Senior/Clinical Research Associate

Location
San Francisco, California
Posted
May 14, 2022
Ref
4519931004
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Olema Oncology (NASDAQ: OLMA) is a biopharmaceutical company developing innovative targeted therapies for women’s cancers.  Our lead program, OP-1250, a potential best-in-class complete estrogen receptor antagonist (CERAN), is in development to treat estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Olema recently initiated a Phase 1/2 dose-escalation and expansion clinical trial of OP-1250. We are supported in our mission by experienced and accomplished scientists and board members, leading healthcare investors, and some of the most innovative pharma companies. For more information about the company please visit www.olema.com

The Role:

We are looking for a talented and driven Senior/Clinical Research Associate (Sr/CRA) for our growing Clinical Operations team. The Sr/CRA is responsible for assisting the Clinical Trial Manager in managing and/or leading the day-to-day operations of assigned study execution tasks to ensure completion per established project team goals and objectives. The Sr/CRA will work closely with a cross-functional team in a fast-paced, high growth, team environment to ensure that clinical trials are conducted on time and budget, and in accordance with applicable GCP/ICH guidelines and other regulatory requirements.

This is a fantastic opportunity for a hands-on Sr/CRA to join a company with an industry leading Board of Directors and Management team, and roll up their sleeves to build an innovative women’s oncology company with significant potential to transform breast cancer treatments.  

This position will be based in the San Francisco Bay Area.

What You Will Do:
  • Participate in preparation of vendor requirements and project scope and selection of study vendors
  • Manage vendors to ensure timely and quality deliverables
  • Provide study progress updates to CTM and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
  • Provide monitoring oversight through review of monitoring schedules, metrics and reports
  • Participate in study monitoring visits, including CRA oversight visits
  • Participate in and, if appropriate, facilitate cross-functional study execution team meetings; liaise with other functional areas to coordinate clinical study activities
  • Implement appropriate systems, standards, and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance
  • Develop study plans and participate in system set-up (e.g. UAT of EDC, IRT)
  • Participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
  • Review clinical study plans, reports, and study metrics
  • Participate in study feasibility assessments and selection of countries and sites for study conduct
  • Participate in creation and conduct of study-specific training at investigator meetings
  • All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with Olema SOPs

What You Will Bring:

  • Bachelor’s degree required
  • 5 – 8 years of experience working with CROs to manage clinical trials in US and globally
  • Substantial Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
  • Experience independently managing vendors (e.g. imaging, central lab, etc.)
  • Comfortable working with different levels of the company including senior level management
  • Experience working in a self-driven capacity, with a sense of urgency and limited oversight
  • Demonstrated proficiency in Microsoft Word, PowerPoint and Excel

Personal Characteristics:

Given the “small biotech” nature of the Company, cultural fit of the successful candidate is an important criterion for their success at Olema. Desired characteristics include a high level of curiosity, intelligence, ability to work independently, “can do” attitude, and ability to work cross-functionally. Strong initiative and follow through are essential for this job.  

Specific personal characteristics include:

  • Excellent verbal and written communication and skills
  • Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
  • A commitment to excellence
  • Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization
  • Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
  • Entrepreneurial mindset and the ability to prioritize key workstreams and requirements that will change over the near and mid-term
  • Be a “difference maker” in terms of one’s professionalism and contributions
  • Have impeccable professional ethics, integrity and judgment
  • Be collegial, hard-working, confident, a self-starter and have a passion for results
Additional Information:   We require all employees to be fully vaccinated against COVID-19, subject to approved medical or religious exemptions or disability accommodations.   We believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated. We provide equal opportunity to all employees and applicants for employment.    Olema offers competitive compensation and benefits. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with a platform to develop their long-term careers.   Please note: Olema does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.