- Support the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with ICH/GCP guidelines.
- Assist/Oversee (when outsourced) the set-up of trials in relevant clinical trial systems (may include: TMF, CTMS, , EUDRACT etc.).
- Provides accurate and up-to date trial information within relevant tracking tools and provides regular updates of trial progression to the clinical trial team.
- Assist in the development of trial related plans and manuals.
- Ensures timely maintenance of the trial master file.
- Participates and ensures appropriate documentation of clinical team meetings.
- Managed vendor Pos and trial payments (including budget reconciliation), may include invoice review/approval.
- Assist in the set-up and management of clinical trial supplies (drug product, ancillary and other).
- Assist in external training activities (suppliers, clinical sites etc.).
- Assist in the management of trial completion activities, including data review, database lock and trial closeout.
- Humanity - We genuinely care about patients and about one another.
- Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
- Creativity - We are creative problem solvers.
- Collaboration - We are more than the sum of our parts.
- Curiosity - We have a growth mindset and push conventional thought and theory.
- BA/BS degree or an associate degree with at 3+ years of relevant experience.
- Excellent interpersonal, written, administrative and computer skills.
- Fluent in English (oral and written).
- General knowledge of drug development and ICH/GCP guidelines.
- Minimal (0-5%) travel required.
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Senior Clinical Trial Associate - Boston, United States - Entrada Therapeutics Inc.
Description
The Organization
What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.
Our Endosomal Escape Vehicle (EEV)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index.
Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, ocular, metabolic and immunological diseases, among others.
Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45 and 50 skipping amenable.
We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families.
You are patient focused and excited about the opportunity to help support and develop the Clinical Operations organization at Entrada.
You work successfully in a team environment with strong interpersonal skills to effectively build working relationships inside and outside the company.
The Opportunity
This individual will assist the Clinical Trial Lead and the clinical team in the day-to-day operations, set-up, execution, and closeout of assigned trials.
The individual is accountable to the clinical trial team for the support of trial execution and works collaboratively with cross-functional team members and vendors to ensure proposer set-up of trial processes and plans to execute the protocol in accordance with established SOPs and standards.
ResponsibilitiesAt Entrada, our passion for science, our devotion to patients and our values drives our behavior:
By becoming a team member here at Entrada, you'll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance.
Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer.
Entrada Therapeutics is an equal opportunity employer.Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.
Third Party Staffing AgenciesEntrada does not accept unsolicited resumes from any source other than directly from candidates.
For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position.
Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes.
Privacy StatementEntrada Therapeutics, Inc.
(the "Entrada," "we," "us," or "our") respects your privacy and we want you to be familiar with how we collect, use, share, or otherwise process, your Personal Information.
Please reference our privacy statement here to understand how and when your data is being used.
