Clinical Research Associate II/III
Seer is building a world-class team of experts passionate about developing cutting-edge technologies. We are rapidly growing a diverse team that is committed to pushing the limits of proteomics to discover new insights into biology and improve the lives of patients. Do you have the drive and talent to solve challenging questions as a member of a high-performance team? Do you enjoy travel and value a team-oriented company culture?
The Role & The Team
Reporting to the Associate Director of Clinical Operations, we are seeking a temporary Clinical Research Associate II or III to join our Clinical team. The project is anticipated to last 1.5 years and the role is based remotely, with a preference for candidates based on the East Coast. The CRA will regularly travel to various clinical sites across the country and will work closely with their team members located in Redwood City, CA and Chicago, IL.
Seer’s new CRA II/III will have a demonstrated history of success in site management and monitoring clinical activities. The ideal candidate will have significant clinical trial experience and a track record of accomplishments in the life sciences/pharmaceutical/biotechnology industry. This role requires the ability to communicate effectively with study investigators and staff, to manage projects independently, and to manage multiple projects simultaneously.
Responsibilities & Goals
Areas of specific responsibility and attention will include:
- Contribute to development of study project plans and critical study documents, including informed consent forms, case report forms, required sample collection, and handling protocols and site training materials
- Contribute to development of study project plans
- Perform site identification, qualification, and startup activities, including regulatory document review, IRB submission, and document review, and ensure timely shipment of study supplies, including regulatory binders and sample collection supplies
- Work with vendors to ensure that all study services comply with the study plan and budget; this may include clinical research organizations (CROs), electronic data capture vendors (EDC), and suppliers
- Implement initial and ongoing site training in the conduct of the study, as well as the sample collection and handling procedures
- Perform ongoing site management activities, including assessing adherence to eligibility criteria, sample collection and handling instructions and other study procedures, identifying and implementing a plan for retraining or ongoing training needs, ensuring that sites have continuous sample collection supplies, and facilitating ongoing communication
- Perform data management activities, which includes generating queries and documenting their resolution in a manner consistent with established timelines
- Execute all site monitoring activities; ensure subject informed consent and eligibility, data quality and integrity and adherence to applicable regulations
Background & Qualifications
The ideal candidate for the temporary CRA II/III role will have had significant study monitoring and site management experience, as well as experience communicating with clinical study site investigators and staff.
Candidates must bring a strong entrepreneurial orientation along with teamwork skills and an absolute commitment to competing with the highest level of integrity.
Key requirements include:
- Bachelor’s Degree required (life science preferred) or certification in a related allied health profession such as nursing, medical or laboratory technology
- Minimum of 2 years of experience as a Clinical Research Associate
- Ability to travel up to 70% of the time and throughout the US
- Experience working remotely and ideally based on the East Coast
- Availability for the duration of the project (up to a 1.5 year period of time)
- Knowledge of GCP, ICH guidelines and regulatory requirements for clinical study management
- Understanding of study-specific clinical specialty and standard of care/patient management within that specialty
- Experience monitoring studies for diagnostic product development
- Ability to work independently with minimal supervision
- Ability to communicate effectively with clinical study site investigators and staff, and with internal teams
- Excellent Microsoft Office (Excel, PowerPoint, Word), project management and clinical trials software skills
- Strong written and oral communications skills, with demonstrated experience in cross-functional and timely communication
- Strong and collaborative work ethic; must be a self-starter and persistent in achieving objectives to support Seer’s scientific and business goals
- Must work well in a small team setting, with ability to work independently and collaboratively, while meeting scheduled deadlines in a fast-paced environment
- Highly organized, exceptional attention to detail, and strong proficiency in documentation skills
We encourage you to submit your resume below or send to Careers@seer.bio. We look forward to hearing from you!
Seer is an equal opportunity employer that values diversity and inclusion. All applicants will be considered for employment without attention to race, color, national origin, religion, gender, gender identity, sexual orientation, age, marital status, veteran status, or disability status.