Site Development Associate (Anterior Focused) - Ora
Andover, MA
About the Job
POSITION TITLE: Site Development Associate
DEPARTMENT: OraNet
Ora Values the Daily Practice of …
Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor
At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.
The Role:
The Site Development Associate is primarily responsible for supporting OraNet's Anterior Segment group, with occasional Posterior Segment involvement. This primary aim for this position is to support the successful growth and maintenance of Ora's (Anterior) Alliance Site Network, and to assist in relationship management.
The Site Development Associate is accountable for identifying clinical sites to potentially add to the Alliance Network, managing site intelligence, gathering & reporting on Alliance site KPIs, tracking site support needs & initiatives, and assisting with site communications. This role will also actively contribute to site relationship engagement, conduct monthly check-in calls, and facilitate resource sharing among OraNet sites. Additionally, they play a pivotal role in drafting and executing CDAs, maintaining filing systems for site contracts, and collaborating with integrated departments for consistent growth.
What You'll Do:
- Assist in the execution of the integrated research activities of Ora's Alliance Site Network.
- Assist with identifying and evaluating new clinical sites to support the delivery of Ora's portfolio of programs and therapeutic areas.
- Support the onboarding of new clinical sites into the Alliance network.
- Contribute to the facilitation and communication of site-related training curricula.
- Assist with capturing and updating new site lead information, while managing communication patterns in OraNet's site lead database.
- Scheduling calls with sites and serving as initial OraNet point of contact to site staff.
- Assist with the ongoing capture and reporting of key performance indicator metrics at OraNet partner sites through database exports and Excel trackers.
- Assist as a liaison between network sites and study teams to ensure timely start-up, enrollment, and quality.
- Triage site questions and work with OraNet managers in build-out and roll-out of site trainings.
- Drafting, filing and facilitating execution of CDAs and OraNet agreements.
- Maintaining a filing system in SharePoint and Monday for site contracts and documents.
- Tracking of OraNet Site feasibility questionnaires and issues.
- Track compliance with GCP and SOP guidelines for sites within the network.
- Manage and upkeep site documentation on Monday.com and SharePoint for both segments.
- Attend study team meetings for OraNet CAPA support.
- Be fluent in Ora's various operational models (such as Block Enrollment) to support site engagement and ensure sites are aligned and can deliver to the various models employed at Ora.
- Assist and collaborate with integrated departments (recruiting, marketing, business development) to ensure consistency and communication to further grow OraNet.
- Conduct monthly site check-in calls, managing conference attendance, and facilitating resource sharing/strategies among OraNet sites.
- Developing resources (e.g., SOP flowcharts, R&R Chart, OraNet FAQs) for partner sites.
- Adhere to all aspects of Ora's quality system.
- Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements.
- Clear and sustained demonstration of Ora's values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.
- Responsibilities may differ from the above based on the specific needs of the business.
What We Look For:
- Experience Needed for the Role:
- Bachelor's degree in applied or life science, a minimum of 2 years' experience in clinical trials, or equivalent training and work experience.
- Additional Skills & Attributes:
- Knowledge of pharmaceutical business, worldwide drug development, and regulatory process.
- Independent thinking, creativity, and innovation.
- Excellent communication and presentation skills with emphasis on building consensus.
- Strong interpersonal skills.
- Excellent written and verbal communication skills.
- Advanced command of site-facing relationship strategies.
- Training experience.
- Competencies and Personal Traits:
- What We Do:
- Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
- How We Do It:
- IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
- Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.
- Why We Do It:
- Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see.
- What We Do:
What We Offer:
- Well Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
- Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays.
- Financial: Competitive salaries along with a 401K plan through Fidelity with company match.
- Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave.
- Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure.
- Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases.
- Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family.
- Career Development Opportunities: Continued opportunities to grow and develop your career journey.
- Global Team: Opportunities to work with colleagues across the globe.
- Impact: A chance to research new ophthalmic therapies that will impact patients across the globe.
Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.
Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member.
We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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