The Lupus Research Alliance (LRA) is the largest non-profit organization leading the world in innovative research to improve the lives of those living with lupus today and to prevent and cure lupus tomorrow. The LRA organized a Lupus Clinical Investigators Network (LuCIN) to facilitate the clinical study of new and existing therapies to treat, cure, and ultimately prevent lupus. The LRA incorporated an affiliate, Lupus Therapeutics, LLC, to manage the business of affairs of LuCIN and the organization’s clinical trial endeavors.
The Lupus Therapeutics Grants and Contracts Analyst will be responsible for preparing, maintaining, and negotiating grants and contracts related to clinical trials and grants for LuCIN activities. The Analyst will support multiple projects across dozens of LuCIN sites. The Analyst must be able to independently work and within prescribed deadlines. Additionally, the Analyst will have the ability to present financial and legal considerations to collaborators to bring contracts to execution.
The position directly reports to the Lupus Therapeutics Executive Director and is based in the Washington DC metro area.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following:
- Build a coverage analysis by working closely with the Sr. Clinical Project Manager and Office Operations Manager to ensure billing compliance with all clinical trials in the LuCIN network.
- Build calendars for tracking of accounts receivable based upon the grants and contracts on each trial and site. Working closely with Office Operations Manager and Finance team on questions and concerns to assist with collection.
- Provide efficient updates on clinical trial and site progress to the Sr. Clinical Project Manager and Executive Director.
- Assist the study start-up process, including but not limited to conduct of the site selection/feasibility and finalization of site and Clinical Trial Agreements and grants.
- Ensure effective project plans are in place and operational for each trial and work proactively with the Sr. Clinical Project Manager to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), and regulatory requirements.
- Ensure potential budgetary and contractual risks are escalated to the attention of the Sr. Clinical Trials Project Manager and Executive Director when appropriate.
- Review and approve site invoices in collaboration with the Office Operations Manager to ensure investigator payments occur in a timely manner.
- Assist in follow-up business development activities as needed.
- Communicate effectively with LuCIN network leadership, clinical sites, investigators, and biopharmaceutical industry partners.
- Other duties as assigned.
Education/Experience: The ideal candidate will offer:
- Bachelor’s Degree
- Three to five years of budget monitoring experience with increasing levels of responsibility in the academic research, pharmaceutical, biotechnology, or CRO industry is required.
- Three to five years of budget and contract experience at an academic medical center, sponsor or CRO company is required.
- Exposure to the clinical research environment is required.
- Therapeutic experience in autoimmune diseases and/or Lupus (preferred).
- Experience in early phase trials (Phase I-II) (preferred).
Knowledge, Skills and Abilities:
- Read, write, and speak fluent English; excellent verbal and written communication skills.
- Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and data management methods.
- Critical thinker, self-motivated, and quick learner.
Work Environment: This is a high growth, fast paced entrepreneurial organization. The ability to be productive and successful in an intense work environment is critical.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.
Benefits: Company offers generous health, dental, vision, and life insurance coverage, at hire. After a 90-day probationary period, the flexibility to work remotely. Additionally, access to an on-site gym facility, as well as other building-related perks.
To apply please submit a cover letter, salary requirements, and resume. Resumes without a cover letter will not be considered.
No phone calls please.
For information about the Lupus Therapeutics, please visit our website: www.lupustherapeutics.org
Location/Region: Arlington, VA (22202)