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Clinical Operations Professional - CRA II

Clinical Operations Professional - CRA II

ID 
2017-1067
Category 
Clinical Operations
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

 

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

**This is an in-house CRA position in Rockville, MD, and requires clinical trial management and oversight experience. Relocation assistance may be available**

 

The Clinical Research Associate II (CRA II) acts as a delegate of the Clinical Project Manager in the operational set-up, delivery and close out of clinical trials.  The CRA II will take responsibility for routine operational study activities; this may include such things as coordination of site startup, day to day management of clinical sites and participating in the development of particular key study documents or plans.

 

Responsibilities and Job Duties

 

  • Clinical Trial Planning - Provides support to the Clinical Project Manager on clinical trials that include, but are not limited to: clinical planning tools, feasibility, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, Investigator selection, systems (e.g., CTMS, IXRS etc.), clinical trial related operational manuals, training materials, and various clinical trial plans (e.g., monitoring, risk mitigation, communication plans, etc.) site selection and budget planning.  Responsible for tracking and providing reports on the clinical trial activities.
  • Monitoring Activities – Assists on clinical monitoring activities and the overall site activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics.  Assists the Clinical Project Manager on clinical monitoring (site qualification, site initiation, interim monitoring, clinical trial closeout visits) to ensure integrity, accuracy and accountability of clinical data. Informs Clinical Project Manager and other leadership (as appropriate) on overall clinical trial status and of potential issues/mitigation.  May participate in site visits as needed.
  • Site Management – Establishes and maintains regular contact with clinical trial sites to ensure operational activities are progressing according to plans. Coordinates and tracks study, country and site start-up activities in regard to regulatory documents, contracts and budgets.  Coordinates and tracks activities in regard to management of patient recruitment.  Assists in the set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate country/site insurance.  Assists in the development of study training materials. Assists in the investigator payment process and handles invoices related to projects assigned. Escalates study and team issues to Clinical Project Manager.
  • Vendor Interaction – Establishes and maintains regular contact with vendors to ensure operational activities are progressing according to plans.  Ensures that vendors comply with all required standards and raises any issues and/or concerns.  Assists with invoice management throughout the trial life cycle 
  • Internal/External Meetings – Responsible for attending and preparing meeting minutes for internal team meetings, investigator meetings, and other trial- specific meetings as required.      
  • Data Listing Review – Assists with the in-house review of clinical data listings (protocol deviations, focused study data review, etc.) for completeness and accuracy and escalate issues as needed. 
  • Trial Master File -  Ensures study regulatory files are collected and inventoried and filed as per MacroGenics requirements
  • Ancillary Supplies – Ensures study materials and supplies are available in a timely manner at the location here needed.
  • Study Management Tools - Responsible for the maintenance and updating of data as appropriate in project management tools including CTMS.  Maintains project processes and tracking systems (i.e. Screening and Randomization status) and reports to management.

 

Qualifications

Education

BA/BS or equivalent degree in a scientific discipline or related healthcare field

 

Experience

Minimum of two years as a CRA or in Clinical Study Management in a pharmaceutical, biotechnology company or clinical research organization(CRO)

 

Knowledge, Skills and Abilities

  • Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines
  • Ability to multi-task with minimal supervision
  • Solid attention to detail and excellent organization skills
  • Solid interpersonal skills and communication skills (both written and oral)
  • Ability to establish priorities with a sense of urgency
  • Knowledge of clinical trial conduct, EDC systems and IVRS
  • Ability to travel to meetings, sites and vendors approximately 10-20%     

 

Preferred Qualifications

Experience in oncology preferred

 

Supervisory Responsibilities

None

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.