Job Description
This role is considered Hybrid.
Overview
The Clinical Trial Associate is a highly motivated person with excellent computer skills, who is highly attentive to details, has strong organizational skills, and able to communicate effectively in a fast-paced environment. Major responsibilities for this position include maintenance of informational databases and program tracking reports, participate in coordination of clinical trial related activities, authoring of study operations manuals, and providing general program support in a team setting to ensure the successful execution of clinical trial tasks and deliverables according to project timelines. Duties may include, but are not limited to, subject tracking, assembly, review, quality control, and tracking of regulatory documents, maintenance and tracking of study materials (including investigational drug), generation and distribution of meeting agendas and minutes in addition to other activities.
Summary of Key Responsibilities
- Effectively and efficiently interact with internal, clinical site and vendor personnel.
- Have the interest and ability to expand knowledge of clinical trial management proceduresand regulatory submission requirements.
- Learn health care authority regulations and guidelines, and apply to daily activities.
- Perform day-to-day activities based on Standard Operating Procedures and Good Clinical Practice (GCP).
- Learn and execute defined tasks while working closely with others.
- Assist with in-house coordination of activities related to conduct of clinical trials.
- Demonstrate problem-solving skills, including the identification of problems and proposed solutions, in consultation with more senior team members.
- Possess good verbal skills and seek information when needed.
- Seek opportunities to learn and be receptive to constructive feedback.
- Benefit from close supervision but be willing to work independently.
- Receive guidance on clinical development process and the role operations plays in that process.
- Track progress across multiple programs and communicate this to internal and external stakeholders.
- Organize trial and program related team meetings, associated agendas, and generate meeting minutes, including tracking of action items.
- Become familiar with and assist in maintaining clinical invoice tracking and other budget databases for multiple projects, generate periodic reports on status of payments and other database reports, and resolve payment inquiries from investigator sites.
- Maintain other informational databases for clinical trial status throughout the life of a clinical program.
- Train to monitor clinical sites / data under the direction of experienced clinical research personnel through co-monitoring visits.
- Travel as needed, although requirements are minimal (less than 20% for non-monitoring related work; potential at times for up to 50% for monitoring related travel).
Qualifications
- BS/BA degree in healthcare / scientific field preferred
- Demonstrated work experience in related field
- Some experience working in a contract research organization and/or clinical trial environment is preferred
- Entry level is acceptable
About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.
Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.
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Job Tags
Contract work, Work experience placement,