Clinical Research Coordinator II - job 1 of 3

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’s primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.

What You'll Be Working On

Duties include but not limited to:

●      Ability to understand and follow institutional SOPs.

●      Review and assess protocol (including amendments) for clarity, logistical feasibility

●      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

●      Attend Investigator meetings as required.

●      Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.

●      Assist in the creation and review of source documents.

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

Study Management:

●      Prioritize activities with specific regard to protocol timelines

●      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.

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

●      Communicate clearly verbally and in writing.

Patient Coordination:

●      Prescreen study candidates

●      Obtain informed consent per Care Access Research SOP .

●      Complete visit procedures 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.

●      Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)

Documentation:

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

●      Accurately record study medication inventory, medication dispensation, and patient compliance.

●      Resolve data management queries and correct source data within sponsor provided timelines

●      Assist regulatory personnel with completion and filing of regulatory documents.

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. 

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 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.

●      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:

●      Bachelor’s Degree preferred, or equivalent combination of education, training and experience.

●      A minimum of 3 years prior Clinical Research Coordinator experience required

●      Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator  

●      Recent phlebotomy experience required

-Bilingual in Spanish-preferred

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 currently unable to sponsor work visas.

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.