Clinical Research Coordinator I, RN
Marriottsville, MD
US Site Network – Site Operations /
Full Time - Regular /
On-site
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 CRC I, RN conducts delegated clinical tasks and monitoring of research participants in accordance with Good Clinical Practices (GCP), 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.
RN specific duties:
· Preparation and administration of Investigational Product (IP; study drug)
· Monitor participant for adverse reactions
· Communicate regularly with PI.
· Maintain a clean work area.
· Comply with Safety and PPE standards.
· Perform phlebotomy and insert IV catheters.
· Conduct delegated clinical procedures as required per protocol.
· Comply with regulatory requirements, policies, procedures, & standards of practice.
· Receipt and proper storage of investigational products
· Maintain Investigational Product records in accordance with regulations and sponsor requirements.
· Maintain the blinding of all study products where required.
· Maintain proper storage, security and temperature for all medications and investigational products.
Maintain appropriate research training and RN licensure in good standing
What You Bring
Knowledge, Skills, and Abilities:
· Working knowledge of medical and research terminology
· Working knowledge of federal regulations, good clinical practices (GCP)
· Excellent phlebotomy skills
· Ability to communicate and work effectively with a diverse team of professionals.
· Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals.
· Ability to work independently in a fast-paced environment with minimal supervision.
· 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
· 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:
A minimum of 1 year of relevant work experience required.
RN license in good standing required.
Phlebotomy and infusion experience required.
· Clinical Research Experience preferred.
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.
