Harbinger : Clinical Trial Associate

Clinical Trial Associate

Harbinger Health, a Flagship-founded company, is pioneering early cancer detection. Harbinger aims to detect cancer, at the earliest stages, to save lives. Our platform leverages proprietary biological insights and artificial intelligence to enable high-resolution, molecular views on cancer from blood. We are a highly dynamic, entrepreneurial, and innovation-driven organization seeking collaborative, passionate, and dedicated people to join our team.

Flagship Pioneering conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in more than $200 billion in aggregate value. To date, Flagship has deployed over $2.5 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 42 transformative companies, including Axcella Health (Nasdaq: AXLA), Codiak BioSciences (Nasdaq: CDAK) Denali Therapeutics (Nasdaq: DNLI), Evelo Biosciences (Nasdaq: EVLO), Foghorn Therapeutics (Nasdaq: FHTX), Indigo Ag, Kaleido Biosciences (Nasdaq: KLDO), Moderna (Nasdaq: MRNA), Omega Therapeutics (Nasdaq: OMGA), Rubius Therapeutics (Nasdaq: RUBY), Sana Biotechnology (Nasdaq: SANA), Seres Therapeutics (Nasdaq: MCRB), and Sigilon Therapeutics (Nasdaq: SGTX).

Responsibilities

• Under the direction of Clinical Trials Leadership, this position will assist in the design, development, implementation, and conduct of an effective monitoring program in accordance with Good Clinical Practice, institutional policies and procedures, and research protocols. The Clinical Trials Associate and Monitor will ensure that, for those clinical trials assigned for monitoring, the appropriate and required monitoring tasks and related activities occur as outlined in the monitoring plan and in compliance with all related regulatory standards.

 

• The CTA will verify that trial data entered on the Case Report Form is consistent with patient clinical notes and other source documentation (source data verification), independently coordinate upcoming and ongoing monitoring assignments while meeting expected timelines for completion of monitoring activities and submission of written monitoring reports and assist in the development and writing of clinical trial monitoring plans. Monitoring will be performed through a combination of remote data review and potential onsite monitoring visits; therefore, a willingness and ability to travel occasionally is required.

 

•  In addition, the CTA/Monitor will participate in site feasibility/selection process and will communicate clearly and thoroughly with CROs. The individual will help coordinate, guide, and assist with start-up activities, budget/contract negotiations, and study document revisions, as well as administration tasks associated with running a successful trial. The CTA/Monitor will track metrics and study start-up timelines to identify trends and opportunities for improvement, track and report on study progress including site activation, patient enrollment, monitoring visits, review site visit reports for accuracy, quality, and consistency. The Clinical Trials Associate is responsible for multiple projects at a time and must have strong time management skills in addition to working both independently and in a team environment.

Qualifications

• Bachelor's degree in a field relevant to research compliance 
• 3+ years of progressively responsible clinical trials experience with 1+ years of monitoring experience.
• Knowledgeable of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.

 

Flagship Pioneering and our ecosystem companies 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.

Recruitment & Staffing Agencies:  Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates.  The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team.   Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe