Senior Clinical Trial Associate - HYBRID in Malvern, PA

Orbis Clinical is seeking a Senior Clinical Trial Associate (hybrid) in Malvern, PA for 6 months.

Responsibilities:

The Senior Clinical Trial Associate (Sr. CTA) supports clinical studies and the Clinical Operations Department in managing various administrative tasks such as the generation of agenda and minutes, maintaining study tracking, filing, supporting clinical lead in quality review responses as well as participating in processing improvement initiatives across the department

• Provide general administrative support to the Clinical Operations Department and assistance to Clinical Operations Trial Leader(s).
• Assist in producing presentations as needed for project, departmental, and/or business development.
• Assists the Clinical Operations Trial Leader(s) with Sponsor oversight, study-specific documentation review and QC, including review of ICF, study plans, study reference manuals, eCRF, etc.
• Assist in coordination and tracking of vendor/third party payments.
• Ensures required study documents are submitted to the CRO-held eTMF.
• Assists the Clinical Operations Trial Leader(s) with Sponsor oversight of CRO-held eTMFs periodic audit and findings resolution..
• Assists with customization of CDA, clinical site contracts & budgets, country insurance and tracking of import/export licenses when applicable.
• Assist the Clinical Operations Trial Leader(s) and clinical team with Investigator Meeting coordination, activities preparation and generating meeting minutes.
• Coordinate document translation, if required.
• May contact clinical sites for specific requests (e.g., enrolment updates, missing documentation, meeting arrangements, etc. when requested).
• Attends internal and external team meetings/teleconferences and generate meeting agenda and minutes when needed.
• Build and maintain Excel trackers using pivot tables to monitor study metrics, regulatory documentation status, and TMF completeness, supporting audit readiness and data integrity
• Other duties may be assigned as required.

Qualifications:

• A minimum of a Bachelor's degree or relevant experience in the industry
• A minimum of 5 plus years of pharmaceutical drug development and clinical operations
• A minimum of 2 plus years of experience in Respiratory Therapeutic Area (COPD, Asthma, EoE preferred). Rare Disease experience would be preferred
• Knowledge of the drug development process, Good Clinical Practices (ICH-GCP), GDP, SOPs and compliance and FDA Code of Federal Regulations is required.
• Strong computer skills in appropriate software applications (Microsoft Office (Excel), email, audio/video conferencing tools) and related clinical systems required.
• Must have strong written and oral communication and organizational skills.
• Must have a flexible mindset with the ability to work in a fast-changing environment.
• Ability to be in the office 3 days a week

Compensation Details:

• Orbis Clinical provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location. 
• The Pay Range for this position is $55.00-$65.00 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). .

EEO and Reasonable Accommodation Statement:

Stone Harbor Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.