Clinical Research Coordinator II

Alcanza Clinical Research•Fredericksburg, VA

38d•Onsite

About The Position

Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations across multiple states and Puerto Rico. We specialize in Phase I-IV studies in various therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. The Clinical Research Coordinator II, under the direction of the Site Manager/Director and Principal/Sub Investigators, conducts clinical research activities in compliance with study protocols, company procedures, and regulatory guidelines (FDA, GCP, ICH). This role ensures the execution of assigned studies while adhering to GCP, ICH, HIPAA, FDA Regulations, and SOPs.

Requirements

A Medical Assistant diploma, LPN/LVN, EMT credential AND 2+ years of clinical research coordination experience, OR an equivalent combination of education and experience
Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm)
Performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc
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

Nice To Haves

Proficiency with performing basic clinical procedures such as (blood pressure, vitals, EKGs, phlebotomy, etc.) is highly preferred
CCRC or CCRP credential
BLS certification
Bi-lingual (English / Spanish) proficiency

Responsibilities

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
Performing 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
Completing all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.
Preparing and attending site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed
Handling all IRB functions for assigned studies independently, and/or with assigned regulatory team member, as needed
Assisting with training of new research assistants and coordinators
Assisting with scheduling and planning for visit capacity for assigned studies
Setting up, training and maintaining all technology needed for studies
Assisting with study recruitment, patient enrollment, and tracking as needed
Handling more complex study assignments and volumes
Participating in community outreach / education events
Maintaining confidentiality of patients, customers and company information
Performing all other duties as requested or assigned