Clinical Trial Associate II

Prometrika LLC•Cambridge, MA

About The Position

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.

Requirements

Bachelor’s degree in a scientific or health related field or equivalent
Minimum of 2 years of experience directly supporting clinical research trials
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
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.

Nice To Haves

PMP Certification preferred but not required

Responsibilities

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
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