Clinical Study Start-Up Specialist
The Clinical Operations team at Moderna is looking for an agile, self-motivated, and experienced individual to provide start up support across new clinical trials. This position will ensure clinical documents are prepared, deployed and reviewed in a timely manner to sites are able to be supported during the most complex and time dependent portion of the study. The majority of this work will be done in collaboration with internal partners and executed at external contract research organizations (CROs). The successful candidate will be skilled at understanding the needs of the sites with attention to detail with a positive and collaborative outlook and with the ability to manage workload to meet project timelines.
Here's What You'll Do:
- Collect, review, process, and track regulatory start up documents required for effective and compliant study site activation
- Ensure that all assigned start up activities are on track and support study deliverables
- Proactively manage sites to ensure timely site activation
- Escalate study issues appropriately and in a timely fashion
- Provide accurate projections and timelines to study teams
- Review site informed consent forms
- Review and update study documents when there are changes in study personnel/study protocol amendments
- Liaise with Moderna Regulatory department regarding document submission requirements
- Support submissions to site review committees including SRC, IRB/IEC and IBC
- Can include support to negotiate site contracts and budgets with sites
- Proactively track progress of start up milestones/developments, intervening and escalating as appropriate
Here's What You'll Bring to the Table:
- Bachelor's degree in a life science or allied health discipline (e.g. nursing, medical or laboratory technology)
- At least 3 years experience in clinical research
- Strong written and oral communication skills
- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements
- Familiarity with investigator start-up documents and contract/budgets negotiation process
- Strong organizational/prioritization skills for the management of multiple concurrent projects with attention to detail a must
- Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint), [and specific clinical research tools/applications?]
- Successful candidate will be curious in exploring new path for clinical research, bold in proposing creative solutions and ideas. Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes
Here's What We'll Bring to the Table:
- Daily on-site catered lunches
- Company-provided iPhone
- Free parking, monthly subway pass, or a subsidized commuter rail pass
- Highly competitive healthcare coverage. Including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
- Flexible Spending Accounts for medical expenses and dependent care expenses
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately.
- A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale, and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.