We’re looking for a Clinical Research Associate III to join a research-based pharmaceutical company in Gaithersburg, MD. This is an exciting opportunity to help patients affected by rare diseases. Do you want to join a team that is dedicated to developing and delivering life-changing therapies worldwide? If the answer is yes, apply today!
This role is on site in Gaithersburg, MD. Remote work will not be considered.
In this role, you will:
Oversee Monitoring of Clinical Trials.
Train and mentor more junior level Clinical Research Associates, and Clinical Study Specialists.
Contribute to protocol drafting preparation.
Prepare sample informed consent forms (ICFs), case report forms (CRFs), and study support documents (i.e., manuals, training tools, diary cards, source document worksheets) for assigned studies.
Review site generated ICFs for compliance with the study protocol and federal regulations.
Review data management documents (data management plans, coding plans, etc.) for assigned studies.
Review pharmacovigilance plans for assigned studies.
Review statistical analysis plans and data outputs for assigned studies. Independently evaluate and recommend selection of investigators/study sites; participate in identification of potential sites.
Independently train investigators, coordinator, and other trial staff in data collection methods to ensure collection of patient data that is accurate, complete, and conforms to project data standards and protocol requirements.
Ensure the collection, review and updating of all essential documents defined by FDA regulations, company SOPs, and general industry standards.
Track enrollment at both the study and site levels for assigned studies against required projections; identifies and investigates enrollment issues and provide potential solutions to keep.
Develop solutions for logistical and operational issues that arise during trials execution, and communicate these in a timely fashion to investigators, coordinator and company staff.
Understand and apply clinical scientific research and knowledge of the drug development process, including significance of and differences between Phase I-IV clinical trial design, in all CRA activities.
Assist with the selection, oversight, and management of vendor functions. Working closely with CSM to manage study deliverables, timeline and overall study budget.
Review clinical research literature as needed.
Act as point of contact for day to day study operations for monitoring team.
Skills and Qualifications:
R.N. or Bachelor's degree in biological sciences or other healthcare-related field.
5+ years of pharmaceutical, clinical or bioresearch experience.
3+ years of experience Clinical Research Associate.
Exposure to multiple therapeutic areas preferred.
Self-starter with the ability to work independently and in a team environment. Excellent written and verbal communication skills.
Detail-oriented, organized, and the ability to multi-task and meet deadlines.
Ability to travel up to 25-30% of the time.
Experience in drafting and reviewing monitoring plans.
Experience in site monitoring and some CRA team management.
Ability to adapt to changes in the work environment.