Job Title: Clinical Trial Associate
Position Code: 2100170920
Location: Peloton Therapeutics, Inc.: Dallas, TX
Education: BA or BS, or AD and applicable work experience.
Career Level: Entry Level
Date Needed: November 2017
Job Type: Full-time/Exempt
Travel: Less than 20 percent (Domestic and International)
Peloton is dedicated to developing first-in-class, highly effective medicines for life-threatening diseases by leveraging great science, talented employees, and productive collaborations. We are seeking high-caliber individuals to join our growing team and contribute to our culture of collaboration, innovation, excellence, and shared sense of purpose. If you are passionate about improving patient outcomes, are driven to be the best at what you do, and are ready to make a positive impact, we invite you to apply to join our team. We offer an attractive compensation package including company ownership, competitive salary, comprehensive benefits, and the opportunity to be part of a dynamic biotech environment.
This is an exciting opportunity for a highly motivated individual to lead clinical study operations for novel small molecule cancer therapeutics while playing an instrumental role in the growth of an emerging and well-positioned biotechnology company.
This position is key contributor for the execution of clinical studies within agreed upon budgets, in accordance with applicable regulations, and in keeping with corporate goals. To deliver against these objectives, the successful candidate will work collaboratively with the Director of Clinical Operations and Medical Monitor, as well as with clinical study managers, internal teams, and external vendors.
- Assist with tracking study progress and maintaining study status updates (e.g. IRB approvals, regulatory document collection, patient enrollment, monitoring status, etc.)
- Develop agenda and draft minutes for study team meetings
- Track and prepare investigator and vendor budget payments
- Assist with the maintenance and QC of the trial master file
- Coordinate the preparation, collection, review and tracking of key clinical study documents (e.g. CDAs, financial disclosures, insurance certificates)
- Coordinate clinical study meetings (e.g. investigators’ meetings, advisory board meetings, etc.)
- Provide general administrative support for the study team(s) in the execution of the clinical trials (e.g. mass mailings, mass copies, meeting assistance, etc.)
- Four-year college degree, preferably in life/physical sciences or nursing; or Associates Degree with applicable experience with a CRO, pharmaceutical/biotechnology company, or clinical study site
- Minimum of 2 years of direct clinical research experience working with multi-functional teams
- Oncology experience preferred
- GCP and regulatory knowledge including FDA and ICH regulations
- Experience maintaining the required content of trial master files
- Strong organizational and priority management skills
- Excellent interpersonal and communication skills (both written and oral)
- Proficiency in Microsoft Office (e.g. Word, Excel, PowerPoint, and Outlook)
Hires Needed: 1
Wage Amount: Based on Experience
Company Contact: firstname.lastname@example.org
Peloton Therapeutics, Inc. is an oncology drug discovery and development company focused on advancing first-in-class small molecule therapies that provide patients suffering from life-threatening diseases with new therapeutic options. The company is driving forward multiple oncology programs targeting unexploited molecular vulnerabilities including adaptive processes that are induced in the tumor microenvironment by hypoxia, nutrient stress, and that result in evasion of anti-tumor immune responses. http://pelotontherapeutics.com