Scipher Medicine develops innovative diagnostic tests to determine drug response and targeted therapies using our proprietary personalized medicine platform based on molecular technology. We hold a fundamental belief that patients deserve simple answers to their treatment plans using scientifically-backed data. Our platform allows us to interpret genomic data to gain unique insights into disease biology so patients with even the most complex diseases can achieve optimal health outcomes.
With only about 1 out of 3 rheumatoid arthritis (RA) patients adequately responding to anti-tumor necrosis (anti-TNF) therapies, the world’s largest selling drug class, we developed our flagship test, PrismRA™, to predict response to these drugs, thereby ensuring patients receive more effective therapies from day one. Scipher is transforming the traditional diagnostics business model by working closely with payers to change the way medications will be prescribed, saving both insurers and patients billions wasted in ineffective prescription costs. This is a unique opportunity to join a promising venture at an early stage to tackle some of the biggest problems in healthcare.
We are proud of our passionate, high-performance, mission-driven culture – one based on a set of values that are at the cornerstone of who we are and how we hold ourselves accountable. Founded in 2015, we are based in Waltham, MA and currently expanding across all functions within the organization. We are backed by Khosla Ventures, Northpond Ventures, Alumni Ventures and Tachyon Ventures and are well capitalized to execute our vision of launching a personalized medicine platform that transforms patients’ lives. Check us out at ScipherMedicine.com or follow us on LinkedIn.
The Role: The Clinical Trial Associate will be responsible for supporting clinical studies while effectively organizing and assisting in the start-up, implementation, management, and close-out of our clinical trials.
Overview: The Clinical Trial Associate (CTA) will support the Clinical Trial Managers and Clinical Operations team with all clinical trial related activities, from study start-up to close-out. Specifically, the CTA will be responsible for preparing and maintaining study documentation and tools, performing site feasibility and start-up, and managing the Trial Master File (TMF). The CTA will assist the Clinical Operations team in achieving study goals and ensuring compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all other applicable regulations.
Where: This position is located in Waltham, MA.
What will I do?
– Provide overall program support to the Clinical Operations team as well as liaise with other internal and external collaborators
– Assist with the QC, reviewing or drafting of study specific documents and plans such as Informed Consent Forms, site manuals, etc.
– Assist with the development of CRA, site training, and patient facing/recruitment materials, and ensure all study metric trackers, contact lists, checklists, and systems are up-to-date
– Assist with the development of the electronic Case Report Form by reviewing and/or providing input with clinical research, protocol, and site perspectives
– Assist with performing clinical monitoring visits
– Plan and facilitate study coordinator calls and requisite training
-Track clinical data entry expectations against monitoring activities and performance in preparation for data review meetings, data cuts, regulatory submissions, etc.
– Oversee maintenance of TMF, including ensuring files are inspection ready
– Communicate with CROs and study sites to drive successful trial completion
– Assist in the development of timelines, including tracking performance to forecasts
– Play a key role in the review of study specific data review
– Plan and organize study related meetings, taking detailed notes at meetings on decisions and action items, distributing the list to the team in the form of minutes
– Effectively communicate trial details to ensure that all team members are kept informed
– Properly elevate particular situations with understanding of action items and their impact on the present & future
– Participate in the development and review of SOPs
Minimum Education and Qualifications:
– Bachelor’s degree in a relevant field
– 3+ years’ experience within a Clinical Operations team is preferred
– Prior experience managing sites and being directly responsible for their performance at the sponsor level
– Experience in diagnostic development trials a plus
– Solid knowledge of Good Clinical Practice (GCP) and the Code of Federal Regulations (CFR) is required
– Broad knowledge in clinical monitoring activities, site management, and essential site documents
– Ability to work within a matrix team environment
– Strong communication skills, both written and verbal
– Ability to laugh at yourself
– 50% travel required
To all recruitment agencies: Scipher Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, or Scipher Medicine employees. Scipher Medicine is not responsible for any fees related to unsolicited resumes.
Scipher Medicine is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Scipher will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
IF INTERESTED IN EXPLORING THIS OPPORTUNITY PLEASE EMAIL YOUR RESUME TO CAREERS@SCIPHERMEDICINE.COM