Senior Clinical Research Associate - Redwood City

Location: United States - Redwood City

Division: Research and Development

Company: Relypsa

Seniority Level: Specialist

About You

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 CRO and vendor selection process

- Provide project-specific support for external study team (personnel at CRO and other clinical study vendors), ensure proper adherence to clinical research regulations

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

- Track status of clinical trial deliverables

- Support site recruitment, and patient recruitment

- Coordinate and participate in Investigators’ Meetings

- Train CRO CRAs on internal company processes

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

- Manage investigational product accountability and reconciliation process

- Contribute 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

- Oversee and 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 54+ 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

- Previous experience in a lead CRA role in a Sponsor or CRO setting

- Previous experience in clinical trial management activities (e.g. clinical trial setup, execution)  

About Us

Relypsa, Inc., a Vifor Pharma Group company, is a biopharmaceutical company focused on the development and commercialization of late-stage medicines in the iron deficiency, nephrology and cardio-renal therapeutic areas. Relypsa is committed to delivering innovative therapies and improving the lives of patients with serious and life-threatening conditions that are often overlooked and undertreated. The Companys first medicine, Veltassa® (patiromer) for oral suspension, was approved by the U.S. FDA in October 2015, making it the first approved medicine for the treatment of hyperkalemia in more than 50 years. More information is available at www.relypsa.com or check out our LinkedIn page.

Show/hide content

Apply
Share
Xing Send to a friend

Agency Policy