Job Description:
About Us
We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our surgical & sports medicine products support the healing of musculoskeletal injuries and degenerative conditions. Our strength is giving others strength.
Learn more about Careers at Organogenesis
What You Will Achieve:
The Clinical Trial Associate I/II will provide in-house administrative support of clinical trials and Clinical Operations staff by providing continuity of workflow between Investigative Sites, Clinical staff and outside consultants/vendors. Provides support for clinical trial management function. Manages document, supply, payment and sample tracking systems; works closely with Clinical Program Managers (CPMs) and Clinical Research Associates (CRAs) to execute and manage clinical trials.
Responsibilities include administrative support for the Clinical Operations department. The Clinical Trial Associate I/II must be able to manage several tasks and projects simultaneously. This position will be responsible for performing diverse responsibilities requiring sound judgment, problem solving skills and a working knowledge of all study-specific protocols.
How You Will Achieve It:
- Develop/manage clinical trial tracking and reporting systems/tools
- Update/maintain electronic copies of documents/templates used for clinical trial management and department operations
- Create/prepare clinical trial tracking/status reports,
- Assist in preparation/formatting/finalization of clinical study documents, contracts and related attachments, reports, meeting minutes and correspondence
- Prepare/provide binders to clinical site for training at study initiation and collection and maintenance of study-specific documents during study conduct. Provide updated documents to site as required.
- Collect/review/track site regulatory documents
- Serve as primary/secondary contact for investigational site and vendor personnel as delegated
- Prepare/maintain study-specific Trial Master Files (TMF). Periodically review TMF content to ensure completeness
- Manage clinical supply (re)order process and inventory. Respond to (acknowledge receipt/fill) order requests in a timely manner.
- Participate in project specific meetings and coordinate department meetings
- Maintain department calendars and perform other administrative duties as needed
Job Requirements:
What You Need to Achieve It:
- Previous experience of at least 3-5 years in Clinical Research, Clinical Affairs or Clinical Operations or industry preferred. Biologics and/or medical device experience a plus
- B.S. in scientific discipline (Biology, Biological Sciences, Biotechnology)
- Experience with Microsoft Office applications
- Working knowledge of GCP/ICH/CFR regulations for conduct of biologic and/or medical device clinical trials.
- Strong organizational, interpersonal and communication skills
- Ability to handle multiple tasks and projects simultaneously
- Willingness to travel as needed (minimal, up to 4 days per quarter
What can we offer you?
401k
- - generous employer match with immediate vesting and financial planning resources
- Comprehensive Medical, Dental and Vision coverage options effective on day one of employment
- Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account
- Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options
- Paid maternity leave and parental leave for all new parents
- Adoption benefits
- Education Assistance Policy - $5,000 per year for all employees
- Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more
- Employee Assistance Program
- Generous paid time off including vacation, floating holidays, sick days, and company holidays
- Free parking including an electric charging station (Canton and La Jolla)
- Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint
The anticipated annualized base salary for a Level I role is $69,000 - $87,000 and for a Level II is $83,000 - $104,000 and reflects current market data for similarly-sized life science companies and internal equity. Organogenesis is a multi-state employer, and this salary range may not reflect positions that work in other states. Base salary is part of our total rewards package which also includes the opportunity for merit-based increases, eligibility for our 401(k) plan with competitive company match, medical, dental, vision, education assistance, life and disability insurances and leaves provided in line with your work state and federal law. Our time-off policy includes paid vacation days, paid company holidays, and paid sick time. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education, and other factors permitted by law.
We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law.
We do not accept unsolicited agency resumes and we are not responsible for any fees related to unsolicited resumes.
