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Become A Clinical Trials Specialist

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Working As A Clinical Trials Specialist

  • Getting Information
  • Establishing and Maintaining Interpersonal Relationships
  • Making Decisions and Solving Problems
  • Organizing, Planning, and Prioritizing Work
  • Updating and Using Relevant Knowledge
  • Mostly Sitting

  • $120,160

    Average Salary

What Does A Clinical Trials Specialist Do At HCA, Hospital Corporation of America

* Plan the execution and monitor the completion of complex Phase I assigned clinical research protocols.
* Including abstracting, assembling and organizing research data while monitoring adherence to the clinical protocol and preparing reports on the data.
* Will work closely with the physician principal investigator, manager of drug development data operations, clinical trial sponsor and study team.
* Duties and Responsibilities:
* Duties include but are not limited to:
* Leads the execution of trials for the research team.
* Collects, completes and enters data into study-specific case report forms or electronic data capture systems within 10 days of patient visits.
* Confirm patient eligibility and discuss discrepancies with nursing staff and physicians
* Verify screening procedures are performed within the protocol specified window
* Enroll 1
* patients per week
* Monitor patient toxicity on trial according to Common Toxicity Criteria, including adding data to logs from source, confirming grades assigned by nursing staff, and ensuring consistency of data across the medical record
* Planning and tracking of all assigned clinical activity in the lifecycle phases of the start up, interim and close out.
* Educates Research Nurses and clinic staff on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments
* Creates study specific tools for source documentation including eligibility worksheets, screening checklists and intense sampling worksheets capturing vitals, ECGs, blood and tumor sampling
* Ensures pharmacist has clinical and drug supplies.
* Interfaces with laboratory technician for lab kits and processing.
* Tracks and reports adverse events, serious adverse events, protocol waivers, deviations and violations.
* Participates in monitor visits monthly for each trial assigned.
* Reviews source documentation and queries for missing documentation.
* Maintains case report forms tracking management database.
* Reviews trial data for clinical relevance and answers appropriate queries.
* Apprises research scientists and Drug Development Management team of all study specific medical issues for guidance.
* Assists sponsor and US FDA audit teams.
* Reviews and responds to any monitoring and auditing findings and escalates issues defined by Project Manager.
* Archives study documentation and correspondence per company policy.
* Participates in sponsor meetings when applicable.
* Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects.
* Adhere to professional standards and SOP's established for clinical research.
* Practice and adhere to the "Code of Conduct" philosophy and "Mission and Value Statement".
* Monitors and maintains accurate and complete information concerning study cohort, slot allocation, toxicity and response on trial.
* Required to be present in weekly department meetings to review every trial and patient in the DDU.
* Responsible for reporting on dates of cohorts opening, number of slots allocated to SCRI as well as other sites and dates of all patients starting treatment.
* Timely and accurate completion of Serious Adverse Events approximately 2 per week.
* Assist to ensure physician oversight by updating on protocol issues prior to updating the sponsor and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events.
* Intense sponsor interaction including daily phones calls and e-mails to update on patient status as well as toxicity and response.
* Participant in weekly teleconferences with sponsors to update on patients including last visit, any toxicity, and response.
* Responsible for sending notification out to department before and after calls to update staff.
* Responsible for noting any significant toxicity, particularly protocol defined dose limiting toxicities and notifying drug development management team as well as sponsor.
* Responsible for following patient's response to treatment according to RECIST criteria in real time to assist in treatment decisions.
* Responsible for ensuring Site Visit Outlines are accurate for assigned trials as well as input reminders for nursing staff to minimize clinic error.
* Mandatory:
* Practices and adheres to the “Code of Conduct” philosophy and “Mission and Value Statement”
* During your employment with SCRI you will be routinely assigned training requirements.
* You are expected to complete any training assignments by the due date.
* Competencies:
* Knowledge:_ /A body of information needed to perform a tasks; May be obtained through education, training or experience /
* o Must have an understanding of analyze clinical trial data.
* o Knowledge of FDA guidelines and GCP is required

