Clinical Research Director
Marketing | Agoura Hills, CA | Full Time
Message from the Hiring Manager:
"As Caldera Medical continues to grow in the medical device industry, we are actively seeking to add a Clinical Research Director to our ever-growing team. This position is a first for Caldera Medical and the right candidate must be comfortable starting up a Clinical Trials program. This position will be responsible to create the standards and guidelines for clinical research services and programs within the company. This role will provide leadership and manage all clinical trial activities. The Clinical Research Director will manage the clinical and scientific collaborations with investigators and consultants, the design inputs for the EDC and will participate in regulatory interactions to support submissions – all in a fast-paced environment."
Duties and Responsibilities:
- Manages study to achieve corporate milestones on time and on budget.
- Creates study design that meets FDA study requirements, develop clinical protocols and amendments, create investigator materials, annual reports, abstracts, manuscripts and clinical study reports.
- Develops suite of planning tools, including Study Oversight Plan, Clinical Monitoring Plan, enrollment plan, communication plan, contingency plan, start up and closure plan.
- Works with research sites to facilitate IRB approval.
- Updates study plans with forecasts, including but not limited to site start up, enrollment, and closure
- Tracks and reports study metrics (site and patient status, CRF completion, query status) against plan.
- Develops and implements study-specific monitoring and site training tools and oversees site training.
- Hires, trains and provides oversight of study and CRA’s to ensure overall study monitoring compliance
- Reviews and approves site visit reports.
- Provides oversight of Trial Master File submission and maintenance.
- Develops study and site budgets in collaboration with finance. Provides Finance with activity forecasts to allow for appropriate accrual.
- Reviews and approves invoices from investigators and service providers.
- Develops and fosters positive working relationships with colleagues, development and service partners.
- Acts as primary contact for all study activities.
Required Knowledge, Skills and Abilities:
- BS or Nursing degree required. Master’s Degree and/or ACRP-MDP certification is a plus.
- Eight-years of clinical research experience with a minimum of 3 years working for a company <$100M.
- Experience designing, leading and managing clinical studies. ACRP-MDP certification a plus.
- Knowledge of Good Clinical Practices, FDA regulations and guidelines and applicable regulatory requirements and relevant SOPs.
- Strong clinical/scientific/technical skills.
- Ability to anticipate and resolve problems effectively.
- Ability to exercise judgment within generally defined practices and policies for obtaining data.
- Experience working effectively in a fast-paced, team-based environment.
- Strong verbal communication and technical writing skills. Ability to present clearly using scientific and clinical terminology.
- Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings.
- Strong organizational, project management and follow-through skills with a focus on results.
- Attention to detail and the ability to prioritize.
- Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.
- Motivates team members; fosters and nurtures teamwork.
- Ability to work independently; self-directed and motivated.
- Travel is required (up to 35%).
Who is Caldera Medical?
Caldera Medical is a growth stage medical device company dedicated to improving the quality of life for women. We develop and market differentiated surgical implants specifically for the treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse. Our products are used by Urogynecologists, Gynecologists, and Urologists worldwide.
“Caldera is a small team of amazing, hardworking and dedicated people, who support one another on a daily basis.”
-Angela Attardo, Director of Talent Acquisition
Our Culture- Where Career and Passion come together!
- A Culture of family and team… not a corporate goliath where you’re just another number.
- All employees get a seat at the table and have influence with management.
- We care about giving back to the community. Our team donates time to helping local charities throughout Southern California.
- The Women’s Health Initiative is the heart of what we do, every day we put underprivileged women first.
- Our goal is to treat 1 million women suffering from incontinence by 2025!
Competitive Compensation, Comprehensive Benefits, and more!
- Medical and Dental Benefits – 75% paid for employee and family members
- Vision Coverage
- 401(k) with 4% matching contributions after 90 days of employment
- Basic Life and AD&D
- Unlimited Vacation Policy
- 6 Weeks Paid Maternity Leave
- 10 paid holidays- including your birthday!
- Being surrounded by amazing people!
Hear it from our very own! Learn more about Caldera on Glassdoor
Caldera Medical is an equal opportunity employer and considers all candidates for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.