Sr. Clinical Research Associate

Description

JOB TITLE: Sr. Clinical Research Associate

LOCATION: Remote in Cambridge, MA or Seattle, WA – eligible residents of the following states will be considered: IN, NH, NM, NY, NC, PA, SC, SD, or TX.

SALARY RANGE: $122,000 to $145,000. The midpoint of the range is $131,000. The ideal candidate would be hired at or around the midpoint.

ABOUT THE POSITION

The Sr. Clinical Research Associate (Sr. CRA) is responsible for conducting monitoring visits at clinical trial sites and conducting site management activities. This position works closely with the leads of the sub-functions of clinical operations (i.e., clinical document management, clinical project management, clinical supply management, site relations, etc.), data management, pharmacovigilance, other functions, and service providers involved in the day-to-day clinical trial execution activities.

KEY RESPONSIBILITIES

• Actively participate in all aspects of clinical trial operations, including independently conducting pre-study/qualification, initiation, interim, and close-out visits at assigned clinical trial sites.
• Conduct site management activities between monitoring visits for assigned clinical trial sites.
• Participate in the generation of monitoring document templates, monitoring SOPs, clinical trial plans, study logs, study forms, and other study specific documents.
• Complete monitoring visit documentation per plans and applicable SOPs.
• Reconcile the electronic trial master file with the investigator site file.
• Re-train site staff on therapeutic area, protocol requirements, proper source documentation, case report form completion, and investigational product handling requirements as needed throughout the study.
• Provide site feedback to internal team members.
• Implement action plans for sites not meeting expectations.
• Mentor junior CRAs and CTAs.
• Oversee the activities of co-monitors for assigned clinical trial sites.
• Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.
• Other tasks and responsibilities as needed.
• Supervisory Responsibilities: None
• Ability to travel approximately 65%.

ABOUT AURION BIOTECH

With offices in Seattle, Boston, and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. The Company’s first candidate is for the treatment of corneal edema secondary to endothelial dysfunction, and one of the first clinically validated cell therapies for corneal care; it was recently granted regulatory approval from Japan’s PMDA. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company is preparing for clinical trials in the U.S. We are growing rapidly and seek to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who share our values:

• Stewardship: We make the world a better place for our patients, our communities, our clinicians, and our colleagues. We act responsibly as individuals, as employees, and as a company.
• Transformation: We embrace our challenges, our successes, and our failures. We are curious, we take risks, and we collaborate.
• Grit: We break down walls and strive to achieve the impossible. We are persistent and resilient, and we deliver on our commitments.

Aurion Biotech has a lot to accomplish in the next few years and this role is key to our success. Privately held, Aurion Biotech is backed by leading investors that include Deerfield, Alcon, Petrichor, Flying L Partners, Falcon Vision / KKR, and Visionary Ventures. To learn more about Aurion Biotech, visit www.aurionbiotech.com

LIFE AT AURION BIOTECH

We want our people to wake up every morning excited and energized for work. We value employees, which is why we invest in making life at Aurion Biotech healthy, fun, and rewarding:

• Robust Benefits: We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
• Total Rewards: Everyone is a shareholder at Aurion Biotech. We offer competitive equity grants, salaries, and bonuses.
• Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.

Requirements

QUALIFICATIONS AND EDUCATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor’s degree in health profession, science and/or engineering field.
• A minimum of 10 years of experience in a medical device, biotechnology, pharmaceutical company, CRO or clinical trial site.
• A minimum of 7 years’ experience as a CRA/Monitor.
• Ophthalmology experience is required.
• Previous study coordinating or management experience preferred.

REQUIRED SKILLS AND ABILITIES

• Excellent written and oral communication skills.
• Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.
• Excellent organizational and time management skills, along with attention to detail.
• Ability to apply knowledge of GCP and applicable regulations and guidances appropriately