- Monitor drug and ancillary supplies and place orders with the central depot to ensure adequate stock at sites
- Consolidate dosing data from electronic source to ensure patient dosing compliance
- Monitor clinical trial Insurance and license agreements across studies and work with vendors to ensure current agreements
- Manage internal process for approval of contracts, purchase orders and invoices
- Facilitate shipment of various samples defined in the protocols to third party labs
- Manage postings
- Manage translations of study documents
- Develop and maintain internal and external trackers
- Assist in the development of study documents, including study and lab manuals
- BA/BS in life sciences or related area
- 1-2+ years clinical research experience in a CRO, hospital or industry
- Knowledge and training on GCP
- Ability to work in a fast paced, matrix environment
- Outstanding organizational skills and detail oriented; ability to track detailed information
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Clinical Trial Associate - Boston, United States - Rhythm Pharmaceuticals
Description
Company OverviewRhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Opportunity Overview
As a Clinical Trial Associate, you will be responsible for providing operational support to Phase 1 through Phase 3 studies of setmelanotide in genetic obesity. This position will work closely the individual study leads to ensure key deliverables are met for each of the studies. This is an opportunity to work across multiple phases of development on global studies and have a direct impact in helping Rhythm achieve important corporate milestones.
Responsibilities and Duties
More about Rhythm
Our lead asset, IMCIVREE (setmelanotide), is a precision medicine designed to treat hyperphagia, an insatiable, pathological hunger characterized by abnormal food-seeking behaviors, and early- or rapid-onset severe obesity caused by an impairment of a pathway in the hypothalamus called the melanocortin-4 receptor (MC4R) pathway. IMCIVREE is the first and only approved therapy for certain rare MC4R pathway diseases in the United States, Europe, Great Britain and several other countries. In collaboration with leading experts across the world, Rhythm is advancing the most comprehensive clinical research program ever initiated in MC4R pathway diseases, including a Phase 3 trial for acquired hypothalamic obesity. In addition, we are leveraging our extensive genetic database, global network of researchers, a track record of regulatory successes and global commercial infrastructure to develop a full portfolio of treatment options to patients struggling with hyperphagia and severe obesity and ensuring they get the treatment that is right for them.
We continue to advance care and precision medicines that address rare diseases. We are focused on expanding access to IMCIVREE to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. Rhythm's headquarters is in Boston, MA.
