Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at
www.olema.com.
About the Role >>> Senior Clinical Research Associate
As the Senior Clinical Research Associate (Sr CRA), reporting to a Director, Clinical Operations, you will oversee trial site conduct and manage and/or lead the day-to-day operations of assigned study execution tasks to ensure completion per established project team goals and objectives. You 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 oncology company with significant potential to transform breast cancer treatments. This role is based out of either our San Francisco or Cambridge office and will require approximately 10-25% travel.Your work will primarily encompass:
- Oversee site monitoring and the clinical operational conduct at the clinical sites.
- Participate in/oversee study site selection, site initiation, and interim monitoring, site closeout, and/or co-monitoring visits (internal and/or CRO).
- Review/assess monitoring schedules, metrics and visit reports.
- Ensure compliance with the Clinical Monitoring Plan.
- Create/participate in the creation of SIV, investigator meeting, and other study training materials, and interact with and train clinical site staff and/or CRAs.
- Review/write informed consent forms.
- Manage select vendors to ensure timely and quality deliverables. Develop trackers for sample management.
- Manage recruitment and enrollment metrics, provide weekly study updates and slides for Clinical Development.
- Implement appropriate 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) and vendor training.
- Provide study progress updates to CTL and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
- Participate in and, if appropriate, facilitate cross-functional study execution team meetings; liaise with other functional areas to coordinate clinical study activities.
- Participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables.
- Review/write clinical study plans, reports, and study metrics.
- All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with Olema SOPs.
Ideal Candidate Profile >>>
A love of challenging, important work.
We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.Knowledge:
- Bachelor’s degree required.
- Good knowledge of clinical research regulations and ICH-GCP.
- Demonstrated proficiency in Microsoft Word, PowerPoint, and Excel.
Experience:
- 5 years of pharmaceutical, clinical, or biological research is required, with at least 2 years in a pharmaceutical/biotech sponsor company preferred.
- 3 years of experience working as site monitor for a CRO or in pharmaceutical/biotech setting.
- Experience monitoring/overseeing the monitoring of oncology clinical studies with demonstrated longevity within specific oncology clinical trial(s).
- Substantial site management experience or equivalent experience in clinical research, with an understanding of clinical trials methodology and terminology.
- Experience independently managing vendors (e.g. imaging, central lab, PK labs, ECG, 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.
Attributes:
- Proven ability to gain in-depth protocol knowledge.
- Ability to perform all clinical monitoring activities independently.
- Strong initiative and follow-through.
- Excellent verbal and written communication 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.
- Be a “difference maker” in terms of one’s professionalism and contributions.
- Have impeccable professional ethics, integrity and judgment.
The base pay range for this position is expected to be $145,000 - $155,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.#LI-CK1
Important Information
>>>
We provide equal opportunity to all employees and applicants for employment and 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 offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes.
Thank you.
Additional Note/Fraud Alert: Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs,
please be vigilant in checking that the communication is in fact coming from Olema.
