Sound Pharmaceuticals, Inc. (SPI) is a biopharmaceutical company based in Seattle, Washington that specializing in innovative and multidisciplinary approach to auditory drug development. SPI is also making significant contributions to clinical trials in the areas of Meniere’s disease, cystic fibrosis, moderate and severe COVID-19. We have an exciting opportunity for a Clinical Research Associate (CRA) to join our collaborative and proactive team. This position does not require relocation.
Under the direction of the VP of Clinical Operations and Regulatory Affairs Manager, the CRA contributes to the tactical implementation and conduct of clinical trial studies. The CRA ensures the quality of each clinical trial study through on-site and remote monitoring of protocol and regulatory compliance. The CRA represents SPI at the investigator site level and maintains collaborative relationships with investigator sites, vendors, and the internal clinical operation and development team.
- Leverage your expertise
- Build professional relationships
- Protect patients
- Ensure quality
- Drive productivity
- Opportunity to advance your career in clinical research
- Represent SPI in a professional manner; establish and maintain good relationships with investigators, study site personnel, and collaborators.
- Manage site quality and delivery from site identification through to close-out
- Conduct independent on-site and remote Monitoring procedures at assigned investigator sites i.e., Site Evaluation, Site Initiation, Interim Monitoring, and Site Close-out
- Generate visit / contact reports for approval in a timely manner
- Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff
- Develop patient recruitment strategies in conjunction with the investigator site to meet enrollment timelines while ensuring compliance with the approved protocol / amendment(s), standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s)
- Evaluate the quality and integrity of the reported data, site efficacy, and drug accountability
- Monitor the completeness and quality of Regulatory Documentation and perform site document verification
- Review electronic Case Report Forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies; initiates corrective action as required; and ensures training is provided within a reasonable timeframe, is current, and is documented appropriately.
- Provide support and contribute to department training and process improvement initiatives.
- Participate in investigator meetings, routine site calls, and other interim site meetings (if necessary).
- Ensures essential documents are filed in the Trial Master File (TMF) according to guidelines.
- Prepare, track, and manage required study documentation and supplies as needed.
- Co-monitor may be necessary
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS
- BA/BS degree in biological sciences, pharmacy, or other health-related discipline and/or successful completion of a recognized CRA training program.
- Minimum requirement: 2 years of experience in clinical research monitoring and/or site management, with understanding of clinical trials methodology, terminology, and knowledge of GCP, ICH and FDA regulations
- Ability to demonstrate high-level understanding of study protocol(s)
- Ability to perform all clinical monitoring activities independently
- Ability to prioritize and to manage multiple tasks as necessary including writing reports during travel time or remote locations such as hotels or airports.
- Strong interpersonal, written, and verbal communication skills within a matrixed team
- Experience working in a self-driven capacity and under minimal supervision, with a sense of urgency to achieve project timelines
- High function in the areas of time management, problem-solving skills, team collaborations
- Flexible attitude with respect to assignments / new learning
- Attention to detail, dedication to quality in all work tasks and deliverables.
- An honest and ethical work approach to promote the development of life changing treatments for patients
- Strong computer skills included but not limited to MS Outlook, Word, PowerPoints, Excel products, and Electronic Data Capture (EDC) systems.
- Self-motivated, assertive, and able to function independently and as part of a team.
- Ability to travel at least 40% including ground and air required
This role may be subject to government and/or investigator site requirement regarding vaccination against COVID-19 that are more stringent than Sound policy. Accordingly, successful incumbents may need to be either vaccinated against COVID-19 or have an approve religious or medical exemption.
SPI offers competitive salaries and an excellent benefits package. Moreover, successful incumbent will be able to grow and learn, as well as play a key role in our success. SPI is an Equal Opportunity Employer.
Interested candidates are encouraged to apply by sending a resume and a cover letter to info@SoundPharma.com for consideration. Sound Pharmaceuticals, Inc. is an equal opportunity employer and supports diversity in the workplace.