Clinical Research Manager/Associate - Seattle, WA | Biospace
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Clinical Research Manager/Associate

Sound Pharmaceuticals

Location:
Seattle, WA
Posted Date:
9/11/2017
Position Type:
Full time
Job Code:
Salary:
100K / Experience
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Position Summary
The role of the Clinical Research Manager/Associate is to develop operational aspects of clinical trial protocols, including case report forms and manage all aspects of clinical trial performance. This role requires close collaboration with internal teams, vendors, investigators, site coordinators, hospital staff, statisticians and external consultants.

Sound Pharmaceuticals, Inc. is a clinical stage biotechnology firm located in Seattle Washington.  SPI is a pioneer in neurotologic drug development aimed at treating sensorineural diseases of the inner ear.  Our expertise in molecular biology, immunohistochemistry and electrophysiology have led to the development of preclinical models of hearing loss and tinnitus that are translating into novel and successful clinical trials.
We are seeking team members having substantial clinical trial experience with a growth pathway of site management to in-house sponsor management.  We value team members that will contribute in addressing a novel and underserved therapeutic space in hearing loss and additional neurological conditions.  You will be an early team member to the organization; comfort in learning and contributing to non-core functions is essential.  

Requirements

Primary Responsibilities
•   Perform onsite data monitoring visits as required by the protocols,
•   Prepare documentation as required for clinical trials ensuring all aspects for good clinical practice (GCP) are compliant,
•   Collaborate with data management throughout lifecycle of study,
•   Develop clinical trial protocol related operational documents, such as case report forms, data management plans, and data clarifications,
•   Ensure accurate and timely data collection, entry, and query resolution,
•   Contribute to Standard Operation Procedure development,
•   Guide management of timelines, resource use, planning and reporting for assigned functions on a clinical trial,
•   Contribute to process quality control activities (e.g. quality checks and balances to ensure inspection readiness, Enrollment, Metrics, Milestones, Timelines and Budget)
•   Aid in reconciliation of site and/or vendor invoices

Qualifications
•   Consistent history of learning and teaching in the clinical research arena,
•   Ability to identify issues, analyze situations and provide effective solutions,
•   Skilled with interpersonal relationships, team building, motivating, mentoring associates
•   Bachelor’s Degree in science related field or equivalent experience,
•   Expert knowledge of Federal, EU and ICH framework for conduct of clinical trials,
•   Adherence  to Standard Operating Procedures (SOPs),
•   Experience in management, tracking status and co-ordination of multi-center clinical trials,
•   Resilient organization and planning skills with an attention to detail and accuracy,
•   History of building site and vendor relationships: excellent interpersonal interactions with clinical site personnel,
•   Proficient with conventional software and systems: e.g., Microsoft Office Suite, EDC, and CTMS,
•   Savvy with clinical information technology, paperless clinical trial documentation
•   Experience navigating drug development

Additional Desired Qualifications (Experience or Interest)
•   Experience with or interest in learning submission of PIND, IND, CTA, NDA and others as needed in electronic formats,  
•   Regulatory document submission tracking and forecasting – ensuring submissions are compliant and submitted on schedule,
•   Experience with or interest in maintaining current knowledge of internal and external document formatting and regulatory publishing requirements and industry best practices,
•   Review of Regulatory documents, to include working with cross functional contributors regarding discrepancies, deficiencies and errors,
•   Experience with or interest in compiling and publishing of routine submission of INDs (new applications, safety reports, investigator information, protocol amendments, etc.), NDAs (original submissions, supplements, responses), etc., on a routine basis

Work Environment
•   Travel: Position requires travel up to 10 to 50% dependent on routine waxing and waning of clinical research,
•   Position is based in Seattle Washington,
•   Physical Demand: Light physical effort,
•   Mental Demand: Moderate to high degree of concentration due to volume, and complexity, comfortable with lean infrastructure and working in a virtual pharmaceutical company environment

Benefits
Full healthcare benefits include: Medical, Dental, Vision, potential annual bonus based on performance  and participation in employee stock incentive program