sponsor. Complete Memo-to-File for patient chart and regulatory filing if necessary</span></div><div><span style="font-size: 12pt">● When necessary, help coordinate the creation of CAPA plans as required and ensure their full and timely execution</span></div><div><span style="font-size: 12pt">● Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing</span></div><div><span style="font-size: 12pt">● Maintain copies of patient-specific correspondence in source charts</span></div><div><span style="font-size: 12pt">● Assist regulatory personnel with completion of initial submission, continuing and final review reports</span></div><div><span style="font-size: 12pt">●Reports suspected non-compliance to supervisor 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.</span><span style="font-size: 14pt">&nbsp;&nbsp;</span></div><div><span style="font-size: 11pt">&nbsp;</span></div><div><b style="font-size: 13pt">Physical and Travel Requirements&nbsp;</b></div><div><span style="font-size: 12pt">Occasional planned travel may be required as part of the role.&nbsp;</span></div><div><br></div><div><span style="font-size: 13pt">What You Bring </span></div><div><span style="font-size: 12pt">Role Requirements:</span></div><div><span style="font-size: 12pt">Knowledge, Skills and Abilities:</span></div><div><span style="font-size: 11pt">●</span><span style="font-size: 12pt"> Good working knowledge of medical and research terminology</span></div><div><span style="font-size: 12pt">● Good working knowledge of federal regulations, good clinical practices (GCP)</span></div><div><span style="font-size: 12pt">● Ability to communicate and work effectively with a diverse team of professionals</span></div><div><span style="font-size: 12pt">● Excellent organizational skills with strong attention to detail</span></div><div><span style="font-size: 12pt">● Adequate computer skills with demonstrated abilities using MS word and excel</span></div><div><span style="font-size: 12pt">● Critical thinker and problem solver</span></div><div><span style="font-size: 12pt">● Friendly, outgoing personality with the ability to maintain a positive attitude under pressure</span></div><div><span style="font-size: 12pt">● High level of self-motivation and energy</span></div><div><span style="font-size: 12pt">● Excellent professional writing and communication skills</span></div><div><span style="font-size: 12pt">● Ability to work independently in a fast-paced environment with minimal supervision</span></div><div><br></div><div><span style="font-size: 12pt">Certifications/Licenses, Education, and Experience:</span></div><div><span style="font-size: 11pt">●</span><span style="font-size: 12pt"> BS in nursing, pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred</span></div><div><span style="font-size: 12pt">● Previous clinical research experience highly desired</span></div><div><span style="font-size: 12pt">●&nbsp; Active RN </span><span style="font-size: 16px">License </span><span style="font-size: 12pt">in the province of Nova Scotia, Canada. </span></div><div><span style="font-size: 11pt">&nbsp;</span></div><div><br></div><div><b style="font-size: 13pt">Diversity &amp; Inclusion</b></div><div><span style="font-size: 12pt">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.&nbsp;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.&nbsp;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.</span></div><div><br></div><div><span style="font-size: 12pt">Care Access is unable to sponsor work visas at this time.</span></div><div><br></div><div><br></div><div><br></div>

Location: Sydney, Nova Scotia

  

Employment Type: Full-time Employment

  

Team: Clinical Research Coordinator (CRC)

  

 **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**

The Clinical Research Coordinator conducts daily site operations according to
CARE SOPs, GCP and FDA/ICH Guidelines.

  

 **What You'll Be Working On**

Duties include but are not limited to

  

 **Study Preparation:**

● Ability to understand and follow institutional SOPs

● Ability to perform all duties of Assistant CRC

● Learn to review and assess protocol (including amendments) for clarity,
logistical feasibility, safety, inconsistencies, etc.

● Assist PI, Training Department, and the Trial Activation 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 office flow with Investigator and site staff

● 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 for
your studies and other site studies

● Participate in Investigator meetings.

●Coordinate pre-study site visits with clinical staff and Sponsor/CRO
representatives

● Assist in the creation or review of sponsor provided 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)

● Ensures that IRB approval is obtained prior to study initiation

  

 **Study Management:**

●Integrate new trial load with existing trial load, delegate tasks as
necessary, and prioritize activities with specific regard to protocol
timelines

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

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

● Collect and evaluate concomitant medication

●  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

● Develop and maintain effective relationships with study participants and
other care Access Research personnel

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

● Communicate clearly 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

● Collect and evaluate medical records

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

● Be prepared to 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

● Learn to recognize adverse events (AEs) and Serious Adverse Events (SAEs)
and promptly notify Principal Investigator, Sponsor and regulatory coordinator
Able to submit reportable events to IRB as required.

●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. Resolve data management queries and
correct source data as needed utilizing ALCOA-C principles

●  Record protocol exemptions and deviations as appropriate with the sponsor.
Complete Memo-to-File for patient chart and regulatory filing if necessary

● When necessary, help coordinate the creation of CAPA plans as required and
ensure their full and timely execution

● 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 initial submission,
continuing and final review reports

●Reports suspected non-compliance to supervisor 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  **

Occasional planned travel may be required as part of the role.

  

What You Bring

Role Requirements:

Knowledge, Skills and Abilities:

● Good working knowledge of medical and research terminology

● Good working knowledge of federal regulations, good clinical practices (GCP)

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

● Excellent organizational skills with strong attention to detail

● Adequate computer skills with demonstrated abilities using MS word and excel

● Critical thinker and problem solver

● Friendly, outgoing personality with the ability to 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

● Previous clinical research experience highly desired

●  Active RN License in the province of Nova Scotia, Canada.



  

 **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.

  

  

  

