Clinical Trial Associate II

About the role

The Clinical Trial Associate II (CTA II) supports, coordinates, and implements clinical research projects, working with the study team in the initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and SOPs/WPDs.

Responsibilities

• Manage all study start up, maintenance and closeout site management responsibilities, under the supervision of the Clinical Trial Manager
• Maintain and track regulatory documentation, IND Safety Letter distribution, Confidentiality Agreements and Clinical Trial Contracts, as well as other clinical trial documents
• Set-up, implement and maintain the audit-ready eTMF system under guidance of the Clinical Trial Manager
• Develop study specific processes to ensure that necessary study supplies are available at sites as required, coordinating with appropriate vendors as needed (i.e., Case Report Forms, Study Manuals, lab kits, drug supplies, lab supplies, etc.)
• Manage clinical operations site payments, prepare site invoices and supporting documentation, and approve site payment distribution
• Manage drug supply and non-drug supply study trackers
• Assist with reviewing monitoring visit reports

Qualifications

• Education: Bachelor’s degree in a scientific or health related field or equivalent
• PMP Certification preferred but not required

Skills

• Problem solving abilities, troubleshooting abilities and resourcefulness
• Analytical problem-solving experience, including excellent organizational skills and attention to detail
• Working knowledge of clinical drug development process as well as ICH, GCP guidelines, and US FDA regulations
• Effective communication and interpersonal skills; ability to build relationships internally and externally
• Knowledge seeking personality, interested in continually seeking out new information, techniques and diverse perspectives
• Cross functional and cross-cultural awareness, someone who seeks out diverse perspectives and considers these perspectives in decisions that are made
• Soft skills and empathy towards others
• Patient centric philosophy towards research is a must
• Demonstrated writing skills to deliver messages effectively so messages are clearly understood
• Demonstrated expertise with PCs and standard Microsoft Office software applications

Physical Requirements

Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.