1 Clinical Trial Assistant Job in Boulder, CO
Edgewise Therapeutics is Hiring a Clinical Trial Assistant Near Boulder, CO
About Edgewise TherapeuticsAt Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.
We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!
About the Position:Edgewise is headquartered in Boulder, Colorado and this is an in-house position for a growing Clinical Development team. The assigned clinical studies will be highly complex and high risk, e.g., multiple indications, data monitoring committees, interim analyses, adaptive design, requiring the coordination of multiple vendors, or other special assessments. Candidate may be asked to provide support to clinical study lead for more than one study or across programs.
Essential Job Duties and Functions:
- Assist with study and site level tracking e.g., patient visits, invoices, and IRB submissions.
- Assist study team with patient enrollment activities and deliverables as required.
- Participate in country and site feasibility/selection process.
- Submit documents to Trial Master Files.
- Responsible for ensuring meeting agendas are clear and distributed in advance; take comprehensive and precise minutes for internal and external meetings.
- May participate in review of data listings to identify trends.
- May support the oversight of vendors at the direction of the study lead.
- May participate in the development of patient and site facing documents.
- Maintain internal Clinical Operations databases and document repositories.
- Assist with administration and management of site and vendor invoices, including invoice reconciliation for clinical operations.
- Assist with site start-up activities as required.
- Responsible for Coupa and Sirion requests related to assigned studies.
- May participate in the review of relevant study-specific plans and/or processes, as applicable.
- May participate in the review of database CRFs and user acceptance testing as required.
- Help with onboarding and mentoring of new department members.
- Adhere to Clinical Operations processes and SOPs.
- Read, understand, and comply with all workplace health and safety policies, safe work practices; and company policies and procedures.
- Perform other duties as assigned by supervisor.
Education, Experience, Skills:
- At least 1 years of relevant experience and a BS or BA (Life Sciences)
- Clinical trial experience in the pharmaceutical or health care industry or equivalent
- Excellent attention to detail, verbal, written, interpersonal and presentation skills are required.
- Must be familiar with routine medical/scientific terminology.
- Proficiency with MS Office
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
- Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision.
- High energy level, personal productivity, creativity, and commitment
- Team-player desiring to work in a fast-moving, dynamic start-up environment.
Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.
There is no deadline because the employer accepts applications on an ongoing basis.
Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.
Job Summary
Full Time
$58k-76k (estimate)
05/30/2024
06/27/2024
edgewisetx.com
Boulder, WY
<25
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The job skills required for Clinical Trial Assistant include Clinical Trial, Leadership, Clinical Operations, Presentation, Initiative, Commitment, etc. Having related job skills and expertise will give you an advantage when applying to be a Clinical Trial Assistant. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Clinical Trial Assistant. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Clinical Trial Assistant positions, which can be used as a reference in future career path planning. As a Clinical Trial Assistant, it can be promoted into senior positions as a Clinical Research Associate II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical Trial Assistant. You can explore the career advancement for a Clinical Trial Assistant below and select your interested title to get hiring information.
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