21 days old

Temporary Senior Clinical Research Associate

ACADIA Pharmaceuticals
San Diego, CA 92101
  • Job Code
    114795963
ACADIA Pharmaceuticals

ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity

Position Summary:

The Senior Clinical Research Associate (in-house) will review/monitor, and track, and manage all study related tasks at Investigational study sites to ensure compliance with GCP, ICH, applicable regulations and company SOPs for ACADIA managed clinical trials. This individual will be tasked with reviewing clinical data and essential documents for the Trial Master File, completing clinical monitoring deliverables, and maintaining productive Sponsor relationships with investigational study sites and CSPs.

Primary Responsibilities:

  • Review/monitor, and track, and manage all study related tasks at Investigational study sites
  • Manage CRO monitoring performance through the use of monitoring metrics and trip report review
  • For CRO managed trials, assist with timely reconciliation of data queries and implementation of process improvement/corrective action when needed
  • Oversee and manage clinical site monitoring activities on behalf of the study team
  • Co-monitor site pre-study, initiation, routine monitoring, and study closeout visits with CSP CRA to assess CSP and site performance for studies managed by a CRO
  • Participate in quality and process improvement initiatives to ensure monitoring efficiency and data quality
  • Assist with the collection, review, and tracking of site-specific study/essential documents
  • Performs ongoing reconciliation of the Trial Master File (TMF) with content from site files
  • Provide training to site personnel and CSP CRA personnel, as required
  • Tracks and reports progress of study sites
  • Responsible for quality data from study sites for ACADIA managed trials and ensures appropriate source documentation, training, and accurate transcription of data into the study Case Report Form (CRF) as evidenced by minimal data query rates
  • Participate in team meetings
  • May take meeting minutes, develop and maintain study trackers, or assume other tasks to support study team
  • Assists with creation and review of study tools/documents
  • May require minimal travel up to approximately 20%

Education/Experience/Skills:

  • 2-5 years pharmaceutical clinical research experience
  • Requires a Bachelors degree (BA, BS or BSN) from a four-year college/university in a scientific discipline or equivalent combination of education and work experience
  • CNS experience a plus
  • Knowledge of GCP/FDA/ICH regulations required
  • Have an extensive and broad understanding of clinical research
  • Have a working knowledge of the relevant SOPs
  • Have tactful interpersonal and communication skills to establish professional working relationships with colleagues and site personnel.
  • Be able to identify and solve problems
  • Attention to detail with the ability to prioritize and multi-task
  • Must have strong organizational skills with planning and follow-through skills
  • Ability to work well under pressure and with tight schedules
  • Ability to exercise judgment within generally defined practices and policies for obtaining data
  • Self-direction and motivation are mandatory
  • MS Word, Excel, in-depth knowledge of other presentation programs a plus

Scope:

Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined policies and procedures to determine appropriate actions and resolve a variety of issues. Normally receives general instructions on routine work, detailed instructions on new projects or assignments.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.


PI114795963

<b>ACADIA Pharmaceuticals</b><br/><br/>ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity</em><br/><br/><p><strong><u>Position Summary:</u></strong></p> <p>The Senior Clinical Research Associate (in-house) will review/monitor, and track, and manage all study related tasks at Investigational study sites to ensure compliance with GCP, ICH, applicable regulations and company SOPs for ACADIA managed clinical trials. This individual will be tasked with reviewing clinical data and essential documents for the Trial Master File, completing clinical monitoring deliverables, and maintaining productive Sponsor relationships with investigational study sites and CSPs.</p> <p><strong><u>Primary Responsibilities:</u></strong></p> <ul> <li>Review/monitor, and track, and manage all study related tasks at Investigational study sites</li> <li>Manage CRO monitoring performance through the use of monitoring metrics and trip report review</li> <li>For CRO managed trials, assist with timely reconciliation of data queries and implementation of process improvement/corrective action when needed</li> <li>Oversee and manage clinical site monitoring activities on behalf of the study team</li> <li>Co-monitor site pre-study, initiation, routine monitoring, and study closeout visits with CSP CRA to assess CSP and site performance for studies managed by a CRO</li> <li>Participate in quality and process improvement initiatives to ensure monitoring efficiency and data quality</li> <li>Assist with the collection, review, and tracking of site-specific study/essential documents</li> <li>Performs ongoing reconciliation of the Trial Master File (TMF) with content from site files</li> <li>Provide training to site personnel and CSP CRA personnel, as required</li> <li>Tracks and reports progress of study sites</li> <li>Responsible for quality data from study sites for ACADIA managed trials and ensures appropriate source documentation, training, and accurate transcription of data into the study Case Report Form (CRF) as evidenced by minimal data query rates</li> <li>Participate in team meetings</li> <li>May take meeting minutes, develop and maintain study trackers, or assume other tasks to support study team</li> <li>Assists with creation and review of study tools/documents</li> <li>May require minimal travel up to approximately 20% </li> </ul> <p><strong><u>Education/Experience/Skills:</u></strong></p> <ul> <li>2-5 years pharmaceutical clinical research experience</li> <li>Requires a Bachelors degree (BA, BS or BSN) from a four-year college/university in a scientific discipline or equivalent combination of education and work experience</li> <li>CNS experience a plus</li> <li>Knowledge of GCP/FDA/ICH regulations required</li> <li>Have an extensive and broad understanding of clinical research</li> <li>Have a working knowledge of the relevant SOPs</li> <li>Have tactful interpersonal and communication skills to establish professional working relationships with colleagues and site personnel.</li> <li>Be able to identify and solve problems</li> <li>Attention to detail with the ability to prioritize and multi-task</li> <li>Must have strong organizational skills with planning and follow-through skills</li> <li>Ability to work well under pressure and with tight schedules</li> <li>Ability to exercise judgment within generally defined practices and policies for obtaining data</li> <li>Self-direction and motivation are mandatory</li> <li>MS Word, Excel, in-depth knowledge of other presentation programs a plus</li> </ul> <p><strong><u>Scope:</u></strong></p> <p>Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined policies and procedures to determine appropriate actions and resolve a variety of issues. Normally receives general instructions on routine work, detailed instructions on new projects or assignments.</p> <p><strong><u>Physical Requirements:</u></strong></p> <p>While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.</p> <p><em><br/></em></p> <img src="https://analytics.click2apply.net/v/nVoJpNuY55PyHExahwxNa"> <p>PI114795963</p>

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Posted: 2019-10-23 Expires: 2019-11-23

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Temporary Senior Clinical Research Associate

ACADIA Pharmaceuticals
San Diego, CA 92101

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