(Regional with Device experience)
Seeking Regional Monitors for great opportunity with fabulous client!
The Role and your Responsibilities
The Sr. Clinical Research Associate is responsible for establishing, managing and meeting the milestones of a clinical study in compliance with applicable clinical and regulatory standards and in alignment with business needs. This role works independently and under only general direction. Major deliverables are reviewed to ensure clinical and business requirements are met. This position may also serve as a trial manager depending on the complexity of the trial and may provide work direction to other team members supporting the trial. The role ensures that clinical study management including the design, initiation, management, monitoring and closing of the study are appropriately executed for either their assigned sites.
- Follow all work/quality procedures to ensure quality system compliance and high quality work.
- Drives process to determine study objectives, strategy, scope, and schedule in order to meet business needs
- Develops the required clinical documents (e.g., Investigator Brochure, Clinical Management Plan, Clinical Investigational Plan) in consultation with the cross-functional team, investigators, and the core clinical team.
- Establishes selection criteria for principal investigators and investigative sites and drives center selection process.
- Responsible for site identification, qualification, initiation, training, monitoring, and close out activities to ensure study compliance and subject protection.
- Assures training of investigators, center staff and clinical staff.
- Responsible for site monitoring (review source documentation, case report forms, and data reports for accuracy and ensure the timely submission of such documentation) to assure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB, and sponsor standards, guidelines and policies.
- Prepare accurate and timely monitoring reports to study management and follow action items through resolution.
- Ensure accurate inventory accountability of investigative product at clinical sites
- Supports interactions with regulatory agencies including meetings with the Food and Drug Administration (FDA) and FDA panel meetings regarding requirements and results of the study.
- Ensures site activities in line with milestones (i.e. startup, recruitment, closeout, etc) and implement contingency plans as needed
- Responsible for accurate and timely adverse event reporting during the study.
- Will ensure site adherence to FDA, Regulatory, IRB and sponsor requirements.
- Work with investigators to quickly and effectively resolve problems.
- Evaluates clinical data/information and prepares interim and final reports.
What is Required
- BS or BA with a minimum of 4+ years of Monitoring
- 2+ years of device experience (recently - within the past 3-5 years)
- Clinical research includes:
- Industry sponsored clinical research, physician sponsored clinical research, and government sponsored clinical research, or any other clinical research that would lead toward regulatory submission, review, and approval for market clearance.
- Similar medical/scientific experience (e.g., has written and implemented protocols for experiments or animal research, has a good understanding of the research process) may be acceptable.
What is Offered
DOCS clients include small, mid and large sized Pharmaceutical companies in addition to many leading Biotechnology, Medical Device companies and CROs. As a global partner, DOCS currently offers global resourcing solutions to our clients.
We offer competitive pay, comprehensive benefits including paid days off, 401K, and health insurance.
DOCS/ ICON Clinical Research is an Equal Opportunity Employer committed to strength in diversity.