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Clinical Trial Associate
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What they do
A Clinical Research Associate is responsible for running clinical trials, usually for an organization undertaking pharmacological drug testing. Will ensure that trials adhere to good clinical practice guidelines for monitoring clinical trials.
$107,103 / year median in Pennsylvania
-3% projected decline
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Clinical Trial Associate
Wayne, PA
Posted yesterday
Apply Now Must be Local and Willing to be on site in Wayne, PA Job Responsibilities Create and/or review study plans, specification documents, materials, and tools. Support outsourced activities to Clinical Research Organizations (CROs) and other third-party vendors for assigned activities. Responsible for tracking study progress in CTMS, including site activation, patient enrollment, patient status, oversight of Regulatory documents for site initiation and close out. Deliver and execute operational tasks, and assist in tracking study metrics, maintenance, and distribution of study trackers. Collaborate with clinical trial sites to develop relationships and support the collection of relevant study materials and documentation. Review documents for completeness, accuracy, and compliance with protocol and appropriate regulations; Identify issues and take appropriate corrective actions. Assist in preparing or review study-related documents (i.e., ICF, clinical trial tools, templates, training materials, manuals, study newsletters, etc.). Support project meeting logistics such as: calendar management, room and equipment set up, collation of materials, and attendance tracking. Working with the Clinical Trial Manager, prepare meeting agendas and draft, finalize, and distribute meeting minutes. QC oversight of CRO, TMF, Monitoring Visit Reports, Payments, Safety Alert acknowledgments, ICFs, protocol amendments, and study close out. Build strong professional relationships with vendors, and individuals at all cross functional levels of the organization. Track payments to vendors and study sites as appropriate. Oversee TMF Quality Review for study team; complete TMF QC for the department quarterly for each study, including collecting, reviewing, and submitting documents to the TMF. Education & Experience Bachelor's degree in life sciences or healthcare-related field. Minimum of 2-5 years of experience in a relevant field, e.g., clinical site, CRO, Sponsor or clinical trial vendor (sponsor experience preferred). Working knowledge of ICH GCP regulations and clinical protocols. Strong computer skills, including Smartsheet, Excel, Word, PowerPoint, SharePoint, Veeva, and Outlook. Sound analytical and problem-solving skills; ability to act with a sense of urgency. Demonstrated effectiveness in resolving complex site management issues. Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines. Ability to work in a fast-paced environment with demonstrated agility to juggle multiple competing tasks and demands. Excellent written and verbal communication skills. Team player that takes initiative and is willing to support optimizing the way we work. Job Type & Location This is a Contract position based out of Wayne, PA. Pay and Benefits The pay range for this position is $43.00 - $47.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Wayne,PA.