About Us

Spero Therapeutics (Nasdaq: SPRO) is a multi-asset pre-commercial stage biopharmaceutical company in Cambridge, Mass. We are highly committed to advancing novel treatment approaches for bacterial infections with a world-class team of biotech and drug development experts. The company has a pipeline of novel and highly differentiated antibacterial and rare disease product candidates focused on patients with unmet need associated with multi-drug resistant (MDR) bacterial infections. Spero’s lead product candidate, SPR720, is an oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease, a rare orphan disease. Spero’s partnership directed programs consist of SPR206 and tebipenem HBr. SPR206, is an IV-administered agent being developed as an innovative option to treat MDR Gram-negative bacterial infections and tebipenem HBr, is an oral carbapenem being developed as the first oral carbapenem antibiotic for use in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). In September 2022, Spero announced an exclusive license agreement with GSK for worldwide rights of tebipenem HBr, except for Japan and certain Asian countries. We believe that our novel product candidates will have a meaningful impact on patient health and significant commercial applications for treating MDR infections in hospitals and community settings.

Overview

The Senior Clinical Research Associate (CRA) collaborates with cross-functional team members to assist the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administrative and project tracking.

What you'll do

• Assist with the planning and implementation of anti-infective clinical research studies on schedule and within budget.
• Work alongside Clinical Project Managers to perform study management and vendor oversight activities.
• Review study documents including but not limited to: site essential regulatory documents, informed consent forms, monitoring reports, site visits metrics, communication with monitors and sites, study plans and manuals.
• Review TMF plans, and Perform TMF quality control reviews .
• Organize and prepare study files for submission to the TMF within established guidelines.
• Participate in the training of CRO teams, investigators and staff as needed.
• Attend both internal and external meetings, assist with generation and maintenance of meeting materials, capture meeting minutes and track action items as required.
• Assist project teams with study specific documentation and guidelines as appropriate.
• Establish and maintain study tracking tools.
• Manage incoming correspondence, internal documentation, etc., as appropriate.
• Be familiar with ICH GCP, appropriate regulations, relevant SOPs and internal tracking systems.
• Assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals and provide general administrative support to the Clinical Operations Department.
• Assist with the development of standard operating procedures (SOPs), work instructions (WIs).
• Collaborate with cross-functional study execution team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and Spero SOPs.
• Other duties as assigned.

What you'll need

• Bachelor’s degree, preferably in life science
• 3 years’ experience in a CRO, pharmaceutical, or biotechnology company.
• Tech savvy with high proficiency in Microsoft Excel, as well as Project, Word, and PowerPoint.
• Logical thinker, who is highly adaptable, proactive, deadline- and detail-oriented.
• Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.
• Willing to embrace new challenges and to take on increasing levels of responsibility.
• Thrives in a fast-paced environment, working both independently under general direction and as part of a team, and able to shift priorities as needed.
• Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.
• Willingness to travel for job related activities if required (expected travel for this position is <10%).

By joining our committed and highly motivated team, you’ll experience a workplace culture that is inclusive, fair, challenging, supportive, and respectful. Spero’s culture is one that emphasizes “servant leadership,” or putting ego aside and working for the benefit of the team and our patients, and values our colleagues’ opinions and celebrates accomplishments in service of patients. Spero provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Spero requires all employees to be vaccinated against COVID-19 absent a bona fide medical reason or genuine religious belief relating to vaccinations. All employees must be in compliance with Spero Therapeutics’ COVID-19 vaccine policy at the time of employment.