Clinical Trial Associate II - [A152]

Ubicación:
Madrid, Madrid provincia

Descripción completa del empleo:

POSITION TITLE: Clinical Trial Associate II
DEPARTMENT: Ora Europe
LOCATION: Remote, Spain

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.

The Role:
Ora's Clinical Trial Associate II (CTA II) assists Project Managers in clinical study conduct for clinical ophthalmic projects in posterior, anterior, and med device. They support the oversight feasibility including but not limited to, working with sites to generate contracts and budgets, collecting regulatory documents, and scheduling follow up patient visits of all clinical sites and ensures compliance with (GCP) protocol along with overall clinical objectives. Ora's CTA II's participate in all phases of clinical studies including start up, study maintenance, and close-out activities in addition to performing additional day to day activities under the guidance of the Sr. CTA/Lead, Assistant Project Managers and Project Managers and liaise between field and office and are expected to work more autonomously and independently than the CTA I.

What You'll Do:
- Ensure study documentation, communication, training and data collection is aligned with study protocol adherence, and all applicable SOPs, regulations and guidelines.
- Lead the development of assigned study-related documents (e.g., informed consent, source documents, study logs, etc.).
- Participate in all phases of clinical trial site management from study start-up, through study conduct and completing closeout activities.
- Collect and review site regulatory documents for accuracy and completion (1572, Financial Disclosure documents, CLIA waivers, etc.).
- Prepare essential documents package to support investigational product release for study and site approval as well as applicable study and site continuity report submissions and close-out submissions.
- Create regulatory packages for IRB/IEC study and site submission, as well as applicable continuity report, and close-out submissions.
- May assemble and distribute regulatory binders to clinical sites and provide monitors with Investigator Site File tracker in support of monitoring visits.
- Support project management activities including providing meeting minutes/agendas and weekly newsletter to the clinical team, as well as maintaining the clinical study tracking systems.
- Assist project managers in preparing study reports and collecting site status updates and study metrics.
- Set-up and maintain the Trial Master File/electronic Trial Master File, and applicable filesharing platforms (i.e. Box.com, department server files) for clinical projects.
- QC Trial Master File (for clinical projects where individual is not setting up and maintaining the file).
- Participate in Study Operations planning, Risk Assessment discussions, and Pre-Study Meetings.
- Provide support to Clinical Operations for implementing process improvement actions, performing bi-annual reviews of applicable SOPs, and conducting departmental training sessions.
- Assist with Sponsor/IRB/IEC audit preparations and participate in response to audit findings.
- Travel Requirements less than 10%.
- 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 and a minimum of 1-year experience in clinical trials associate. Years of experience may be considered in lieu of degree.

Additional Skills & Attributes:
- Ophthalmic experience is strongly preferred.
- Ability to work both alone as well as in a semi-virtual, cross-functional team environment.
- Ability to apply analytical and problem-solving skills; ability to act with a consistent sense of urgency and acute attention to detail.
- Knowledge of GCP/ICH regulations.
- Experience maintaining electronic trial master files.
- Excellent verbal and written communication skills.
- Exceptional organizational and time management skills in order to manage multiple trials, critical tasks and departmental process improvement efforts.
- Ability to remotely problem-solve with members of site staff.

Competencies and Personal Traits:
- 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. 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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