What We Do
Care Access is a unique, multi-specialty network of research sites that operates
as one connected team of physician investigators, nurse coordinators, and
operations managers.
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 Site Manager, RN, is responsible for overseeing the day-to-day activities at
the site under the direction of the Region Manager. The Site Manager, RN 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 Site Manager, RN, will manage the sites most
challenging protocols (therapeutic areas and study designs) and those with Key
Sponsors and CROs. The Site Manager, RN, conducts delegated clinical tasks and
monitoring of research participants in accordance with Good Clinical Practices
(GCP), ensuring protocol and regulatory compliance.
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What You'll Be Working On (Duties include but not limited to):
- Oversee the day to day activities (further defined below) at the site under
the direction of the Region Manager
- Monitor and mentor all levels of CRC, RNs and 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
- Prescreen study candidates
- Obtain informed consent per Care Access Research SOP .
- 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)
- Manage the sites most challenging protocols (therapeutic areas and study
designs) and those with Key Sponsors and CROs.
- Act as a primary point of contact in the therapeutic field for Care Access
Research
- Conducts delegated clinical tasks (RN specific) and monitoring of research
participants in accordance with Good Clinical Practices (GCP), ensuring
protocol and regulatory compliance.
- Clinical Tasks Include:
- Preparation and administration of Investigational Product (IP; study drug)
- Monitor participant for adverse reactions
- Perform phlebotomy and insert IV catheters
- Conduct delegated clinical procedures as required per protocol
- Prioritize activities with specific regard to protocol timelines
- Maintain adherence to Health Canada Division 5 regulations and ICH guidelines
in all aspects of conducting clinical trials.
- Collaborate with PI to review and assess protocol (including amendments) for
clarity, logistical feasibility, safety, inconsistencies, etc.
- 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.
- Maintain the blinding of all study products where required.
- Enter all Quality issues into QMS and report protocol deviations to sponsor
- 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
- Ensure recruitment activities are optimized and all sites in the region are
meeting their study enrollment goals
- Engage in continuous independent learning within the therapeutic area of
responsibility
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)
- Understanding of issues affecting clinical research in the identified
therapeutic area of expertise
- Ability and willingness to mentor and guide less experienced CRC as they
develop and gain experience in all therapeutic areas
- Ability to communicate and work effectively with a diverse team of
professionals
- Excellent organizational, prioritization and leadership skills and
capabilities with a strong attention to detail
- Excellent computer skills with demonstrated abilities using clinical trials
database, IVR systems, electronic data capture, MS word and excel
- Critical thinker and problem solver
- Excellent interpersonal skills, detailed 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
Certifications/Licenses, Education, and Experience:
- RN or LPN/LVN preferred
- Research Professional Certification- CRCC preferred
- Bachelor’s Degree preferred, or equivalent combination of education, training
and experience.
- A minimum of 5years experience as a Clinical Research Coordinator required
- Prefer 1 year of experience as a Care Access Research Clinical Research
Coordinator
- Recent phlebotomy experience required
Benefits (Canada Only)
- 6 weeks paid vacation annually
- Access to group health benefits plan for self and dependents
- Voluntary group RRSP retirement plan with matched contributions
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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 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.
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 currently is unable to sponsor work visas.
