Senior Clinical Research Associate - Redwood City

Lieu: United States - Redwood City

Fonction: Research and Development

Compagnie: Relypsa

Niveau de Séniorité: Specialist

Votre profil

Responsibilities:

Reporting to the Director, Clinical Operations, the Senior Clinical Research Associate (Senior CRA) supports the management of clinical trials sponsored by the company, including management of contract service providers (CROs and vendors). 


Tasks: 

Trial Management

-       Participate in development of project-specific documents (protocol, ICF), plans (e.g., Clinical Monitoring, Communication, Project Management, etc.), and other study-related documents (manuals, instructions, etc.)

-       Assist in development of Case Report Forms (CRFs)

-       Manage creation of study-related templates and logs by CRO

-       Manage investigative site selection process for clinical trials

-    Manage external vendors that provide systems supporting clinical trial conduct (e.g., CTMS, EDC, IWRS, eTMF, etc.)

-       Coordinate and participate in Investigators’ Meetings

-       Train CRO CRAs on internal company processes

-       Conduct site visits (e.g., site selection visits, pre-study site visits, training visits, site initiation visits, interim monitoring visits, and close-out visits)

-       Review and follow-up on monitoring visit reports ensuring adherence to GCP/ICH

-       Manage investigational product accountability and reconciliation process

-       Prepare internal and external memos, reports, documents, and correspondence required to properly manage and document activities on clinical studies

-       Assist in query resolution and data listings review process prior to the database lock

-       Coordinate the collection and management of clinical trial documentation to be filed in Trial Master File and Electronic Study Files

Collaborate internally

-       Participate in project team meetings and collaborate with other functional groups within the company (Clinical Development, Drug Safety and Pharmacovigilance, Biometrics, Clinical Research Compliance, Regulatory, QA, Pharmaceutical Operations, Legal, Medical Affairs, etc.) to achieve clinical study goals and timelines

Assist in preparation and QC of Clinical Study Reports 

Qualifications:

The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience, and knowledge, or the equivalent:

Minimum Requirements

-       Bachelor’s or higher degree in science, nursing, or equivalent with 4+ years of experience in biotech, pharmaceutical, or CRO industry

-       Strong working knowledge of FDA and EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials 

-       Experience in site monitoring and oversight of contract service providers

-       Familiarity with pharmaceutical and medical terminology

-       Proficiency in Microsoft Word, Excel, PowerPoint, and Publisher

-       Experience with different EDC and IWRS platforms

-       Travel required (~10%)

Preferred Requirements

-       Experience in international clinical trial operations



A propos de nous

Le groupe Vifor Pharma est une entreprise pharmaceutique internationale spécialisée. Son ambition est de devenir le leader mondial dans les domaines de la carence en fer, de la néphrologie et des traitements cardio-rénaux. L’entreprise est le partenaire de choix pour les médicaments et les solutions innovantes axées sur le patient. Le groupe Vifor Pharma aspire à aider les patients du monde entier atteints de maladies graves et chroniques à mener une vie meilleure et plus saine. La société développe, fabrique et commercialise des produits pharmaceutiques offrant des soins de précision aux patients. Le groupe Vifor Pharma occupe une position de premier plan dans toutes ses activités clés. Il se compose des entreprises suivantes: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (sa société commune avec Fresenius Medical Care); et OM Pharma.

Le groupe Vifor Pharma a son siège en Suisse et est coté à la Bourse suisse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

Pour de plus amples informations, veuillez consulter http://www.viforpharma.com/fr/a-propos-de-vifor-pharma/qui-sommes-nous.

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