Clinical Research Associate - Los Angeles/San Diego, CA

OBJECTIVE: 

Manage activities of clinical investigative sites as they relate to Takeda clinical studies to ensure successful execution of the protocol.  This position functions in an independent and regionally-based capacity.

 

ACCOUNTABILITIES:  Responsible for site qualification, initiation, interim monitoring and study close-out visits for Phase 1-4 studies in accordance with country-specific regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Takeda Standard Operating Procedures (SOPs) and business processes.  Identify, evaluate and recommend new/potential investigators/sites on an on-going basis.  Potential sites may be identified through networking or internal TGRD requests to assist in the placement of planned clinical studies with qualified investigators.Expedite pre-study processes and Site Initiation Visits (SIVs). Conduct SIVs and training of study site personnel regarding the protocol and applicable regulatory requirements in collaboration with pertinent project team members. Conduct all clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to:  Manage multiple protocols across multiple therapeutic areas, which may require travel  based upon assigned site location and/or geographic territory Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnelEnsure safety and protection of study subjects according to the monitoring plan, TGRD SOPs, ICH Guidelines, and country-specific regulations.Manage overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives Anticipate and proactively solve study-related clinical site issues as they occur. Initiate, recommend and communicate corrective action as indicated. Use functional expertise and exercise good judgment in seeking appropriate guidance.  Ensure that follow-up to any and all corrective action taken at the clinical site is properly documented.Appropriately escalate serious or outstanding issues to Lead CRA/RM or the appropriate project team member(s)Facilitate Quality Assurance Audit processes as indicated Ensure regulatory inspection readiness at assigned clinical sitesInteracts and builds professional and collaborative relationships with all study personnel (investigator, study coordinator, pharmacist), peers and office-based personnel.  Uses multiple technologies to maintain open and frequent communication with TGRD personnel.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. Exhibit high degree of flexibility when facing changes, such as protocol modifications, program priorities, enrollment challenges, etc.Participate in departmental meetingsEmploy good fiscal management to conserve costs of departmental operation and controls travel expenses, with guidance from Lead CRA/RMIdentify and partner with other Takeda personnel to develop innovative processes and technologies to increase the quality, productivity, and efficiency of Site Operations and conserve overall departmental operating costs.Maintain knowledge and expertise across multi-therapeutic areas through clinical and scientific literature review, ongoing awareness of industry practices and participation in professional activities.Create a positive work environment by encouraging mutual respect, innovation, and accountability at all levels.Perform other tasks as requested by management. 



EDUCATION, EXPERIENCE AND SKILLS: 

Education:Bachelor’s Degree required; medical/science/nursing background is preferred.  MS, MA, MBA, MPH desired.

Experience:Three (3-5) years of clinical related experience, of which 2-3 years must be in clinical research monitoring  Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials  Advanced and thorough knowledge related to ICH/GCP Guidelines and/or country-specific regulations, and applicable local regulationsExperience in on-site monitoring of investigational drug trials is required

Skills:Demonstrated strong site management and monitoring skillsExhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.Effective and proactive communication skills are requiredAttention to detail, strong interpersonal skills, excellent verbal and written communication skillsAcute observational skills, analytical and conceptual capabilitiesCompetence in the use of personal computers, including experience with word processing, spread sheets, email and web-browser applications. Previous experience with electronic data capture systems desirableStrong ability to work independently with minimal supervision.

LICENSES/CERTIFICATIONS:ACRP-CRA certification highly desired



TRAVEL REQUIREMENTS:Requires up to 70% travel.

ADDITIONAL INFORMATION:The actual number of days on site will vary according to current project demands. It is expected that at least one day per week will be spent in the home office for activities such as but not limited to: site visit and administrative report completion, preparing for and following up on site monitoring and project related activities.

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