Clinical Trial Associate II

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes.

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. The CTA II will:

• With minimal oversight, manage all study start up, maintenance and closeout site management responsibilities, under the supervision of the Clinical Trial Manager
• Lead the maintenance of audit-ready clinical trial documentation and study status: manage 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
• In collaboration with the Sr. CTA/CTM, 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.)
• With minimal oversight, manage clinical operations site payments, prepare site invoices and supporting documentation, and approve site payment distribution
• With minimal oversight, manage drug supply and non-drug supply study trackers
• May assist with reviewing monitoring visit reports

The CTA II will also perform the following CTA responsibilities:

• Support the CTM or project manager with study start up and execution
• Act as a second point of contact between team members, vendors and study sites to assist with study conduct
• Follow established clinical study standards and procedures to plan and conduct clinical research studies
• Request, collect and submit site documents
• Review study start up documents and disseminate to the appropriate functional groups (i.e., legal, regulatory)
• Coordinate IRB/EC submissions and tracking progress to review and approval
• Track study start-up status
• Support the establishment and maintenance of the study TMF. Prepare master Clinical Study Files and Trial Master Files for archiving and/or transfer to a client
• Set-up and maintain study clinical trial management system (CTMS)
• Assist in development of supportive study documents such as informed consent forms, monitoring templates, study subject tracking tools, study drug shipment and monitoring forms, study manuals and training materials, as required for a new clinical study
• Assist with and/or may play a lead role in the development of data collection tools and procedure manuals
• Work with Project Managers/ Clinical Trial Manager to develop status report templates in accordance with client specifications. Assists the Project Managers/ Clinical Trial Manager to compile status report data throughout the course of a study
• Assist with the tracking and compilation of enrollment information from sites
• Participate in tracking and reporting of study data for management reports
• Collate and distribute study related materials
• Collate and assemble study binders (regulatory, pharmacy, laboratory), study reference manuals and study data collection tools
• Support non-drug supply management
• Support clinical operations site payments, prepare site invoices and supporting documentation
• Accompany the CTM or CRA on site monitoring visits, if required
• Will have some site management responsibilities
• Assist with vendor management
• Apply knowledge of company policies and standard practices to resolve problems
• Maintain open communication channels with study sites and members of the study team to ensure proper study progress
• Analyze issues and use judgment to make decisions
• Escalate non-standard problems or issues as may be required
• Contribute to Standard Operating Procedures (SOPs), manuals, forms and templates to support efficient and compliant best practices of the department
• Contribute to thought leadership and knowledge sharing activities
• Lead team trainings
• Continually identify, recommend and implement innovative process ideas and technologies to elevate PROMETRIKA's core competencies and offerings
• Perform other duties as required

EDUCATION

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

EXPERIENCE

• Minimum of 2 years of experience directly supporting clinical research trials

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
• Ability to track many actions and prioritize timely completion
• Cross functional and cross-cultural awareness, someone who seeks out diverse perspectives and considers these perspectives in decisions that are made
• Must possess soft skills and empathy towards others
• Patient centric philosophy towards research is a must
• Familiarity with medical terms
• 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.

The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate's work experience, education/training background and parity with current employees in the same or similar positions.