Clinical Trial Assistant
Clinical Trial Assistant
Location: Cambridge MA
The Clinical Trial Assistant is responsible for assisting the study team in running the day to day operational activities of clinical studies. The individual will be responsible for the coordination, tracking and management of daily activities for multiple clinical studies to support both the internal team and CROs. The company is focused on indications related to anemia, oncology, and vascular development. Each indication will be developed in clinical studies performed on a global scale in coordination with international Clinical Research Organizations.These studies will be submited to health care regulatory authorities around the world such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This position will report to the Manager of Project Coordination.
Functions and Duties
- Protocol review to ensure seamless integration between clinical objectives and study performance.
- Works directly with internal clinical lead and internal and external medical experts to optimize and implement clinical studies.
- Participate in CRO review, selection, and negotiation for each study.
- Leads interaction and maintains strong oversight of CROs in all aspects of study implementation and any study changes.
- Participate in review of all supporting documents for a clinical study – Protocols, Statistical Analysis Plans, CRFs, Data Management Plans, Clinical Study Reports, etc.
- Joint responsibility with clinical lead for monitoring the implementation and progress of a clinical study.
- Develops and maintains relationships with external vendors.
- Collaborates with consultants and contractors to Research and Development.
- Supports the development and implementation of standard operating procedures and common work practices within the team.
- Clinical study team member: works closely with the Study Manager and Clinical Project Manager and is responsible for coordination, tracking, and management of logistics in support of clinical trials.
- Responsible for reconciliation of monthly invoices/PO management. Also responsible for investigator and vendor payments for in-house studies.
- Works closely with Study Manager and legal to review and approve confidentiality agreement, clinical trial agreements and site specific study budgets
- Tracks study status, enrollment, regulatory documentation, and site start‐up status for assigned clinical projects including review and approval of regulatory package for release of clinical supply.
- Reviews clinical trial documentation including monitoring visit reports, monitoring plans, communication plans, timelines, etc.
- Responsible for set‐up, maintenance, reconciliation, and archiving of electronic and paper Trial Master Files along with internal working file.
- Coordinates TMF transfer with CROs.
- Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific study requests and issues.
Skills and Experience
- Requires a BA/BS preferably in nursing, biology, biochemistry, or related areas. Experience in clinical research operations preferred.
- Experience in running one or more clinical studies in the following therapy areas is desirable: anemia, chronic kidney disease, dialysis, and/or oncology.
- Ensures adherence to standard operating procedures, good clinical practice, and FDA regulations with strong understanding of inspection readiness.
- Fluent in Good Clinical Practice (GCP) and is able insure implementation within any clinical study.
- Demonstrated knowledge and experience in the regulatory aspects of pharmaceutical development, including protocol implementation, data collection and reporting, and understands preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA) specifically for FDA and EMA.
- Demonstrated ability to work independently with exceptional organization and attention to detail.
- Excellent oral and written communication and presentation skills.
Interested candidates should apply to firstname.lastname@example.org
About Akebia Therapeutics (www.akebia.com)
We are a biopharmaceutical company focused on the development of novel proprietary therapeutics based on hypoxia inducible factor (HIF) biology and the commercialization of these products for patients with anemia secondary to chronic kidney disease and other indications. Our lead product candidate, AKB-6548, has successfully completed a Phase 2a proof of concept study and is currently completing Phase 2b. Following its IPO in March 2014, the company is preparing for expansion to support global phase 3 programs and commercialization.