Clinical Research Associate CRA

Electrophysiology Research Foundation
Warren County, NJ
Closing date
Sep 26, 2021

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Pharmaceutical, Clinical Research Associate
Job Description



The Clinical Trial Research Associate (CRA) contributes to the operational execution of multicenter and local clinical studies for the Electrophysiology Research Foundation to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs. Responsibilities may include performance and quality oversight of one or more subcontract research organization (SCRO) teams and clinical study sites. The CRA is responsible for clinical monitoring of assigned projects and sites in accordance with SOPs, Good Clinical Practice, ICH Guidelines, local regulations and additional sponsor requirements. All activities are performed in the interest of subject safety and vigilance against fraud.

Project Management
- Provide operational input on development, management and maintenance of study deliverables [i.e. timelines, study plans, documents, etc.] through collaboration with internal and external team members for the execution of the clinical trials.
- Lead / Participate in monitoring visits to clinical sites and report/review process in order to achieve effective clinical monitoring, data quality and adherence to protocol and established processes and plans
- Support sponsor/ regulatory or health authority inspections and CQA audits as required
- Ensure full compliance (completeness & accuracy) of the required data in study management tools including monthly or quarterly reports, patient enrollment forecasting, etc.
- Proactive identification of potential risks and development/implementation of actions to avoid or mitigate trial issues
- Develop and maintain collaborative relationships with internal and external partners/stakeholders

Study Planning and Conduct
- Collaborate with sponsor/subcontractors and other internal stakeholders regarding study specific issues and follow through to resolution
- Manage drug supply inventory, set-up, ongoing quality review, and final reconciliation
- Actively contribute to study meetings including presentation subject matter expert, generate, finalize and distribute study team agendas and meeting minutes / coordination of study training for investigational sites and staff
- Contribute to oversight of the required regulatory IRB/IEC approvals/notifications for the Foundation and clinical sites
- Assist with the collection of various study documents such as insurance, study approvals, amendments etc.

Study Administrative Support

- Contribute to ordering and distribution of materials as required
- Manage study-level drug shipment to sites
- Support the development/coordination of study materials for study team, investigational sites in conjunction with study leadership
- Manage collection, review and tracking of study documents as necessary
- Assist with Investigator meeting coordination and planning
- Assist with compilation of Clinical Study Report appendices

Financial Planning and Management Experience
- Manage subcontractor and site payment processing and tracking
- Assist with maintenance of study budget tracking tools and reconcile invoices with overall contract/budget and finance reports

Skills/Knowledge Required:
- Strong oral and written skills with proficiency in English
- Knowledge of ICH/GCP and regulatory guidelines/directives
- Demonstrates analytical approach and anticipation of problems
- Identifies gaps and provides constructive feedback and solutions
- Ability to multi-task effectively and prioritize assignments from multiple sources
- Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments
- Basic understanding of project management desired
- Excellent organizational skills
- Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint
- Knowledge of study tools including electronic system skills such as CTMS / EDC
- Knowledge of drug development process

Key Competencies

- Proactively shares information, ideas, input, and/or expertise with team members
- Demonstrates concern for high quality outcomes
- Displays a willingness to challenge the status quo and take risks
- Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute
- Accepts challenging assignments and new responsibilities
- Develops and maintains effective working relationships and demonstrates cross-cultural sensitivity when working with others
- Uses different communication methods appropriately (e.g., email, voice mail, face-to-face)
- Keeps study chair and study leadership informed of progress and seeks guidance when deadlines or goals are in jeopardy
- Promptly communicates information that others need to know in order to do their jobs

- Basic knowledge of research processes and cardiovascular study experience required
- Thorough knowledge of ICH / GCP
- Good oral and written communications skills
- Intermediate computer skills
- Knowledge of budget and invoicing requirements
- Degree in life science or nursing qualification preferred or other equivalent experience or education; - Field based monitoring experience in Clinical Research, including site management; - Must have current driving license. Travel time is study dependent. - Experience in pharma/CRO/healthcare; - Authorized to work in the US for any employer

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