Senior Clinical Trial Associate
Job
Actalent
Remote
$98,800 Salary, Full-Time
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Job Description
Job Title:
Senior Clinical Trial Associate Job Description The Senior Clinical Trial Associate (Sr. CTA) plays a crucial role in supporting clinical studies and the Clinical Operations Department. This position involves managing various administrative tasks such as generating agendas and minutes, maintaining study tracking, filing, and supporting clinical leads in quality review responses. Additionally, the Sr. CTA will participate in process improvement initiatives across the department, providing general administrative support and assistance to Clinical Operations Trial Leaders. Responsibilities Provide general administrative support to the Clinical Operations Department and assistance to Clinical Operations Trial Leaders. Assist in producing presentations for projects, departmental, and business development needs. Support Clinical Operations Trial Leaders with sponsor oversight, study-specific documentation review, and quality control. Coordinate and track vendor/third-party payments. Ensure the submission of required study documents to the CRO-held electronic Trial Master File (eTMF). Assist with oversight of periodic audits and resolution of findings related to CRO-held eTMFs. Customize clinical site contracts and budgets, and track import/export licenses when applicable. Coordinate Investigator Meeting activities and generate meeting minutes. Coordinate document translation, if required. Contact clinical sites for specific requests, such as enrollment updates and missing documentation. Attend internal and external meetings/teleconferences, generate meeting agendas and minutes, and maintain Excel trackers to monitor study metrics and regulatory documentation status. Essential Skills Proven experience in independently supporting global clinical trials. Hands-on experience supporting global trials, preferably in APAC and Europe. Strong understanding of country-specific regulatory requirements. Experience managing third-party payments, clinical trial insurance, and CDAs/contract documentation. Comfortable working across different regulatory frameworks simultaneously. Direct interaction with investigative sites and strong site coordination skills. Ability to work with minimal supervision and escalate appropriately. Experience in respiratory indications and rare diseases is preferred. Comfortable working within a matrixed team environment and collaborating cross-functionally. Additional Skills & Qualifications Bachelor's degree or relevant industry experience. Minimum of 5 years in pharmaceutical drug development and clinical operations. Minimum of 2 years of experience in the Respiratory Therapeutic Area (COPD, Asthma, EoE preferred). Knowledge of drug development processes, Good Clinical Practices (ICH-GCP), GDP, SOPs, and FDA Code of Federal Regulations. Strong computer skills in Microsoft Office (Excel) and related clinical systems. Strong written and oral communication and organizational skills. Flexible mindset with the ability to work in a fast-changing environment. Work Environment The position requires the ability to be in the office 3 days a week, with locations in Malvern, PA, and San Diego, CA. The work environment is dynamic, with opportunities to take on responsibilities and support the growing clinical team. The company offers a supportive management team with a clear vision for growth, creating a positive environment for career development. Job Type & Location This is a Contract position based out of Malvern, PA. Pay and Benefits The pay range for this position is $45.00 - $50.00/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 Malvern,PA.
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