What Does A Clinical Trials Specialist Do At Vanderbilt University Medical Center

* Implementation and ongoing tracking and materials management of existing and future tissues, archives, which includes surgical pathology and autopsy tissues, slides, blocks, and related information.
* Documentation of send out, return, condition, andavailability of tissue slides, blocks, and other samples, maintenance ofelectronic and paper files related to the tissue samples, management ofinformation associated with the archival specimens, and prospectivearchiving of new samples.
* Responsible for prospective data management
* Integrate electronic data with StarPanel, StarBRITE,CaTissues, and CTSA grant-supported resources.
* Develop and maintain standard operating proceduresrelated to the scope and activities of the position.
* Develop standard operating procedures.
* Maintain standard operating procedures.
* CA

What Does A Clinical Trials Specialist Do At Bristol Myers Squibb

* Works with the Orencia Program Team Lead, the Full Development Team Lead, and matrix team members to translate the Orencia FDT strategy into protocols and action plans.
* Works with the relevant leaders to author clinical protocols and related documents, including clinical study reports, clinical regulatory documents including integrated summaries and clinical overviews.
* In collaboration with pharmacovigilance, designs and implements safety monitoring plans
* Provides key contributions to clinical documents and deliverables in support of regulatory submissions.
* Monitors one or more clinical trials for safety and experimental rigor
* Reviews and cleans data from clinical trials
* Addresses relevant clinical queries from study sites and authors responses to study related IRB and HA questions
* Cultivates relationships with thought leaders and investigators, and gathers input on disease areas and design of clinical programs.
* Provides clinical support to medical affairs and commercial colleagues

What Does A Clinical Trials Specialist Do At Volt Information Sciences

* Maintain list of labs, assays & studies (CDx & Dako/Agilent-sponsored
* Set up site Study binders (Investigator Master File), & other documents for CDx-related studies
* Office support for OOO Clin.
* Ops. staff during lab site visits.
* Assist with the development of applicable tools, templates and processes, PowerPoint presentations and Excel spreadsheets related to projects & updates
* Support & assist with data entry and quality control review of documents & data forms related to Dako/Agilent-sponsored trials
* Assist with remote data monitoring a necessary
* Assist with IRB/IEC submissions for Dako/Agilent-sponsored trials cover letters, review applications, oversee submission process & approvals
* Assist with MCA QMS management & revisions, in particular tracking of reviews & approvals
* Performs ongoing QC of paper TMF & eTMF

What Does A Clinical Trials Specialist Do At System One Services

* Maintain global operational tracking and reporting systems andtools including but not limited to he study/project budget andfinancial management data), YourDOCeS (invoices), IMPACT (updates forplanned/concept studies), ShareDoc PhlexGlobal (eTMF documents), Quality RiskIndicator systems, eFilia (contracts), Study drug destruction trackersetc.
* Develop study specific tracking systems if applicable.
* Provide detailed support for cost tracking (study budgets,project budgets and special events.
* Exercise clear decision making oninvoice reconciliations based on knowledge of the protocol, patientvisit design, lab draw timings and other study specific parameters thatrequire understanding of the therapeutic area specifics and studyconduct.
* Provide technical and administrative support and expertise forcontract tracking by acting as a main point of contact for contracthandling and by liaising globally with internal and external partners tofacilitate progress and identify potential issues.
* Assist with oversight of study metrics, compliance with systemsuse and present/report issues, progress, and status at global meetingsvia written and verbal communication (if applicable).
* Assist and collaborate in development of project / study relateddocuments.
* Support Clinical Study Report preparation (e.g. appendices)if applicable
* Coordinate project / study material preparation and global studycommunication internally and/or with vendors:
* Consistent and collaborative communication to internal (CSM,cPharm, GCS –ECL, OPL, STM, CLM, CRA, etc.) and external partner (CRO,Laboratory, etc.)
* Create and send communications materials to countries and/orstudy sites (e.g.
* Newsletters, updates, etc.)
* Support the maintenance and construction of study specificinternet based forums, such as study websites, SharePoints, InvestigatorPortal, etc.
* Coordinate communication of project/study status to variouslevels of management

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How To Become A Clinical Trials Specialist

Natural sciences managers usually advance to management positions after years of employment as scientists. Natural sciences managers typically have a bachelor’s degree, master’s degree, or Ph.D. in a scientific discipline or a related field, such as engineering. Some managers may find it helpful to have an advanced management degree—for example, a Professional Science Master’s (PSM) degree, a Master of Business Administration (MBA), or a Master of Public Administration (MPA).

