CRA Lead (Clinical Research Associate)
About the Job:
In accordance with ICH GCP guidelines and Wellstat SOPs, the In-house Clinical Research Associate (CRA) will: The In-house CRA will have single accountability for a set of clinical operations and/or data management activities for 1 or more clinical trials at Wellstat Therapeutics and potentially full responsibility for 1 or more smaller clinical trials. CRA should possess strong communication and clinical project management skills, be highly competent in Microsoft Office Suite (including MS Word, Excel, and PowerPoint), and have past experience managing clinical trial activities in a fast-paced environment within a biotech/pharmaceutical company.
Responsibilities:
Manage and have single accountability for a set of clinical operations and/or data management activities for studies including but not limited to:
- CRF creation and clinical database setup/management/cleanup/closure
- Site selection and start up activities
- Clinical monitoring activities
- Clinical document authoring including informed consent forms, protocols, investigator brochures, etc.
Additional responsibilities include:
- Act as the primary contact person for the clinical sites and vendors
- Lead feasibility activities as needed
- Assist with outsourcing services to vendors including preparation of request for proposals, analytical review and feedback on vendor proposals and statements of work and direct input into the recruitment and selection of vendors
- Manage clinical site contracts and payments
- Responsible for monitoring and tracking clinical drug supplies at the study sites
- Responsible for evaluating clinical site and vendor performance
- Assist with regulatory IND/NDA submissions as needed Participate in clinical audits, lead the effort to track and collect missing or outdated documents or follow up on outcome of clinical audits
- Ensure understanding of appropriate Wellstat SOPs, ICH-GCP guidelines
- Ensure studies and clinical/data management deliverables are performed with quality standards and in accordance with ICH/GCP and other regulatory requirements
- Additional duties as assigned by Director, Clinical Projects or VP R&D
Qualifications and Education Requirements:
- Strong understanding of the clinical trials process and regulatory requirements
- Proven track record of successfully managing clinical trial activities in a quality manner and within the projected timeline and budget Oncology and Metabolic Therapeutic Area a plus
- Able to lead and work within teams and networks with internal and external team members promoting collaboration, effective work procedures and effective communication among the team
- Demonstrate conceptual, analytical and strategic thinking
- Demonstrate effective problem solving
- Able to understand the impact of technology on studies and to use and develop computer skills
- Current GCP training
- Knowledge of medical terminology
- Previous site monitoring experience and in-house CRA/project management assistance within a pharm/biotech company preferred
- Expert in MS Word, Excel, and PowerPoint required, MS Project experience a plus
- Possess excellent English language written and verbal communication skills
- Strong organizing and planning skills to work independently with efficiency and accuracy
- Ability to travel up to 15%
Wellstat Therapeutics Corporation is an equal opportunity employer and offers a competitive salary and comprehensive benefits package. Please send CV and salary requirements to: Wellstat Therapeutics Corporation, 930 Clopper Road, Gaithersburg, MD 20878, Attn: HR/JV or E-Fax to 301-519-7005 or apply online at .
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