Lead Clinical Research Associate (CRA)
Lead Clinical Research Associate (CRA)
Experienced
Corporate Office - Austin, TX
Full Time
4 Year Degree
Up to 50%
Biotech
Description

Company Summary: Aeglea is a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer. Aeglea is developing pegzilarginase, its lead investigational therapy, for the treatment of Arginase 1 Deficiency, as monotherapy in arginine-dependent cancers and in combination with an immune checkpoint inhibitor for small cell lung cancer. In addition, Aeglea has an active research pipeline of other human enzyme-based approaches in both therapeutic areas. 

 

Position Summary: Aeglea BioTherapeutics based in Austin Texas, is actively recruiting for a Lead Clinical Research Associate. This position will responsible for overseeing team of Clinical Research Associates (CRA) who provide qualification, selection, monitoring, and close out of sites performing clinical trial(s) as well as monitor's sites on behalf of Aeglea Biotherapeutics. Reviews work load requirements and provides resourcing for all clinical field activities. Ensures that CRA staff perform their duties in line with the Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonisation - Good Clinical Practice (ICH-GCP).

 

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following:

  • Assist Evaluate and plan for clinical trial resourcing requirements for qualification, training, monitoring and support of sites during the conduct of the trials.
  • Develop a monitoring plan for each clinical trial.
  • Hire, train and serve as line manager for monitors (CRAs). Ensure the monitors are adequately trained on the therapeutic area, their assigned study(ies), SOPs and GCPs and are prepared to train the site staff during the Site Initiation Visit (SIV) and at other times to trial-specific industry standards.
  • Liaise with doctors/consultants or investigators conducting the trial as required to ensure that monitors are meeting expectations.
  • Oversee the setup of the trial sites; ensuring each site has the appropriate trial materials to conduct the study.
  • Oversee site activation and monitoring process for each study.
  • Develop and monitor metrics to evaluate the monitor and site performance. In the event of performance concerns, evaluate cause and mitigate risk to study.
  • Regularly review CRF data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring.
  • Track patient enrollment and recommend solutions to monitoring staff to increase appropriate enrollment of qualified subjects.
  • Provide support for the processing of data queries and ensure through the monitoring team that queries are addressed in a timely manner.
  • Review and approve monitoring visit reports. Track monitoring/site issues and assure their timely resolution.
  • Develop and execute a plan to close trial sites on completion of the trial and perform associated close­ out activities.
  • Ensure adherence to GCP, Standard Operating Procedures (SOPs) and study protocols.
  • Ensure monitors are providing for regulatory compliance of investigational sites with Aeglea Biotherapeutics SOPs, FDA regulations, and ICH guidelines.
  • Coordinate data management activities.
  • Co-monitor as required to provide coaching and manage performance of CRAs.
  • May assist with creation or review of consent forms and other site related materials.
  • May prepare study documents such as the Monitoring Plan, Study Operations Manual, Source Data Verification Plan, Laboratory Manual, Pharmacy Manual, Informed Consents, etc.
  • Assist with protocol development and study report completion as requested.
  • Assist with CRF development as requested.
  • Assist with planning and participate in investigator meetings.
  • May be responsible for onsite monitoring of one or more sites.
  • Other duties as assigned.
Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.

 

Education/Experience: The ideal candidate will offer:

  • Bachelor's degree (BA/BS) or nursing degree (associate of applied science or above). Clinical research or life science degree preferred. Advanced degree is preferred.
  • Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred.
  • Seven or more years of relevant experience required with at least two years of experience in a pharmaceutical/biotech company preferred.
  • Prior supervisory or study management experience strongly preferred.

 

Knowledge, Skills and Abilities:

  • Demonstrated in depth knowledge of GCP, ICH guidelines, and FDA regulations.
  • Demonstrated ability to work independently and in a team environment.
  • Proficiency with MS Office.
  • Excellent oral and written communication skills and strong organizational abilities.
  • Ability and willingness to travel 25% - 50% of the time (internationally and domestically).

 

Work Environment:

This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Light physical activity performing non-strenuous daily activities of an administrative nature. Including but not limited to: Sitting for greater than 75% of your time, standing and walking for up to 25% of your time. Manual dexterity sufficient to reach/handle items and work with the fingers. Use of hands to fingers for typing and other computer activity for up to 75% of your time. Reaching with hands and arms, climb or balance, stoop, kneel, crouch, or crawl less than 25% of your time. Ability to lift, up to 25lbs, less than 25% of the time.

 

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.

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