Lightship is the virtual-first provider that is perfecting the way clinical trials get done. Because clinical research plays such a vital role in bringing life-enhancing and lifesaving innovations to market, Lightship pursues operational excellence to clinical studies. Our end-to-end hybrid delivery model, our diversity of skillsets, and inhouse care team ensure sponsor success and the best possible patient experience. With a problem-solving mindset, we strive to make every clinical trial better than the last. Operational excellence is not a goal, but a way of doing things at Lightship.
Clinical Study Start Up Associate (CSSUA) is familiar with Good Clinical Practice (GCP) standards and has an overall understanding of clinical trials. This individual possesses a strong background in successful end to end coordination of study start-up activities including, but not limited to, investigator screening and identification, pre-study development, site qualification, and site activation. The CSSUA works in a pivotal role requiring collaboration with internal and external stakeholders. This individual works closely with the Lightship clinical study team, other internal functional areas, study vendors and sponsors to manage the study start-up process.
Given Lightship’s distributed model and the remote nature of this position, the Clinical Study Start Up Associate possess a willingness and desire to work independently without significant oversight. Additionally, this position will require moderate travel – approximately 20%.
We would like to offer you:
- An opportunity to help re-envision how clinical research is executed with inclusivity, increased diversity and accessible at the core
- The chance to work with a patient-centered, clinically-oriented, collaborative team to support in the delivery of enterprise grade direct-to-patient clinical research solutions at scale
- An unmatched opportunity to grow as part of an early stage startup with industry veterans, high-caliber investors, and a massive market opportunity
- Competitive compensation
Generous benefits package, including:
- Top notch healthcare (medical, dental, and vision) for you and your family.
- Unlimited Paid Time Off (PTO), plus paid holidays and bereavement to help support work life balance.
- A 100% 401(k) company match for up to 4% of eligible contributions with an immediate vesting.
- Generous paid parental leave
- Short & long-term disability
- Life insurance and More!
Clinical Study Start Up Associate is responsible for:
- Assisting with identification, selection and on-boarding of research sites/investigators.
- Working with the current network of sites to complete feasibility and study start-up activities for new projects.
- Communicating forecast timelines for site activation and ensuring all activation requirements are met
- Ensuring the study site is in compliance with all local and federal laws and regulations
- Preparing, reviewing, and maintaining essential regulatory documents
- Setting up and maintaining the Investigator Site File (ISF)
- Assisting with ICF review and negotiations
- Preparing and managing site level IRB submissions/activities and confirming IRB approval is received and documented.
- Determining site readiness to support shipment of clinical supplies and investigational products
- Supporting the Clinical team with identification, contracting, and management of vendors
- Identifying and escalating issues regarding site activation before they become critical; assisting in identifying appropriate paths to resolution and implementation
- Other duties as assigned
Clinical Study Start Up Associate has:
Required knowledge, skills, and abilities:
- Experience with clinical trial management systems and electronic data capture
- Experienced with IRB submissions and tracking
- Thorough knowledge of ICH /GCP guidelines
- Ability to work cross functionally
- Ability to maintain flexibility and adapt in a fast-paced environment
- Ability to prioritize and successfully manage multiple tasks and conflicting priorities
- Exceptional attention to detail
- Exemplary time management and organizational skills
- Strong written and verbal communication skills
- Software skills: web and computer skills, including advanced knowledge of Microsoft Office Suite
Education and experience:
- 2+ years in end-to-end study start-up capacity or equivalent required
- BA/BS degree required; health related degree preferred
- Prior forecasting experience
- Prior experience with ICF negotiation via tracked changes
- Prior experience with contract negotiations
- Bilingual abilities are a plus o Requisite combination of education, training, and study start-up experience
Our commitment to diversity & inclusion:
Lightship is an equal opportunity employer and promotes a diverse and inclusive workplace. Lightship considers all applicants without regard to race, color, religion, creed, national origin, age, sex, marital status, ancestry, disability, veteran status, gender identity, genetic information, sexual orientation, or any other status protected by applicable law. EEO is the Law
Please note: For the safety of our patients and each other, all positions at Lightship that require travel, in-person participation, or are patient-facing, do require vaccination against COVID-19.
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