Midwest/East Coast Clinical Research Associate
Chicago, IL Chicago, IL 60601 US
Job Description
Position Description:
We are seeking a Consultant Clinical Research Associate (CRA) located in the US Midwest or East region who will be responsible for site management, clinical study monitoring (onsite and remote), and some lead CRA support, for assigned investigative sites in accordance with FDA regulations, Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and relevant Standard Operating Procedures (SOPs).
Client is a fast-moving, small-to-medium company with a sense of urgency around what we do. A successful candidate will manage ambiguity and uncertainty successfully within a dynamic environment.
ESSENTIAL DUTIES & RESPONSIBILITIES
The CRA will be expected to perform the following responsibilities, including but not limited to:
- Perform clinical study monitoring visits including evaluation, initiation, interim monitoring and close-out visits and document observations in monitoring visit reports and follow-up letters as per Standard Operating Procedures (SOPs), the Clinical Monitoring Plan (CMP), and guidelines.
- Conduct remote review of data entered in eCRFs between monitoring visits as per the CMP.
- Maintain regular contact with assigned investigative sites between monitoring visits to confirm that the protocol is being followed, previously identified issues are being resolved, and the data is being recorded in the electronic Case Report Forms (eCRFs) within the expected timeframe noted in the Clinical Trial Agreement (CTA).
- Provide clinical study progress updates for assigned sites to the Clinical Trial Manager (CTM) as required.
- Escalate observed deficiencies and issues to the CTM expeditiously per client SOPs and guidelines, present potential solutions, and follow all issues through to resolution.
- Support assigned investigative sites with the development of site-specific informed consent form(s) (ICFs), IRB submission materials, responses to IRB/IEC requests for clarifications, and obtaining IRB approval.
- In collaboration with CTM and clinical study team, ensure all required essential regulatory documents and approvals are in place prior to investigational product (IP) shipment.
- Provide applicable updates for investigative site related documentation for filing in the electronic Trial Master File (eTMF) and the Investigator Site File (ISF).
- Maintain study tracking tools as applicable in the Clinical Trial Management System (CTMS) (e.g., site lists, subject and enrollment tracking, action items, protocol deviations, etc.).
- When requested, assist CTM with the following responsibilities, including but not limited to the review and approval of monitoring visit reports per client SOPs and processes, Development and review clinical study documents and tools (e.g., Model Informed Consent Forms, Study Plans, study aids for investigative sites), and preparation of meeting presentation/materials for study training provided to investigational sites and vendors.
- Attend regular/reoccurring clinical study team meetings (e.g., weekly), Cross Function Study Team (CFST) meetings (e.g., bi-weekly, monthly), and Study Teleconferences with investigative sites (e.g., monthly).
- Other project work as assigned by the CTM or Clinical Operations Director (COD).
REQUIREMENTS
Core Competencies, Knowledge / Skills, and Travel
- Strong understanding of ICH, GCP, FDA, and other regulatory guidelines and maintain current ICH GCP certification
- 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, Teams, SharePoint, and PowerPoint)
- Proficiency in clinical trial systems (e.g., CTMS, EDC, eTMF, EMR, IRT/IXRS, etc.)
- Able to travel up to 70% as required by business needs
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company
- Dynamic and innovative skills with a well-developed sense of teamwork
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
Minimum of a Bachelor of Science, or equivalent, degree in a closely relevant field
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