The Clinical Research Associate (CRA) will be responsible for assisting the Clinical Operations team with clinical site, data, document, and trial management activities relating to study start-up, management, and close-out while ensuring continued compliance with the trial protocol, ICH/GCP, SOPs, and all applicable regulatory requirements.
Specifically, the CRA will be responsible for establishing and maintaining relationships with clinical sites, tracking trial metrics, conducting monitoring visits, reviewing data for completeness and accuracy, and overseeing the Trial Master File (TMF).
- Provide overall program support to the Clinical Operations team as well as liaise with other internal and external collaborators
- Assist in the creation and management of clinical trial documents, tools and plans such as informed consent forms, clinical monitoring plan, site training manuals, monitoring visit templates, regulatory documents etc.
- Assist with the development of the electronic case report form by providing review/input with clinical research, protocol, and site perspectives
- Support clinical site recruitment and qualification processes
- Ensure study contact lists, metric trackers, checklists, and systems are up to date
- Conduct initiation, interim, and close-out monitoring visits and draft all reports
- Maintain communication with clinical sites
- Perform in-house review of the clinical database for completeness and accuracy as well as compliance to the protocol and eCRF completion guidelines
- Establish and maintain the TMF by developing the TMF structure, overseeing document collection and filing, ensuring compliance with the TMF plan, and performing periodic QCs
- Collaborate with and oversee trial vendors
- Assists in the development of trial plans and budgets
- Participate in project meetings, draft meeting agendas and minutes
- Effectively communicate trial details to ensure that all team members are kept informed
- Escalate issues within the Clinical Operations team as needed
- Participate in the development and review of SOPs
Minimum Education and Qualifications
- Bachelor’s degree in a relevant field
- 3 plus years of clinical trial experience
- 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 GCP/ICH guidelines
- 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
- 75% travel required
About Scipher Medicine
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 and physicians to change the way medications will be prescribed, substantially improving patient outcomes while 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.