Type: 12 Months contract
Location: Fully Remote, East Coast, US
The Clinical Research Associate is working closely with the Clinical Project Manager (CPM) and is responsible for assisting in the planning and execution of clinical trials which includes assistance in vendor and site management and coordinating / leading data review. Conduct site visits (pre-study, initiation, interim and close out visits) to ensure protocol compliance, accurate and thought data collection, and regulatory compliance. They will support the CPM with oversight of the clinical study while ensuring the trial is conducted in compliance with the protocol, ICG/GCP, applicable regulatory requirements and applicable SOPs/Work instructions. Candidates must have the ability to prioritize multiple tasks based on workload, work in a fast-paced environment, have strong computer skills (Word Document, Excel and Power Point), maintain completion of required corporate training on standards, policies, work instructions due date.
- Act as primary point of contact for specific investigational sites and vendors as needed
- Create, implement, and maintain systems to track study metrics and general information relating to study execution. Provides the updates to the team on metrics
- Develop study tools and guidelines to be utilized by study sites
- Develop basic knowledge of the process used to evaluate and select potential investigators and sites
- Assist in trial-related documents including but not limited to Informed Consent Forms (ICF), source documents, patient instruction guides, lab manuals and Case Report Forms (CRFs) and etc.,
- Reviews site-specific study documents (site-specific ICF and study tools/worksheets), and verifies site payments
- Works closely with clinical project manager to track study metrics including CRO and other vendor activities
- Conduct periodic review of metrics for completion of study files in the eTMF. Escalates appropriately to the CPM and study team of updates and timelines regarding file completion.
- Participates in team meetings and prepare meeting minutes as applicable
- May conduct site visits as needed or accompany experienced clinical monitor for co-monitoring
- Collaborated with internal cross functional teams to ensure effective delivery of the assigned project milestones
- Support the clinical project manager in the planning and organization of investigator meetings and other meetings as necessary
- Provides support to the Clinical Project Manager in the management of vendor scope(s) of work, budget updates & reconciliation, as agreed upon with prospectively established milestones and timelines.
- Maintain completion of required corporate training on standard, policies and work instructions by due date.
- Develops basis knowledge of the investigator contract, budget, and payment process including legal language and document structure as it impacts assigned studies.
- Generate purchase orders, process vendor invoices, and assist in tracking spend approved in the budget.
- Coordinates and reviews regulatory documents from study sites; ensures completeness and accuracy.
- Performs other work-related duties as assigned.
- Minimum 2 years clinical research experience (e.g. pharmaceutical, biotechnology, CRO healthcare setting [including monitoring experience])
- BS/BA degree in a life science, RN or related field or combination of experience and training will be taken under consideration if no BS/BA degree.
- Ability to work on complex or multiple projects and exercise critical thinking.
- Knowledgeable in clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, as required.
- Demonstrates problem solving skills, self-motivated and adaptable to a dynamic environment.
- Experience in global trials and ophthalmology clinical practice preferred
- Experience in interactions with vendors (e.g CROs, central laboratories, and other vendors preferred)
- Ability to work in a dynamic, fast paced environment.
- Ability to deal with ambiguity.
- Travel may required up to 25%
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