27 days old

Temporary Senior Clinical Study Assistant

ACADIA Pharmaceuticals
Princeton, NJ 08540
  • Job Code
    114795999
ACADIA Pharmaceuticals

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

Position Summary:

Supports Clinical Study Managers and teams with administrative duties to manage clinical trials (Phases I IV) to ensure that studies are carried out according to the protocol, SOPs, ACADIA policies and procedures and applicable regulations and principles of Good Clinical Practice (GCP).

Primary Responsibilities:

  • Provides day-to-day departmental/project support activities with primary responsibility for filing and maintaining the Clinical Trial Master Files (TMF), which includes review of received and in-house generated documents for accuracy and completeness
  • Files documents according to ACADIA procedures
  • Responsible for oversight if function is outsourced to a CRO
  • Assist Clinical Study Manager with oversight of third party vendors if function is maintained by ACADIA
  • Processes clinical records and forms; updates and maintains clinical trackers;reports site/study status to the Clinical Study Team
  • Reviews required site essential study documents and files them as appropriate to remain in section readiness during the conduct of a study
  • Identifies potential compliance gaps as instructed
  • Organizes study information on the shared file drives and retrieves information from the CRO portals, if available
  • Prepares study and site regulatory binders and miscellaneous study materials
  • Coordinates the distribution of communications to all sites (e.g. questionnaires, newsletters, mass mailings, etc.)
  • Submits required documentation for completion the Appendices of a Clinical Study Report (CSR) or inclusion into a regulatory filing
  • Sets up and attends meetings, takes meeting notes, and updates and distributes meeting minutes
  • Assists the study teams with financial tracking and reporting
  • Processes forms, requests for information by the team, and requests to obtain information from vendors and investigator sites
  • Organizes and helps plan meetings. May interact with meeting planners and travel agents
  • Performs other duties as assigned

Education/Experience/Skills:

Associates degree. Equivalent combination of relevant education and applicable job experience may be considered. A minimum of 6 years progressively responsible experience in administrative support with a focus on clinical trials. Pharma or biotech experience required.

Must possess:

  • Knowledge of ICH-GCP guidelines and FDA regulations preferred
  • Experience in biotechnology or clinical study research
  • Ability to work under tight timelines
  • Ability to interact professionally with external resources
  • Strong, flexible interpersonal and communication skills (written and verbal)
  • Strong organizational skills with attention to detail and ability to multi-task
  • Ability to take initiative and willingness to learn new things
  • Ability to work independently as well as part of a project team
  • Demonstrated analytical skills and problem solving abilities
  • Proficiency in Microsoft Office Suite
  • Able to effectively share information and ideas within and outside of department in written and verbal form; able to put forth own ideas and gain understanding from others
  • Proficient at supporting effective interactions between team members and among cross-functional teams
  • Demonstrated ability to schedule and coordinate project priorities and resources and to produce accurate, high quality work

Scope:

As a skilled specialist, completes tasks in a resourceful and effective manner. Will be required to work on assignments requiring considerable judgment and initiative. Proposes best methods and procedures on new assignments. May be informal team leader among peers.

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. Employee must occasionally lift and/or move up to 15 pounds. Occasional business travel (few times per year) may be required.


PI114795999

<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>Supports Clinical Study Managers and teams with administrative duties to manage clinical trials (Phases I IV) to ensure that studies are carried out according to the protocol, SOPs, ACADIA policies and procedures and applicable regulations and principles of Good Clinical Practice (GCP).</p> <p><strong><u>Primary Responsibilities:</u></strong></p> <ul> <li>Provides day-to-day departmental/project support activities with primary responsibility for filing and maintaining the Clinical Trial Master Files (TMF), which includes review of received and in-house generated documents for accuracy and completeness</li> <li>Files documents according to ACADIA procedures</li> <li>Responsible for oversight if function is outsourced to a CRO</li> <li>Assist Clinical Study Manager with oversight of third party vendors if function is maintained by ACADIA</li> <li>Processes clinical records and forms; updates and maintains clinical trackers;reports site/study status to the Clinical Study Team</li> <li>Reviews required site essential study documents and files them as appropriate to remain in section readiness during the conduct of a study</li> <li>Identifies potential compliance gaps as instructed</li> <li>Organizes study information on the shared file drives and retrieves information from the CRO portals, if available</li> <li>Prepares study and site regulatory binders and miscellaneous study materials</li> <li>Coordinates the distribution of communications to all sites (e.g. questionnaires, newsletters, mass mailings, etc.)</li> <li>Submits required documentation for completion the Appendices of a Clinical Study Report (CSR) or inclusion into a regulatory filing</li> <li>Sets up and attends meetings, takes meeting notes, and updates and distributes meeting minutes</li> <li>Assists the study teams with financial tracking and reporting</li> <li>Processes forms, requests for information by the team, and requests to obtain information from vendors and investigator sites</li> <li>Organizes and helps plan meetings. May interact with meeting planners and travel agents</li> <li>Performs other duties as assigned</li> </ul> <p><strong><u>Education/Experience/Skills:</u></strong></p> <p>Associates degree. Equivalent combination of relevant education and applicable job experience may be considered. A minimum of 6 years progressively responsible experience in administrative support with a focus on clinical trials. Pharma or biotech experience required.</p> <p>Must possess:</p> <ul> <li>Knowledge of ICH-GCP guidelines and FDA regulations preferred</li> <li>Experience in biotechnology or clinical study research</li> <li>Ability to work under tight timelines</li> <li>Ability to interact professionally with external resources</li> <li>Strong, flexible interpersonal and communication skills (written and verbal)</li> <li>Strong organizational skills with attention to detail and ability to multi-task</li> <li>Ability to take initiative and willingness to learn new things</li> <li>Ability to work independently as well as part of a project team</li> <li>Demonstrated analytical skills and problem solving abilities</li> <li>Proficiency in Microsoft Office Suite</li> <li>Able to effectively share information and ideas within and outside of department in written and verbal form; able to put forth own ideas and gain understanding from others</li> <li>Proficient at supporting effective interactions between team members and among cross-functional teams</li> <li>Demonstrated ability to schedule and coordinate project priorities and resources and to produce accurate, high quality work</li> </ul> <p><strong><u>Scope:</u></strong></p> <p>As a skilled specialist, completes tasks in a resourceful and effective manner. Will be required to work on assignments requiring considerable judgment and initiative. Proposes best methods and procedures on new assignments. May be informal team leader among peers.</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. Employee must occasionally lift and/or move up to 15 pounds. Occasional business travel (few times per year) may be required.</p> <p><em><span style="font-weight: 400;"><br/></span></em></p> <img src="https://analytics.click2apply.net/v/Z4PzoycyzzmRsxqmIbzy7"> <p>PI114795999</p>

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

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Temporary Senior Clinical Study Assistant

ACADIA Pharmaceuticals
Princeton, NJ 08540

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