Education

Natural sciences managers typically begin their careers as scientists; therefore, most have a bachelor’s degree, master’s degree, or Ph.D. in a scientific discipline or a closely related field, such as engineering. Scientific and technical knowledge is essential for managers because they must be able to understand the work of their subordinates and provide technical assistance when needed. 

Natural sciences managers who are interested in acquiring postsecondary education in management should be able to find master’s degree or Ph.D. programs in a natural science that incorporate business management courses. A relatively new type of degree, called the Professional Science Master’s (PSM), blends advanced training in a particular science field with business skills, such as communications and program management, and policy. Those interested in acquiring general management skills may pursue a Master of Business Administration (MBA) or a Master of Public Administration (MPA). Some natural sciences managers will have studied psychology or some other management-related field to enter this occupation.

Sciences managers must continually upgrade their knowledge because of the rapid growth of scientific developments.

Work Experience in a Related Occupation

Natural sciences managers usually advance to management positions after years of employment as scientists. While employed as scientists, they typically are given more responsibility and independence in their work as they gain experience. Eventually, they may lead research teams and have control over the direction and content of projects before being promoted to an administrative position.

Licenses, Certifications, and Registrations

Although certification is not typically required to become a natural sciences manager, many relevant certifications are available. These certifications range from those related to specific scientific areas of study or practice, such as laboratory animal management, to general management topics, such as project management, and are useful to natural sciences managers regardless of the organization being managed.

Important Qualities

Communication skills. Natural sciences managers must be able to communicate clearly to a variety of audiences, such as scientists, policymakers, and the public. Both written and oral communication are important.

Critical-thinking skills. Natural sciences managers must carefully evaluate the work of others. They must determine if their staff’s methods and results are based on sound science.

Interpersonal skills. Natural sciences managers lead research teams and therefore need to work well with others in order to reach common goals. Managers routinely deal with conflict, which they must be able to turn into positive outcomes for their organization.

Leadership skills. Natural sciences managers must be able to organize, direct, and motivate others. They need to identify the strengths and weaknesses of their workers and create an environment in which the workers can succeed.

Problem-solving skills. Natural sciences managers use scientific observation and analysis to find solutions to complex technical questions.

Time-management skills. Natural sciences managers must be able to do multiple administrative, supervisory, and technical tasks while ensuring that projects remain on schedule.

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Clinical Trials Specialist jobs

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Clinical Trials Specialist Demographics

Gender

  • Female

    72.4%
  • Male

    24.9%
  • Unknown

    2.6%

Ethnicity

  • White

    77.6%
  • Asian

    11.4%
  • Hispanic or Latino

    8.3%
  • Unknown

    1.8%
  • Black or African American

    0.9%
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Languages Spoken

  • Spanish

    34.5%
  • French

    10.3%
  • Chinese

    6.9%
  • Japanese

    6.9%
  • Russian

    6.9%
  • Korean

    6.9%
  • Italian

    6.9%
  • Hungarian

    3.4%
  • Czech

    3.4%
  • Albanian

    3.4%
  • Gujarati

    3.4%
  • Hindi

    3.4%
  • Mandarin

    3.4%
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Clinical Trials Specialist

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Real Clinical Trials Specialist Salaries

