Senior Clinical Research Scientist
Cook Group
Traveling Clinical Research Coordinator – Vaccine Trial Experience Required
Alcanza Clinical Research
full-time
Posted on:
Location Type: Remote
Location: Remote • Florida • 🇺🇸 United States
Visit company websiteJob Level
Junior
Tech Stack
Google Cloud Platform
About the role
- Work to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs
- Collaborate with other members of the clinical research site team
- Screening of patients for study enrollment
- Patient consents
- Patient follow-up visits
- Documenting in source clinic charts
- Entering data in EDC and answers queries
- Obtaining vital signs and ECGs
- May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up
- Requesting and tracking medical record requests
- Updating and maintaining logs, chart filings
- Maintaining & ordering study specific supplies
- Scheduling subjects for study visits and conducts appointment reminders
- Building/updating source as needed
- Conducting monitoring visits and resolves issues as needed in a timely manner
- Ensuring study related reports and patient results are reviewed by investigator in a timely manner
- Filing SAE/Deviation reports to Sponsor and IRB as needed
- Documenting and reporting adverse events
- Reporting non-compliance to appropriate staff in timely manner
- Maintaining positive and effective communication with clients and team members
- Practicing ALCOAC principles with all documentation
- Assisting with study recruitment, patient enrollment, and tracking as needed
- Maintaining confidentiality of patients, customers and company information
- Performing all other duties as requested or assigned
- Complete all needed activities for study start-up, including completing required training
- Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed
- May set up, train and maintain all technology needed for studies
Requirements
- Medical Assistant diploma, LPN/LVN, EMT credential OR Associate’s degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and experience is required
- Vaccine trial experience required
- Proficiency with performing basic clinical procedures such as (blood pressure, vitals, EKGs, phlebotomy, etc.) is preferred
- Bi-lingual (English / Spanish) proficiency is a plus
- Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm)
- Strong organizational skills and attention to detail
- Well-developed written and verbal communication skills
- Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers
- Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities
- Must be professional, respectful of others, self-motivated, and have a strong work ethic
- Must possess a high degree of integrity and dependability
- Ability to work under minimal supervision, identify problems and implement solutions
- Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines
- May be required to travel up to 100% of the time, dependent on business needs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchblood specimen collectionphlebotomyvital signsECGsdata entryGCPICHHIPAAFDA Regulations
Soft skills
organizational skillsattention to detailwritten communicationverbal communicationinterpersonal skillsproblem-solvingadaptabilityself-motivationintegritydependability
Certifications
Medical Assistant diplomaLPN/LVNEMT credentialAssociate’s degree
