Clinical Research Assistant, Nurse

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 Clinical Research Assistant, Nurse is an entry level research position.  This position is responsible for handling Investigational Products (IP) in accordance with study protocols, Good Clinical Practices (GCP), and all other applicable guidelines and regulations including Company Standard Operating Procedures.  The Clinical Research Assistant, Nurse will work closely with the Clinical Research Coordinator to complete participant visits. 

What You'll Be Working On

Duties include but not limited to:

Patient Coordination

·       Prescreen study candidates  

·       Obtain informed consent per Care Access Research SOP . 

·       Complete visit procedures in accordance with protocol. 

·       Collect, process and ship specimens as directed by protocol, under the direction of the CRC

- Schedule visits with participants, contact with reminders    

Conducts delegated clinical tasks (Nurse specific) and monitoring of research participants in accordance with Good Clinical Practices (GCP), ensuring protocol and regulatory compliance. 

Clinical Tasks Include:

·       Receive and properly store investigational products according to the study manual, study protocol, and/or instructions for use. 

·       Prepare pharmaceutical medications for administration including re-packaging and labeling, according to protocol requirements. 

·       Maintain medication and product inventory records including receipt, dispensing, labeling, accountability, and reconciliation of all study products. 

·       Maintain the blinding of all study products, where applicable

·       Maintain all safety standards within the Investigational Product room 

·       Maintain dispensing records in accordance with regulations and sponsor requirements.

·       Maintain proper storage and security conditions for all medications and investigational products.

·       Maintain records of equipment logs in accordance with SOPs; and clean and maintain all equipment and work areas, including sterilization as required.

Documentation

·        Record data legibly and enter in real time on paper or e-source documents  

·        Request study participant payments

·       Update all applicable internal trackers and online recruitment systems

·       Assist with query resolution  

·       Assist with administrative tasks such as copying, scanning, filing, mailing, emailing, etc.  

·       Assist with maintaining all site logs 

·       Assist with inventory and ordering equipment and supplies  

Patient Recruitment

·        Participate in recruitment and pre-screening events (may be at another location)

·        Identify potential participants by reviewing medical records, study charts and subject database    

·        Assist with preparation of outreach materials. 

·        Assist with recruitment of new participants by conducting phone screenings  

·        Request medical records of potential and current research participants  

·        Actively work with recruitment team in calling and recruiting subjects  

Other Responsibilities

- Interact in a positive, professional manner with patients/participants, sponsor representatives, Investigators and Care Access Research personnel and management.

- 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.

- Collaborate and communicate effectively with the Clinical Research Team regarding Investigational product preparation and administration.

- Attend and participate in meetings

- Comply with regulatory requirements, policies, procedures, & standards of practice. 

Scope of Role

·       Autonomy of Role: Work is performed under general supervision

·       Direct Reports: No

Physical Requirements

·        Physical demands associated with onsite duties include: 

-Walking-20%

-Standing-20%

-Lifting-20%

-Driving-20%

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. Overnight travel will be minimal (<10%).

-Type of travel required: Regional (within 100 miles)

What You Bring

Knowledge, Skills, and Abilities:

·       Ability to understand and follow institutional SOPs. 

·       Ability and willingness to work independently with minimal supervision 

·       Ability to learn to work in a fast-paced environment 

·       Excellent communication skills and a high degree of professionalism with all types of people

·       Excellent organizational skills with strong attention to detail 

·       A working knowledge of medical and research terminology 

·       A working knowledge of federal regulations, Good Clinical Practices (GCP) 

·       Critical thinker and problem solver 

·       Friendly, outgoing personality with the ability to maintain a positive attitude under pressure 

·       Contribute to team and site goals 

·       Proficiency in Microsoft Office Suite 

·       High level of self-motivation and energy

Certifications, Education, and Experience:

- Clinical Research Experience preferred

·        Experience mixing medications for intravenous administration preferred

·        Phlebotomy Experience and Proficiency Required

Licenses:

- Licensed Practical Nurse or Registered Nurse with a minimum of 1 year of recent experience required

·        License in good standing in the state to which you are applying required

Benefits (US Full-Time Employees Only)

·        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 

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.