ProPharma Group

Senior Clinical Research Associate

ProPharma Group • $80K — $110K *
Western Springs, IL 60558In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree or equivalent experience in a relevant field.
  • Over 5 years of experience as a Clinical Research Associate.
  • Strong understanding of applicable local laws, regulatory requirements, ICH Guidelines, and GCPs.
  • Proficiency in electronic data capture systems (EDC), CTMS, IVRS, and eTMF.
  • Excellent verbal and written communication skills with effective presentation abilities.
  • Strong organizational skills with attention to detail and ability to prioritize tasks.
  • Experience using Microsoft Office Suite to create reports and presentations.

Responsibilities

  • Conduct monitoring and co-monitoring visits for assigned clinical sites both in-person and remotely.
  • Perform study start-up activities in compliance with local practices for sites outside the US.
  • Develop site-specific monitoring documentation including trackers and clinical monitoring plans.
  • Review source documents and case report forms for data accuracy and integrity.
  • Manage and track investigational supplies including inventory and reconciliation.
  • Monitor trial protocol compliance and report updates on site activities and protocol deviations.
  • Communicate effectively with clinical sites and project teams to address study needs.

Benefits

  • Supports remote work with options for hybrid collaboration at office locations.
  • Emphasis on professional development and training focused on project goals.
Full Job Description
  • 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.


  • Ex-US: May be responsible for performing study start up activities in accordance with local practice, including site identification and feasibility activities, collection and preparation of site essential documents, Ethics Committee submissions, and other site set up activities.


  • Support 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.


  • Review source document and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues.


  • Manage, prepare, send, track, and return investigational supplies as assigned. Includes monitoring and documenting investigational supplies dispensing, inventory, and reconciliation.


  • Monitor 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.


  • Review and oversee regulatory documentations for accuracy and completeness and support assigned clinical sites with any regulatory concerns as appropriate.


  • Communicate 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.


  • Participate 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.


Necessary Skills and Abilities:

  • 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 local law, local regulatory requirements and 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.


Educational Requirements:

  • Bachelor's degree or equivalent combination of education and experience.


Experience Requirements:

  • > 5 years of experience as a Clinical Research Associate.


#LI-JH1#LI-REMOTE

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

About ProPharma Group

ProPharma Group is a pharmaceutical consulting company that provides regulatory compliance, pharmacovigilance, and medical information services to clients in the healthcare industry. The company was founded in 2001 and is headquartered in Shawnee Mission, Kansas. ProPharma Group offers a range of services, including clinical trial support, quality assurance, and validation services. The company has worked with clients in a variety of industries, including pharmaceuticals, biotechnology, and medical devices.
Learn more about ProPharma Group
Size
500 employees
Industry
Pharmaceuticals & Biotech
Net Income
$5 million
Founded
2001
5 Year Trend
+30%
Revenue
$50 million
* Ladders Estimates

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