Our mission at Progenity is simple: to help healthcare providers and patients prepare for life. We provide the most advanced molecular technology and the highest levels of service to guide patient care at critical life stages. We continually seek people with the motivation and skills to advance our mission.
The Clinical Trials Associate is responsible for providing support to Clinical Affairs for departmental and project-related requirements.
RESPONSIBILITIES
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Interacts with personnel from investigative sites, vendors, and Progenity functional groups to enable timely and high-quality initiations and completions of clinical trials.
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Compiles documentation for qualification of clinical sites and supports review of that documentation to ensure that those clinical sites comply with ICH-GCP and relevant local regulations.
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Assists with preparation and submission of regulatory documents to responsible authorities and IRB/ECs.
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Establishes, maintains, and archives files of essential documents from investigative sites and for inclusion in Trial Master Files. These files must be maintained in a fashion so that they are continuously available for audit and completion for archive.
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Contributes to the development of documents that facilitate or describe the management of the clinical trial. Examples of such documents include Protocols, Informed Consent Forms, Monitoring Plans, study guides or manuals, and information collection tools.
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Assists with the preparation of contracts with vendors and investigation sites.
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Ships and tracks trial documents (site binders, manuals, guides, etc.).
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Records and receives inventory visit reports from monitoring staff.
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Supports site management.
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Communicates directly with sites to provide direction, to assess performance, and to propose interventions to enhance enrollment performance.
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Maintains study portals, web sites, or newsletters.
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Compiles reports progress/status of investigation sites.
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Assists with processing vendor invoices, investigator payments, and expense reports.
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Participates in the development and maintenance of and adhere to departmental SOPs and guidelines.
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Prepares, maintains, and completes training on study-specific and/or applicable SOPs.
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Supports sites in their efforts to prepare for audits conducted whether by sponsors or regulatory authorities.
This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as deemed necessary.
REQUIREMENTS
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Bachelor’s degree in Life Sciences or health-related field highly preferred.
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2+ years of experience in administrative support required preferably within a pharmaceutical, biotechnology or CRO setting.
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Excellent command of verbal and written English.
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Expert use of the MS Office suite is essential.