In-house CRA

San Diego, CA

Contract To Perm

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as in In-House CRA. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity. 

RESPONSIBILITIES

  • Conduct pre-study, initiation, routine monitoring and closeout visits of study sites (as required)
  • Co-monitoring and oversight of CRO or contract CRAs for pre-study, initiation, routine monitoring and closeout visits
  • Perform all aspects of study site management both whilst on-site and remote site management
  • Verify compliance and quality of collected data
  • Verify the receipt, handling, accounting, storage conditions, and availability of clinical products and supplies
  • Verify study data and facilitate the resolution of data queries and requests from Data Management
  • Conduct and coordinate all activities including report writing associated with initiation, interim monitoring, study close out and audit visits as assigned
  • Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations
  • Support TMF set-up, ongoing quality review, and final reconciliation of study documents
  • Participate in study specific tasks such as Investigator identification, recruitment, collection of Investigator regulatory documents and site activation
  • Contribute to and/or develop the Monitoring Plan and ensure appropriate quality and timely monitoring of clinical sites
  • Assist in development of study materials, case report forms (CRFs), informed consent documents for clinical studies, as needed
  • Prepare or provide input into status reports and act as primary contact for field CRAs regarding project activity
  • Ensure management of Trial Master File
  • Keep the Clinical Operations lead informed of the progress of projects for which designated responsibility
  • Development and maintaining of good working relationship with investigators and study staff
  • Assist in the organization and participate in investigators’ meetings (as applicable)
  • Perform protocol specifics as well as GCP training for site personnel

EXPERIENCE 

  • Minimum two years of CRA experience; oncology preferred
  • Proven clinical monitoring skills
  • Demonstrated understanding of medical terminology
  • Demonstrated ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures
  • Customer focus
  • Good organizational and time management skills
  • Effective interpersonal skills
  • Attention to detail
  • Proven flexibility and adaptability
  • Ability to work in a team or independently as required
  • Good English language and grammar skills
  • Good presentation skills
  • Computer skills required-must be proficient in Word, Excel, and PowerPoint
  • Excellent communication skills, ability to communicate effectively with all levels at the clinical sites and good people skills critical
  • Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential
  • Flexibility; ability to travel up to 50-60%+

EDUCATION

  • BA/BS or RN degree required

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.


Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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