Job Description
Target Pay Rate: 75-90/hr **salary will be commensurate with experience
Position Description:
The clinical trials associated with client development programs will be performed on a global scale in coordination with internal team members and external vendors. These studies will be submitted to health care regulatory authorities around the world such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). We are seeking a Consultant Clinical Research Associate (CRA) responsible for site management, clinical study monitoring (onsite and remote), and some lead CRA support, for assigned studies according to FDA regulations, Good Clinical Practice (GCP), International Conference on Harmonization (ICH) and relevant Standard Operating Procedures (SOPs).
Essential Duties & Responsibilities The CRA will be expected to perform the following, but is not limited to:
- Perform clinical study monitoring visits including evaluation, initiation, interim monitoring and close-out and document observations in trip reports and follow-up letters as per SOPs and applicable guidelines. Up to 65% travel to clinical trial sites may be required.
- Maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, previously identified issues are being resolved and the data is being recorded in a timely manner
- Conduct remote review of data entered on electronic Case Report Forms (eCRFs)
- Provide clinical study progress updates for assigned sites to the CTM as required
- Assist CTM with development and review clinical study documents and tools (e.g., model informed consent forms, site study aids and investigator site file binders)
- Support sites in development of site-specific informed consent forms, IRB/IEC submission materials, responses to IRB/IEC requests for clarifications and obtaining IRB/IEC approval
- In collaboration with CTM and study team, ensure all required essential regulatory documents and approvals are in place prior to investigational product (IP) shipment
- Provide applicable updates for site related documentation for filing in the electronic Trial Master File (eTMF) and the Investigator Site File (ISF) in the TMF
- Maintain study tracking tools as applicable in Clinical Trial Management System (CTMS) (e.g., site lists, enrollment tracking)
- Escalate observed deficiencies and issues to CTM expeditiously, present potential solutions and follow all issues through to resolution
- Assist CTM with preparation of meeting materials for study training, investigational sites and vendors and participate as needed.
- Support the CTM as a lead CRA, responsible for monitoring report review and other tasks as agreed upon by the CTM
- Other project work as assigned
Core Competencies, Knowledge and Skill Requirements - Excellent verbal and written communication skills
- Daily demonstration of a positive, ‘can do’ and service-oriented attitude; detail-oriented with a commitment to accuracy
- Ability to multi-task and shift priorities quickly while working under tight deadlines
- Proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
- Able to travel up to 70% as required by business needs
REQUIREMENTS Education: Bachelor of Science in a closely relevant field
Professional / Therapeutic Experience - Clinical research professional with 4+ years of independent monitoring experience in Phase II and III trials in a pharmaceutical or CRO setting
- Rare disease or complex study experience
- Transplant and/or immunology experience preferred, but not required
Job Tags
Contract work, Interim role, Remote work, Shift work,