- Job Type: Full-Time
- Function: Clinical Research
- Industry: Biotechnology
- Post Date: 05/22/2023
- Website: www.escientpharma.com
- Company Address: 10578 Science Center Drive, Suite 250, San Diego, CA, 92121
About Escient PharmaceuticalsEscient Pharmaceuticals is a provider of bio-technical research and development services intended to focus in advancement of first-in-class G Protein-Coupled Receptor targeted drugs. The company's services focuses on offering therapies for neuro-immuno-inflammatory and autoreactive diseases, enabling its clients to receive drugs required fortreatment of serious, unserved medical needs across a broad range of therapeutic indications.
Escient Pharmaceuticals is a San Diego based a clinical-stage company focused on developing novel therapeutics to address a broad range of neurosensory-inflammatory disorders. The company’s pipeline includes two first-in-class small molecule antagonists targeting MRGPRX2 for the treatment of various mast cell mediated disorders and MRGPRX4 for cholestatic pruritus. Escient is led by an experienced management and scientific team and funded by top-tier life science investors.
Our team is driven by the desire to make a positive difference in the lives of patients. We are passionate about innovative science and strive to discover and develop novel medicines, to bring value to the healthcare ecosystem, and to address significant unmet medical needs. We foster a culture of innovation, collaboration, transparency, mutual respect, and integrity and an environment where employees feel fulfilled by the work they do and are recognized for the contributions they make.
Escient is seeking a dynamic, creative and highly motivated individual for the position of Senior Clinical Trial Associate (Sr. CTA) to work closely with the Clinical Operations study lead(s) to support all activities involved with clinical trial planning and execution. The Sr. CTA will work cross functionally with the internal team as well as with study sites, CROs and other vendors.
To be considered, candidates must be able to work in a fast-paced environment with drug development professionals and be able to respond to changing priorities in a thoughtful, creative manner. This is a hybrid position that requires working onsite at the San Diego corporate office 1 -2 days per week. Travel will be required to the extent necessary for oversight of vendors (anticipated 5-10%).
Primary responsibilities include:
- Performing assigned tasks in support of planning, quality execution and delivery of clinical trials
- Collaborating with the Clinical Operations study lead (or other team members) on the development of certain study specific plans and processes
- Participating in study specific tasks such as Investigator identification, collection of essential documents and site activation
- Developing and maintaining good working relationships with Investigators and study staff
- Assisting with the tracking and management of study specific budgets including review of invoices against contract
- Developing and maintaining study trackers and providing metrics as needed
- Participating in user acceptance testing (UAT) of clinical systems, including EDC and interactive response technology (IRT)
- Helping manage study vendors and vendor budgets/contracts
- May also help evaluate CROs/vendors, including developing budget assumptions, and reviewing proposals and contracts
- Assisting in the organization and planning of Investigator Meetings and other training meetings
- Contributing to the development of the Monitoring Plan and assisting with ensuring appropriate quality and timely monitoring of clinical sites
- Assisting with review of Site Visit Reports to monitor for quality, consistency and adherence to the Monitoring Plan
- Participating in co-monitoring activities and oversight of CRO or contract CRAs for site monitoring visits as needed
- Supporting TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents
EDUCATION AND QUALIFICATIONS
- BA/BS degree in related discipline and a minimum of 4 years of related experience
- Clinical operations experience in phase 1 to phase 3 clinical trials including global clinical trials
- Understanding and ability to ensure adherence to SOPs, ICH/GCP, and FDA and other health authorities’ regulations with strong understanding of inspection readiness
- Strong initiative and desire to work in a fast-paced team-oriented, and dynamic environment
- Creativity and flexibility in problem solving; ability to work collaboratively as part of a team
- Highly accountable for the results and outcomes of responsibilities and understands the impact of their efforts
- Excellent written and verbal communication skills and proven ability to multitask
- Efficient time management and strong organizational skills. Attention to detail and quality are critical to success in this role.
If you thrive in a fast-paced, entrepreneurial environment and are in search of a dynamic, multi-disciplinary team focused on discovering and developing therapies that will positively change the course of the health and well-being of underserved patients, we encourage you to apply. Escient Pharmaceuticals offers a positive and exciting work environment with competitive pay structures and benefits. Escient is an equal opportunity employer.
Escient Pharmaceuticals, Inc.’s Human Resources team manages its own recruitment and employment process. To protect the interest of all parties involved, Escient will only accept resumes from a recruiter if an executed search agreement is in place at the start of the recruitment effort for a particular open position. Unsolicited resumes sent to Escient from recruiters do not constitute or create any type of relationship between the recruiter and Escient, and Escient shall not pay any fees should we hire any individual from those resumes. Recruiters are requested not to contact or present candidates directly to Escient’s hiring manager or employees.