Regional Sr. CRA/CRA | Oncology | Remote Based Role | Quickly Growing Biotech | Stock Options: RETAINED SEARCH
This is a newly created opportunity for an experienced CRA/Sr. CRA to join an attractive, stable, and fast-growing publicly-traded biotech company focused in Oncology. You will be the primary liaison between the Investigator sites and the Company, responsible for overall site conduct and establishing important relationships with key site personnel and serve as one of the faces of the Company to the sites. Given the smaller biotech environment, our client is seeking a candidate who is comfortable working in a hands-on, highly-visible and autonomous type of role, and who is flexible and can positively collaborate cross-functionally across all levels within the organization.
This is a very exciting time within the organization, as they have been growing across a number of departments, and this is a great opportunity to join a young and exciting company at the ground-floor and have the autonomy to truly impact the organization. This company has been attracting experienced and talented industry professionals and offers the “best of both worlds,” (i.e. small team comradery and nimble entrepreneurial environment where smart decisions are made quickly without red tape/bureaucracy, while also having the stability/financial backing of its parent company with deep pockets to fund its Oncology development and expand its Oncology pipeline too).
Location: This is a remote-based position where the individual can be located anywhere in western United States (ideally on the west coast).
Attractive Features about this Company & Opportunity:
- Visible and Impactful New Position: This is a very important and impactful newly-created role where you will utilize your monitoring/site management experience, as well as your experience building relationships with investigators, key site personnel, etc . This is a position where you will have the ability to truly impact the organization (unlike in Big Pharma).
- “Best of Both Worlds” (Biotech culture combined with stability and resources): The company offers all the attractive features sought with an entrepreneurial development/clinical-stage Biotech (small team comradery, impact, agility, quick decision-making, minimal bureaucracy) without the typical risks associated with a “startup.” Our client offers a flat organization structure with minimal layers of management, “red tape,” internal politics and bureaucracy which fosters more communications and swifter decision making (i.e. emphasis on progress and moving things forward).
- Excellent Compensation & Benefits: Our client will provide a very competitive compensation package, which will include a competitive base salary, double-digit annual bonus, stock options, unlimited vacation days, and industry-leading benefits. So you will get to share in the financial success of the company.
- Exciting Time to Join: Now is a perfect time to join this company while they are at the ground-floor and an exciting inflection point as they are advancing into Phase 3 with their lead compound to treat metastatic breast cancer.
- Great Culture & Forward Thinking Organization: A collegial, collaborative and forward-thinking culture where people are engaged, smart, enthusiastic, and passionate about making a real difference in the lives of cancer patients and their families.
- CEO’s Track Record of Success: The CEO has extensive leadership experience and an impressive track record of success in creating and building successful biotech companies that are focused on developing treatments for life-threatening and debilitating diseases.
- Perform site selection, initiation, monitoring and close-out visits of investigational sites for the Company’s oncology clinical trials.
- Manage the progress of assigned studies by tracking patient recruitment and enrollment, CRF completion and submission, source data verification, drug accountability, data collection, and data query generation and resolution.
- Oversee and conduct monitoring activities, including remote monitoring and risk-based monitoring.
- Develop collaborative relationships with investigative sites and personnel.
- Lead/manage assigned sites through regular contact to ensure site compliance, adequate enrollment, and understanding of study requirements.
- Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance.
- Build relationships with the Investigators and site staff to enhance productivity, as well as collaborate with management on protocol discrepancies, improving efficiency, data integrity, etc.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans.
- Prepare regulatory submissions, monitor patient safety and address protocol deviation, data quality issues, drug accountability and identify process improvements for assigned sites.
Education & Desired Experience:
- An advanced degree in a scientific or life sciences discipline is preferred.
- Experience monitoring oncology clinical trials is required. Phase 3 experience is preferred.
- 4+ years of relevant site management/ clinical monitoring experience working at a pharmaceutical/biotech company or CRO.
- Established a track record of building key productive relationships with study investigators, site staff and personnel, etc.
- Ability and willingness to travel up to 60-70% of the time as necessary.
Tom Fascia, Partner
firstname.lastname@example.org – P 973-656-0220 x717
Cornerstone Search Group, LLC
6 Campus Dive
Parsippany, NJ 07054
Keywords: Clinical Research Associate, Regional Monitor, Clinical Monitor, CRA, Clinical Site Manager, Clinical Site Management, Clinical Operations, Trial Management, Clinical Study Management, Oncology, hematology