Investigational Product Preparer, Clinical Trials (Travel) at Care Access Research | Powderkeg

Location: Northern California

Employment Type: Contingent Contractor

Team: Prep Nurses

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 Investigational Product Preparer Nurse will have responsibility for preparing and packaging pharmaceutical investigational products in accordance with study protocols, Good Clinical Practices (GCP), and applicable guidelines and regulations including the Company’s Standard Operating Procedures.

What You'll Be Working On

Duties include but not limited to:

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

● Maintain Investigational Product (IP) inventory records including receipt, dispensing, labeling, accountability, and reconciliation.

● Maintain the blinded integrity of the clinical trial.

● Ensure the accuracy and integrity of products prior to their delivery to study participants.

● Maintain dispensing records in accordance with FDA regulations and sponsor requirements.

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

● Destroy and/or return IP per sponsor and site requirements.

● Maintains and adapts control methods and restrictions to pharmacy areas and all drug storage units.

● Coordinate routine maintenance and service needs for all pharmacy equipment; maintain records of equipment logs in accordance with SOPs; and clean and maintain all equipment and work areas, including sterilization as required.

● Collaborate and communicate effectively with the Clinical Research Team regarding study product preparation and administration.

● Attends and participates in meetings with the director, other managers, and staff.

● Complies with regulatory requirements, policies, procedures, and standards of practice.

Physical & Travel Requirements

· Extensive travel required. Candidates must be willing to travel regionally as well as nationwide if needed. Duties may require travel for a two-week stretch. Frequency and length of travel may depend on the length and location of study.

What You Bring

Role Requirements:

● Strength in communication and time management skills

● Experience participating in “Jumps” and all Investigational Product activities at Jump sites.

● Willingness to travel as needed, sometimes with less than a 24 hour notice.

Knowledge, Skills, and Abilities:

● Excellent working knowledge of medical and research terminology

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

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

● Strong organizational skills: Able to prioritize, delegate, direct, support, assign and evaluate others work and follow through on assignments.

● Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors.

● Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals.

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

● Ability to balance tasks with competing priorities.

● Critical thinker and problem solver

● Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done.

● Friendly, outgoing personality; maintain a positive attitude under pressure.

● High level of self-motivation and energy

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

● Must have a client service mentality.

Certifications/Licenses, Education, and Experience:

● Licensed Practical Nurse or Registered Nurse - Diploma, or equivalent.

● A minimum of 3 years of relevant work experience

● License in good standing

● CRC or Clinical Research Experience preferred.

● Experience in mixing of medications

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. We do not discriminate based on race, sex, religion, color, national origin, gender identity, age, marital status, veteran status, or disability status.

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. Our team of experts is paving the way to take this vision forward through innovation and a unique technology-enabled service model.

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.

Job Summary
  • Job Title
    Investigational Product Preparer, Clinical Trials (Travel)
  • Company
    Care Access Research
  • Location
    Rome, GA
  • Employment Type
    Full time
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