The CRA is an important member of the Alira Health Clinical team. The CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The CRA works closely with Lead CRAs, Sr CRAs, in-house CRAs, Associate Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.
Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed.
Ensures appropriate and timely investigator site visits.
Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues.
Assists in development of study-specific Monitoring Plans and training presentations as required.
Assists in set up/collection of site specific ethics documents and site contract negotiation as required.
Provides monthly billing information to finance team as required.
For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor.
Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits.
Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
Ensures integrity of CRF data through meticulous and thorough source document review and verification.
Performs quality control and verification of documents collected at sites for eTMF/TMF.
Conducts investigational product accountability.
Reviews site regulatory binder for required documents.
Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.
Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs.
Participates in internal, client/sponsor, scientific, and other meetings as required.
Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs.
Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data.
Proactively identifies site issues and develops problem-solving strategies for sites.
Conducts audit preparation at study sites as needed.
Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.
Participates in internal, client/sponsor, scientific, and other meetings as required.
Assists in CRA new hire training and onboarding.
Performs CRA mentoring.
Collaborates with development and maintenance of Clinical Trial Management System (CTMS).
Manages and resolves conflicting priorities to deliver on commitments.
Performs additional duties as assigned.
EU: Graduation in a scientific health field.
EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011.
Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members.
Ability to autonomously manage monitoring activities.
Quality focused; Proven ability to be careful, thorough, and detail-oriented.
Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment.
Able to manage priorities, organize time and solve problems.
Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills.
Ability to travel.
Ability to manage stress.
Professional, trustworthy and disciplined.
Ability to problem-solve unstructured or ambiguous challenges.
Strong command of Local language, both written and verbal, in the country where monitoring activities are performed.
Excellent communication and interpersonal skills with customer service orientation.
Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture.
Self-starter who thrives in a collaborative, yet less structured team environment.
Knowledge of clinical research, ICH GCP and local regulations.
Knowledge of Regulatory and Ethical requirements.
EU: Adequate English.
Languages English
Education Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences
Contract Type Regular
Alira Health...Job Description Job Description We are seeking a Fast Food Restaurant Managerto join our team! Youwill be responsible for providing customers with a memorable dining experience. Responsibilities: Supervise andcoordinate all culinary activities Oversee...
...people. We deliver a blockchain intelligence data platform to financial institutions, crypto companies, and governments to fight cryptocurrency fraud and financial crime. We consider our business and our profit as a way to move towards our mission sustainably and at...
...Director, Media Sales - Beauty - Macy's Media Network At Macy's, Inc. we're on a mission to create a brighter future with bold representation for all. This is our Mission Every One. We know that each person here is unique. So we respect and invest in each individual...
...Job Description Job Description General Description: Responsible for safely and efficiently operating a vacuum truck and dump truck as needed. Key Duties: ~ A valid CDL class A or B with good driving record is required ~ Ability to operate equipment safely...
...are running profitable restaurants. As a District Manager/Area Coach you would be expected to: * Lead the daily operations of 6-8... ...Drive top-line Sales & Traffic growth in your Area * Deliver Financial Results by controlling COS, COL, and Semi-Variable Costs * Ensure...