Senior Clinical Research Associate
About the Company:
Surface Ophthalmics is a pharmaceutical company focused on development and commercialization of innovative therapeutics for ocular diseases. Our current drug pipeline, all of which use a patented delivery vehicle, consists of three proprietary drug candidates for the treatment of: i) mild to moderate dry eye disease (DED), ii) acute DED, and iii) pain and inflammation for patients recovering from ocular surgical procedures. Together our product candidates address a multibillion-dollar market in the U.S and around the world. We are a start-up company with a small, closely-knit team. As we grow our programs and operational complexity, we are adding key positions to support our business.
Surface is headquartered in Pleasanton, California and offers a hybrid office & home work environment for most positions. The people at Surface are a dedicated, fun, and caring group to work with. We value initiative, collaboration, transparency, integrity and a drive for achieving our common objectives.
About the Opportunity:
A Clinical Operations Senior Clinical Research Associate (Sr. CRA) focuses on Clinical Operations study execution responsibilities and may also take on a small amount of selected additional functional management and/or departmental infrastructure responsibilities.
A Sr. CRA will primarily be responsible for managing assigned day-to-day Clinical Operations activities associated with the execution of the clinical trial. It will be the Sr. CRA’s responsibility to escalate Clinical Operations study issues and risks to the study team.
Depending on experience, level of competency and available capacity, a Sr. CRA may take on the role of the Clinical Operations lead for day-to-day Clinical Operations functional activities associated with the execution of assigned clinical trial(s).
May include all or part of the following:
- Manage Clinical Operations study activities – start-up, maintenance, close-out – including:
- Timeline execution; budget management; issue identification, resolution and escalation
- Meeting minutes review, action item tracking to resolution
- Initial essential regulatory documents package review and approval
- Feasibility questionnaire evaluation and site selection review and assessment (targeted)
- Informed Consent From (ICF) template development, ICF review and oversight
- Study plan/study manual/study document development and maintenance (targeted)
- Site engagement visits and/or clinical site observational visits
- Trip report review, trend collation, issue resolution (targeted)
- eTMF related tasks (targeted)
- Clinical Operations data review activities
- Conduct protocol deviation review/collation/escalation
- Supporting Investigational Product (IP) package approval
- Clinical supply demand planning
- Participation in risk assessment/risk management process
- Support the identification of Clinical Operations’ best practice needs and lessons learned
- Manage one or more study vendors (Contract Research Organizations [CROs], Interactive Response Technology [IRT] and specialty vendors), including:
- Communication; project management and budget management
- Issue identification, resolution and escalation
- Support Clinical Operations team by taking on specific other functional assignments, as needed.
- Bachelor of Science or Bachelor of Arts degree in a relevant scientific discipline (or equivalent) and 4+ years of relevant clinical research experience the pharmaceutical, biotechnology, and/or CRO industries (i.e., working on clinical trials at a biotech, pharmaceutical or CRO company)
- Solid working knowledge of and experience in clinical drug development in the pharmaceutical, biotechnology, and/or CRO industries, including clinical research study planning and execution; project and site management; site monitoring/monitoring oversight; vendor/CRO management, as well as budget negotiations and management
- Excellent working knowledge of GCP and regulatory requirements (e.g., FDA regulations and other requirements applicable to clinical research studies)
- Excellent computer skills (Microsoft Office Suite, IRT/EDC/eTMF applications)
- Flexible team player who consistently demonstrates the following competencies:
Collaborate: Participate and actively contribute to a joint effort of multiple individuals to accomplish a task or project. Understand and pursue mutually beneficial working relationships to move projects toward objectives. Build relationships with others and show consideration; treat others sensitively, fairly, and consistently.
Communicate: Understand the views of others and communicate in a realistic and practical manner using appropriate language. Listen attentively to views and issues of others. Share information in a timely manner that impacts others. Select appropriate methods of communication for each situation and communicate with respect, clarity, transparency, and honesty.
Deliver on commitments: Deliver on deadline and scope commitments with high quality outcomes. Be trustworthy in team situations and set appropriate expectations for work planning. Hold self and others accountable for delivering on goals and commitments. Actively seek clarity if expectations are not clear. Operate transparently and share accountability through active collaboration with others across functions.
Proactively plan and organize: Organize time effectively, create work schedules, prioritize, prepare in advance, and set realistic timescales. Visualize a sequence of actions needed to achieve a specific goal and how to estimate the resources required. Anticipate and adjust to change. Look for patterns and trends from diverse perspectives. Proactively adjust behaviors, plans to accommodate changes.
Solve problems: Analyze situations, diagnose problems, identify the key issues, establish and evaluate alternative courses of action and produce a logical, practical and acceptable solution. Take an overview and identify patterns, trends and long-term possibilities. Understand, link and analyze information to understand issues, identify options and support sound decision making. Seek ways to provide added value. Demonstrate recognition and development of new ideas and opportunities. Think critically about how to do things better and encourage new approaches and ideas.
Adapt: Welcome alternative thought processes, methods and approaches to problem.
Keep composure: Exercise self-control under trying or tough circumstances or situations or under any kind of pressure. Deal with interpersonally and/or politically challenging situations calmly and diplomatically, diffuse tension. Remain focused, try to think clearly and take appropriate decisions even under ambiguous, doubtful, stressful, dilemma and crisis situations. Thoughtfully intervene in conflicts to facilitate communication and resolve problems, find common ground when possible. Motivate others to concentrate on finding solutions to problems rather than getting overwhelmed by stresses and strains involved. Exude calming effect on the people around.
What’s in it for you:
Our employees enjoy benefits that make them more productive and contribute directly to the development of their professional skills. We want to be able to attract the best of the best and make sure they keep getting better. On top of an exciting and intellectually challenging workplace, we are offering:
- Work in a highly dynamic industry with a company focused on innovative science
- A hybrid home/office work schedule
- Collegial and supportive colleagues in a fun environment where personal development and success are high priorities
- Competitive medical / dental / vision packages
- 401K with company match
Surface is an equal opportunity employer. We want applicants of diverse backgrounds and hire without regard to race, color, gender, religion, national origin, ancestry, disability, age, sexual orientation, or any other characteristic protected by law.
Please send your resume and brief cover letter to: firstname.lastname@example.org.