ProPharma · 3 months ago
Clinical Research Associate (West Coast)
Chicago
Full-time
Hybrid
Mid Level
4+ years expProPharma is a leading consulting firm that has been enhancing patient health and wellness for over 20 years through its expertise in biotech, med device, and pharmaceutical sectors. The Clinical Research Associate position involves clinical monitoring for assigned protocols and investigational sites, ensuring compliance with study protocols and regulatory requirements.
BiopharmaMedicalPharmaceutical
Responsibilities
Responsible for conduct of all types of monitoring, and co-monitoring visits and associated monitoring activities for assigned clinical sites both in person, and remote. This includes evaluation, site initiation, interim and close out monitoring visits. Responsible for monitoring report writing and completion within required SOP and local regulatory parameters
Supports development of study specific documentation related to monitoring activities as assigned. This includes but is not limited to monitoring trackers, clinical monitoring guidelines, clinical monitoring plan, source document templates, site tools, and worksheets, etc. Responsible for site personnel management and training on the protocol requirements, proper source documentation procedures compliance, and case report completion requirements
Responsible for source document and case report forms review for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues
Managing, preparing, sending, tracking, and returning investigational supplies as assigned. Includes monitoring and documenting investigational supplies dispensing, inventory, and reconciliation
Monitoring assigned clinical trials and clinical sites by reviewing and reporting site enrollment, and termination updates, monitoring visits, protocol deviations, serious adverse events, laboratory abnormalities and any other activity at the site that contributes to proper conduct of the clinical trial per protocol, and regulatory requirements
Responsible for review and oversight of regulatory documentations for accuracy, completeness, and supporting assigned clinical sites with any regulatory concerns as appropriate
Responsible for consistent and timely communication with assigned clinical sites, investigators, site personnel, client personnel, and any other cross functional team member involved in the assigned clinical trials to address any study needs related to the monitoring and site management activities as assigned
Participates in meetings and conference calls with internal project teams, Sponsor teams, and any external partners working on execution of the assigned clinical trial
Other duties as assigned
Qualification
Required
Bachelor's degree or equivalent combination of education and experience
4 years of experience as a Clinical Research Associate
Excellent verbal, written communication skills and interpersonal and presentation skills are required
Excellent computer skills with experience using Microsoft Office (Outlook, Word, Excel, and Power Point) applications to prepare charts, tables, forms, reports, and presentations required
Electronic data capture (EDC), CTMS, IVRS, and eTMF experience required
Knowledge of applicable regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
Must be able to prioritize tasks, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision
Must be able to offer solutions when obstacles are identified and train as necessary to achieve project goals
Must have a general understanding of routine project goals from an organizational perspective
Strong organizational skills and attention to details required. Ability to prioritize and plan workload is essential
Preferred
Targeting those on the west coast with IVD therapeutic experience
Company
ProPharma
At ProPharma, we help pharmaceutical, biotechnology, and medical device companies bring life-changing therapies to market.
1001-5000 employees
H1B Sponsorship
ProPharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (4)
2023 (6)
2022 (4)
Funding
Current Stage
Late StageTotal Funding
$8.63MKey Investors
Jump Capital
2020-10-23Series Unknown· $8.63M
2020-09-22Acquired
2015-03-25Series Unknown
Leadership Team
Dawn Sherman
CEO and Board Chair
Brian Tuttle
Chief Financial Officer
Recent News
2025-12-11
2025-12-05
Company data provided by crunchbase