Clinical Research Associate Ii

Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI, within the realm of Greater Boston’s vast biotechnology landscape. Since our inception more than 20 years ago, we have been developing a proprietary biological drug device combination technology for treatment of a variety of retinal disorders. Our most advanced program is developing a treatment for the orphan disease Macular Telangiectasia Type 2 (MacTel). Our Encapsulated Cell Technology (ECT) platform is designed to deliver a genetically modified neuroprotective factor to slow the progression of this chronic retinal disease.

We are seeking a highly motivated Clinical Research Associate II who will be responsible for monitoring the progress of clinical studies at the site level, ensuring the protection of subjects' rights and well-being, and verifying the accuracy and completeness of reported study data. The CRA II plays a crucial role in ensuring that clinical trials are conducted in accordance with protocol, standard operating procedures (SOPs), ICH/GCP, and other regulatory requirements. This position provides essential support throughout the entire clinical trial lifecycle, from start-up to closure.

This a remote position and can be filled from anywhere in the United States.

Also, please note that this role is not eligible for agency recruiting support.

Job Requirements

• Clinical Trial Monitoring: Conduct regular on-site and remote monitoring visits to ensure protocol compliance, patient safety, and data integrity.
• Site Management: Foster strong relationships with investigative sites, providing support and guidance to ensure smooth trial conduct. Address site queries and concerns promptly.
• Regulatory Compliance: Ensure that all clinical trial activities adhere to applicable regulatory requirements and internal standard operating procedures (SOPs).
• Data Collection and Management: Oversee the collection and verification of clinical trial data. Collaborate with data management teams to ensure accurate and timely data entry.
• Documentation and Reporting: Maintain comprehensive and organized trial documentation. Prepare and submit accurate and timely visit reports as required by regulatory authorities and internal stakeholders.
• Risk Assessment: Identify and assess potential risks associated with clinical trial activities. Implement risk mitigation strategies to ensure the success of the trials.
• Training and Development: Provide training to investigative site staff on study protocols, procedures, and regulatory requirements.
• Collaboration: Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and medical affairs, to ensure alignment and successful execution of clinical trials.
• Quality: Communicate deviations from the protocol, SOPs, GCP, and applicable regulatory requirements to the investigator and ensure corrective actions are implemented.
• Participate in projects and/or initiatives identified by the Clinical Operations function or broader organization.

Education & Experience

• Bachelor's degree in a relevant scientific discipline; advanced degree is a plus.
• Proven experience of at least 5+ years as a Clinical Research Associate working for a Sponsor organization preferred.
• In-depth knowledge of Good Clinical Practice (GCP), regulatory guidelines, and industry standards.
• Strong understanding of clinical trial processes and the drug development life cycle.
• Excellent communication and interpersonal skills.
• Detail-oriented with strong organizational and time management abilities.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in using clinical trial management systems and electronic data capture platforms.

Knowledge, Skills & Abilities

• Highly motivated, agile, analytical, detail oriented, solutions driven and able to plan/organize/prioritize workloads to meet strict critical deadlines and project timelines.
• Proficient knowledge of Good Clinical Practice (GCP), ICH standards, and other applicable regulatory requirements.
• Strong understanding of clinical trial processes and the drug development life cycle.
• Demonstrated understanding of medical terminology and ICH-GCP principles and the application of those principles to trial planning and conduct of clinical trials
• Proven ability to communicate (verbal and written) clearly and effectively internally and externally with strong customer service.
• Ability to interact with KOLs, principal investigators and site staff with confidence, gain trust of customers and stakeholders.
• Ability to establish rapport and build lasting relationships.
• Strong site performance management.
• Ability to see the big picture and how responsibilities impact the project success.
• Ability to read, understand and follow all company SOPs and guidelines.
• Proficiency with Word, Excel and PowerPoint programs.
• Demonstrated knowledge of Clinical Data Management Systems, EDC and eTMF.
• Displays the ability to organize multiple priorities and deliverables
• Ability to manage expectations and deliver on timely requirements.
• Excellent verbal, written, and presentation skills are required

In addition to a talented and passionate team of colleagues and unparalleled science and technology, Neurotech offers competitive compensation, benefits through Blue Cross BlueShield and HealthEquity (FSA, HSA & HRA), a 401(k) through Fidelity with a company-sponsored match, generous vacation time and company holidays. We even cover the cost of 75% of your annualmedical plan deductible! And that’s just the beginning.

Do you share our vision?

To apply, please send a copy of your résumé to talent@neurotechusa.com.

Neurotech Pharmaceuticals 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.

Additionally, Neurotech does not accept unsolicited résumés or candidate profiles. If a candidate submitted in this manner is hired, no placement fee will be paid.