Location: Memphis, TN

  

Employment Type: Full Time - Regular

  

Team: Site Conduct

  

 **What We Do**

Care Access is a unique, multi-specialty network of research sites which
operates as one connected team of physician investigators, nurse coordinators,
and operations managers. Our goal is to engage every healthcare professional
in clinical research and to make clinical trials a care option for every
patient. 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 Lead CRC is responsible for overseeing the day-to-day activities at the
site under the direction of the Region Manager. The Lead CRC is responsible
for ensuring delivery of enrollment goals while maintaining adherence to FDA
regulations, ICH guidelines, and CARE SOPs in all aspects of conducting
clinical trials. The Lead CRC will also carry a full study load.



 ** _What You'll Be Working On_**

 **Duties include but not limited to:**

 ** **

 **Site Support Responsibilities:**

Primary point of contact for the site

Supports Key Sponsors and CROs

Manages some of the sites most challenging therapeutic areas and study designs

Able to monitor and mentor all levels of CRCs to ensure complete understanding
of Care Access processes, SOPs, and values, ensuring that they are successful
during their transition to more demanding opportunities and responsibilities

Assist Region Manager and Operational Compliance and Quality Assurance
Departments with all Care Quality and FDA audits

Develops and maintains CAPAs, when needed, with approvals from the Regional
Site Manager

Assume CTMS superuser status and assist others to ensure accuracy, compliance,
and quality input







 **Study Preparation:**

•        Ability to understand and follow institutional SOPs

•        Collaborate with PI to review and assess protocol (including
amendments) for clarity, logistical feasibility, safety, inconsistencies, etc.

•        Work closely with Central Teams 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 the development of recruitment plan and obtain a listing of
potential candidates to contact from the subject database

•        Actively work with the recruitment team in calling and recruiting
subjects

•        Attend Investigator meetings.

•        Coordinate and attend pre-study site visits, site initiation visits
and monitor visits with clinical staff and Sponsor/CRO representatives and
report summary to the Region Manager if they are not in attendance

•        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)

•        Work with Region Manager and PI to ensure timely responses to
feasibility questionnaires and scheduling of site evaluation visits

•        Keep Region Manager apprised of any study changes and all study-
related issues that affect the performance of the site and the revenue
generation

•        Work with Region Manager to identify and communicate staff needs

•        Ensure there are adequate supplies and equipment on site



 **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

•        Maintain organized files for blank source documents, patient charts,
CRFs, and supplies

•        Investigational Product Accountability: receive, inventory, dispense,
monitor patient compliance, and reorder as necessary. Document accountability
log and patient records. Temperature monitoring and compliance of IP storage
conditions.

•        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

•        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
the Care Access team in an ongoing fashion

•        Maintain effective relationships with study participants and other
Care Access personnel

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

•        Communicate clearly verbally and in writing

•        Accept accountability for actions and function independently

 **Study Visit Conduct:**

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

•        Collect and review medical records against study Inclusion/Exclusion
criteria

•        Obtain informed consent per Care Access SOP

•        Complete delegated visit procedures and ensure proper specimen
collection, processing, and shipment in accordance with the protocol

•        Review laboratory results, ECGs, and other test results (e.g. MRIs)
for completeness and alert values ensuring investigator review in a timely
fashion

•        Record adverse events (AEs) and Serious Adverse Events (SAEs) and
promptly notify the Principal Investigator, Sponsor, and Regulatory team
following all applicable guidelines

•        Schedule participants within visit windows, notify personnel as
needed for procedures, and integrate visits with existing schedules to
maximize efficient workflow and positive participant experience

 **Documentation:**

•        ALCOA-C: Record data legibly, in real-time on source documents; note
additional information that may assist with the 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

•        Accurately transcribe data to eCRF. Resolve data management queries
and correct source data timely

•        Enter all Quality issues into QMS and report protocol deviations to
sponsor

•        Work closely with Regulatory Team to ensure all documents are
uploaded into eReg system



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**

·       This is an on-site position with regional commute requirements.
Regularly planned travel within the region will be required as part of the
role.

·       Ability to work evenings and weekends as needed

·       Must have access to reliable transportation



 ** _What You Bring_**

 **Knowledge, Skills, and Abilities:**

Excellent working knowledge of medical and research terminology

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

Ability and willingness to mentor and train site staff

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

Excellent organization, prioritization, and leadership skills with strong
attention to detail

Excellent computer skills with demonstrated abilities using CTMS, eREG, IWRS
systems, electronic data capture, MS word, and excel

Critical thinker and problem solver

Excellent interpersonal skills, detail-oriented and meticulous

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 and as a team player working together towards common goals



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

- Bachelor’s Degree or equivalent professional experience 

-Research Professional Certification preferred

-A minimum of 5 years of Clinical Research Coordinator experience



 **Benefits (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

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.

