Senior Clinical Research Associate
- Olema Oncology
- San Francisco, California
- Start date
- Mar 9, 2023
- Clinical, Clinical Research, Regulatory
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Biotech Bay
Who We Are >>> Why You Should Work With Us
Olema Oncology (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) / selective estrogen receptor degrader (SERD), is in Phase 2 clinical development for the treatment of ER+/HER2- Breast Cancer. Our goal is to transform the standard of care for women living with cancer by developing more convenient and effective therapies.
Onto something bigger, together. Olema is made up of people who are passionate beyond measure. Each and every day, we come together to do amazing things – for each other, for science, and for women with cancer.
Strategically located in two large biotech hubs – San Francisco, CA and Cambridge, MA – we offer a flexible work environment and the best of both coasts.
Our modern hybrid workplace model encourages employees to split their week between working from home and at our lab/office, while also providing several allowances to help with both home office and commute expenses.
While at the lab/office, our teams build their camaraderie, opening the door for more authentic mentorship and career development opportunities. While at home, employees can make the most of their time – whether that’s picking up the kids from school, going on a mid-day run, or catching up on chores. Through this model, we strive to offer our employees the best of both work models.
About the Role >>> Senior Clinical Research Associate
As the Senior Clinical Research Associate reporting to a Senior Clinical Trial Lead 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 role is preferably based out of either our office San Francisco or Cambridge office and will require approximately 10-25% travel.
Your work will primarily encompass:
- Expanded scope on site management through review of monitoring schedules, metrics and visit reports. Participate in study site initiation visits and monitoring visits, including CRO oversight visits.
- Oversee the clinical operational conduct at the clinical sites.
- Interact and train the clinical site staff.
- Review/write informed consent forms.
- Participate in preparation of vendor requirements and project scope and selection of study vendors.
- Manage 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 systems, standards, and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance.
- Ensure compliance with the Clinical Monitoring Plan.
- Attend and lead CRA weekly meetings.
- 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.
- Develop study plans and participate in system set-up, and vendor training (e.g. UAT of EDC, IRT).
- 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.
- 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.
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.
- Bachelor’s degree required.
- Advanced site monitoring; study site management; and registry administration skills.
- Good knowledge of clinical research regulations and ICH-GCP.
- Demonstrated proficiency in Microsoft Word, PowerPoint, and Excel.
- 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.
- 5 years of pharmaceutical, clinical, or biological research experience.
- 3 years of experience working as CRA for CRO or in pharmaceutical setting.
- Experience monitoring oncology clinical studies is strongly preferred.
- 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.
- 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.
- Collegial, hard-working, confident, a self-starter and has a passion for results.
The base pay range for this position is expected to be $143,170 - $158,104 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.
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.
Olema also requires all employees to be fully vaccinated against COVID-19, subject to approved medical or religious exemptions or disability accommodations. The health and safety of our employees is important to us!
Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
We exist to develop therapies that offer the potential to improve outcomes for women living with cancer. We approach these goals with a single-minded focus.
At Olema Oncology, we leverage our deep understanding of endocrine-driven cancers, nuclear receptors and mechanisms of acquired resistance with the goal of transforming the standard of care for women living with cancer by focusing on developing more convenient and effective therapies. Join us as we aim to design therapies for improving lives.
Why Join Us?
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 and offer competitive compensation and benefits.
Olema seeks 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.
Located in Cambridge, MA and San Francisco, CA
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