Clinical Research Associate I/II

Title:  Clinical Research Associate I/II

Reports to:  Senior Director, Clinical Operations

Department: C & R

 

miRagen Therapeutics, Inc. is a clinical stage biopharmaceutical company developing proprietary RNA-targeted therapeutics with a specific focus on microRNAs and their role in diseases where there is a high unmet medical need. Using our expertise in RNA-based therapeutics and systems biology we have created a diverse pipeline of RNA-targeted product candidates.

 

The Clinical Research Associate (CRA) is responsible for supporting clinical studies to meet required quality standards and miRagen Standard Operating Procedures, and to support the delivery of the studies on schedule and on budget. Requires up to 50% travel. The role will include administrative support for clinical studies, including oversight of the trial master file for assigned projects, study monitoring (consistent with experience), and study management support (consistent with experience). The ideal CRA candidate will reflect the experience, skill level, and capacity to monitor and/or support larger and/or more complex studies or programs. Primary responsibilities include:

 

General:

  • Key team member to support all phases of clinical trial (study start-up, patient recruitment, treatment, and close out), with increasing responsibility and independence through levels I, II and III

 

Administrative:

  • Provides administrative tasks as needed to support clinical deliverables
  • Maintains the integrity of clinical Trial Master Files (paper TMF or eTMF), including support for the filing of essential documents for the TMF such as informed consent documents, IRB approvals, financial disclosure forms and other trial related forms for internally managed projects
  • Maintains study communication documentation
  • Compiles study start-up materials or oversight of vendor in developing study start up materials if project is outsourced
  • Assists in the preparation, handling and tracking of site IRB submissions
  • Enters, updates and maintains study and site information in key clinical systems
  • May manage and track inventory of study conduct tools, drug and non-drug clinical supplies with appropriate oversight
  • Facilitates meeting agenda development and takes meeting minutes as appropriate

 

Monitoring:

  • With oversight depending upon experience, capability and seniority, may perform site management and monitoring activities in accordance with federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, trial protocols, and miRagen Standard Operating Procedures (SOPs), monitoring plans, and business processes
  • Conduct site qualification, initiation, interim monitoring, co-monitoring, and study closeout visits as required by study needs and internal project scope, with appropriate mentorship until competency in study visits is established
  • Ensure regulatory and protocol compliance of investigators and sites
  • Ensure quality of data submitted from study sites and assure timely submission of data, including proactive cooperation with data management to identify and resolve data discrepancies
  • Monitor safety and protection of study subjects, including appropriate reporting and follow-up for all safety events by site personnel
  • Review investigator study files and reconcile versus trial master files
  • Ensure investigational product accountability is accurately maintained
  • Ensure that study site personnel have been trained on the protocol, CRFs, study manuals and tools, and applicable regulatory requirements as is appropriate for their level of delegated responsibility
  • Ensure regulatory inspection readiness at assigned clinical sites
  • Report monitoring activities and study site conduct accurately and completely
  • Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner
  • Assist in the training and supervision of field monitors, and Contract Research Organizations
  • With oversight and based on experience, may establish effective relationships with clinical investigators and staff, CROs, and vendors and influence them to meet study objectives
  • Proactively identify and resolve site management issues
  • Travel required: up to 50%

 

Management Support:

  • May support the development of study tools for sites and CRA use such as: Case Report Forms, data review guidelines and edit checks, initial protocol, protocol amendments, and informed consent form, and may assist with Clinical Study Reports (CSRs).  With oversight, may review patient profiles and other study data reports to identify data trends, protocol deviation trends, etc., that require proactive site management
  • May review Clinical Monitoring Reports of other field CRAs
  • Supports feasibility and site selection processes for assigned studies
  • Consistent with capability and experience, may support study management activities such as vendor management, financial management, site payments and tracking, and study management of smaller clinical studies (such as phase 1 healthy volunteer studies)
  • Learns and user of Clinical Systems (e.g. EDC, CTMS, eTMF, etc.)
  • Supports Clinical Trial Managers in updating study plans and ensuring integrity across clinical systems

 

Qualifications

  • BA/BS degree in Health or Life Sciences required, advanced degree preferred
  • A minimum 2 years of relevant experience or demonstration of equivalent capability in a CRA role

 

Required Skills and Abilities

  • Familiarity with GCP
  • Familiarity with management of trial master file content and quality
  • Exceptional communication and interpersonal skills
  • Advanced proficiency in Microsoft Office
  • Reliable, self-motivated, team player
  • Detail oriented with excellent organizational skills

Ability to effectively manage multiple tasks and competing priorities