- 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.
- Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
- Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
- 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.
- 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., 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.
- Comply with regulatory requirements, policies, procedures, & standards of practice.
- Maintain appropriate research training and RN licensure in good standing
- Working knowledge of federal regulations, good clinical practices (GCP)
- Excellent phlebotomy skills
- Bring positive and supportive attitude to achieving these goals.
- Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors.
- Bring positive and supportive attitude to achieving these goals.
- Strong computer skills
- Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done.
- Certifications/Licenses, Education, and Experience:
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Clinical Research Nurse Coordinator - Nova Scotia, Canada - Care Access
2 weeks ago
Description
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.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.
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.
Ensure that all training and study requirements are met prior to trial conduct.Study Management:
Current license with the Nova Scotia College of Nursing required.
Phlebotomy and infusion experience required.
Clinical Research Experience preferred - please include dates of completion any clinical trial certificates in GCP, TCPS2, CRAC on your CV.
·Benefits and Pension - We offer a competitive benefits and pension package for our Canadian employees.
Diversity & Inclusion
We serve patients and researchers from diverse cultures and communities around the world. 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.
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.#