9 days old

Senior Clinical Research Associate - Temporary

ACADIA Pharmaceuticals
Princeton, NJ 08540
  • Job Code
    119217605
ACADIA Pharmaceuticals

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

For the safety of our employees and communities in response to COVID-19, ACADIA has implemented a temporary work from home policy. As a part of this shift, we have migrated all interviews to virtual interviewing via phone and video.

Position Summary:

This position is an in-house based position and will participate in the management of clinical trial sites, and oversees clinical monitoring activities (through Clinical Service Providers [CSP] or directly) by ensuring compliance with regulations, protocol(s), SOPs and overall clinical objectives. Reviews clinical data, essential documents for the Trial Master File, clinical monitoring deliverables and assists with maintaining productive Sponsor relationships with Investigational study sites and CSPs.

Primary Responsibilities:

  • Oversee and manage clinical site monitoring activities on behalf of the study team. Prepare/review monitoring plans and create monitoring requirements, in conjunction with the clinical study managers
  • Conduct site pre-study, initiation, routine monitoring, and study closeout visits for ACADIA managed clinical trials
  • 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
  • Review/monitor, 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
  • Participate in quality and process improvement initiatives to ensure monitoring efficiency and data quality.
  • Manage CRO monitoring performance through the use of monitoring metrics and trip report review
  • 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
  • Primary contact for study site personnel for ACADIA managed clinical trials
  • 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.
  • For CRO managed trials, assist with timely reconciliation of data queries and implementation of process improvement/corrective action when needed
  • Assist with review of protocols, amendments and clinical study reports
  • Participates in planning or administering training to CSP CRAs and investigator sites at Investigator Meetings.
  • Participate in team meetings
  • Participates in the development and review of source documents, Case Report Forms, edit checks, and may participate in User Acceptance Testing for various systems used in Clinical Research
  • May take meeting minutes, develop and maintain study trackers, or assume other tasks to support study team
  • Coordinates, assembles, and ships study related supplies as needed
  • Assists with creation and review of study tools/documents
  • Maintains awareness of overall developments in the field of clinical research and clinical monitoring based on current literature, attendance at professional meetings, continuing education, etc
  • Will require up to approximately 40% business travel both domestically and internationally

Education/Experience/Skills:

Requires a Bachelors degree (BA, BS or BSN) from a four-year college or university in a scientific discipline or equivalent combination of education and work experience plus minimum of five years pharmaceutical clinical research 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. May require travel up to 40% both domestic and international.

PI119217605

<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 style="text-align: center;"><strong>For the safety of our employees and communities in response to COVID-19, ACADIA has implemented a temporary work from home policy. As a part of this shift, we have migrated all interviews to virtual interviewing via phone and video.</strong></p> <p><strong><u>Position Summary:</u></strong></p> <p>This position is an in-house based position and will participate in the management of clinical trial sites, and oversees clinical monitoring activities (through Clinical Service Providers [CSP] or directly) by ensuring compliance with regulations, protocol(s), SOPs and overall clinical objectives. Reviews clinical data, essential documents for the Trial Master File, clinical monitoring deliverables and assists with maintaining productive Sponsor relationships with Investigational study sites and CSPs. </p> <p><strong><u>Primary Responsibilities:</u></strong></p> <ul> <li>Oversee and manage clinical site monitoring activities on behalf of the study team. Prepare/review monitoring plans and create monitoring requirements, in conjunction with the clinical study managers</li> <li>Conduct site pre-study, initiation, routine monitoring, and study closeout visits for ACADIA managed clinical trials</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>Review/monitor, 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</li> <li>Participate in quality and process improvement initiatives to ensure monitoring efficiency and data quality.</li> <li>Manage CRO monitoring performance through the use of monitoring metrics and trip report review</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>Primary contact for study site personnel for ACADIA managed clinical trials</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>For CRO managed trials, assist with timely reconciliation of data queries and implementation of process improvement/corrective action when needed</li> <li>Assist with review of protocols, amendments and clinical study reports</li> <li>Participates in planning or administering training to CSP CRAs and investigator sites at Investigator Meetings.</li> <li>Participate in team meetings</li> <li>Participates in the development and review of source documents, Case Report Forms, edit checks, and may participate in User Acceptance Testing for various systems used in Clinical Research</li> <li>May take meeting minutes, develop and maintain study trackers, or assume other tasks to support study team</li> <li>Coordinates, assembles, and ships study related supplies as needed</li> <li>Assists with creation and review of study tools/documents</li> <li>Maintains awareness of overall developments in the field of clinical research and clinical monitoring based on current literature, attendance at professional meetings, continuing education, etc</li> <li>Will require up to approximately 40% business travel both domestically and internationally</li> </ul> <p><strong><u>Education/Experience/Skills:</u></strong></p> <p>Requires a Bachelors degree (BA, BS or BSN) from a four-year college or university in a scientific discipline or equivalent combination of education and work experience plus minimum of five years pharmaceutical clinical research experience. </p> <ul> <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. May require travel up to 40% both domestic and international.</p> <img src="https://analytics.click2apply.net/v/Z4abM4H1G4p7cxqmIbzy7"> <p>PI119217605</p>

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Posted: 2020-03-21 Expires: 2020-04-21

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Senior Clinical Research Associate - Temporary

ACADIA Pharmaceuticals
Princeton, NJ 08540

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