Job Title Company Location Start Date Salary
Clinical Trial Head Novartis Institutes for Biomedical Research, Inc. Cambridge, MA Sep 06, 2013 $129,032
Clinical Trial Leader II Novartis Institutes for Biomedical Research, Inc. Cambridge, MA Jun 01, 2011 $126,670
Clinical Trial Head Novartis Institutes for Biomedical Research, Inc. Cambridge, MA Sep 06, 2010 $122,400
Clinical Trial Leader Novartis Institutes for Biomedical Research, Inc. Cambridge, MA Sep 08, 2016 $120,000
Clinical Trial Leader, Oncology Clinical Novartis Pharmaceuticals Corporation East Hanover, NJ Nov 28, 2012 $111,220
Global Clinical Trial Leader Genentech, Inc. South San Francisco, CA Aug 20, 2016 $103,771 -
$148,800
Clinical Trial Leader II Novartis Pharmaceuticals Corporation East Hanover, NJ Aug 31, 2015 $103,000
Clinical Trial Leader II Novartis Pharmaceuticals Corporation East Hanover, NJ Mar 16, 2015 $103,000
Clinical Trial Leader II Novartis Pharmaceuticals Corporation East Hanover, NJ Apr 29, 2013 $102,000
Clinical Trial Specialist G3 Infotek Inc. East Hanover, NJ Dec 20, 2016 $98,000
Clinical Trial Leader Novartis Institutes for Biomedical Research, Inc. Cambridge, MA Aug 15, 2014 $96,000
Clinical Trial Specialist Ultragenyx Pharmaceutical Inc. Novato, CA Sep 08, 2015 $90,000 -
$147,900
Clinical Trial Specialists Integrated Resources, Inc. Raritan, NJ Sep 09, 2015 $85,254
Clinical Trial Specialists Integrated Resources, Inc. Raritan, NJ Jun 24, 2015 $83,480
Cooelative Clinical Trials Specialist Memorial Sloan-Kettering Cancer Center New York, NY May 25, 2012 $81,736
Clinical Trials EDC Study Designer Dana-Farber Cancer Institute Boston, MA Jan 15, 2016 $80,000
Clinical Trial Specialist G3 Infotek Inc. East Hanover, NJ Dec 20, 2016 $80,000
Clinical Trial Disclosure Lead Seqirus Inc. Cambridge, MA Dec 09, 2016 $78,000
Trial Master Files Specialist Tata Consultancy Services Limited Philadelphia, PA Sep 16, 2015 $69,500
Clinical Trial Specialists Integrated Resources, Inc. Raritan, NJ May 09, 2015 $67,577
Clinical Trial Specialists Integrated Resources, Inc. Raritan, NJ Sep 05, 2015 $67,577
Clinical Trial Specialist G3 Infotek Inc. Edison, NJ Sep 23, 2015 $66,000
Clinical Trial Management System Specialist Tata Consultancy Services Limited Philadelphia, PA Sep 16, 2015 $65,500
Clinical Trial Management System Specialist Tata Consultancy Services Limited Philadelphia, PA Sep 20, 2015 $64,500
Clinical Trial Specialist Parexel International Plano, TX Oct 25, 2012 $64,261
Clinical Trial Specialist Parexel International Sunnyvale, CA Sep 30, 2012 $64,261
Clinical Trial Specialist G3 Infotek Inc. Ardsley, NY Nov 11, 2016 $60,000

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Top Skills for A Clinical Trials Specialist

ClinicalTrialProtocolsRegulatoryDocumentsProtocolDeviationsProceduresIrb/EcSafetyUpdatesPerformICFInvestigatorMeetingsCRAIch/GcpFDAClinicalResearchCROICHGuidelinesCRFCtmsDataManagementOncologyClinicalTrialsPhaseIIITrialManagement

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Top Clinical Trials Specialist Skills

  1. Clinical Trial Protocols
  2. Regulatory Documents
  3. Protocol Deviations
You can check out examples of real life uses of top skills on resumes here:
  • Reviewed clinical trial protocols and prepared clinical trial budgets in accordance with research protocol provided by Sponsors.
  • Receive and review/process completed regulatory documents from investigators and forward to the Regulatory Document Specialist for final review.
  • Recognized and recorded protocol deviations.
  • Train Investigators and clinical study staff on study procedures outlined in protocol and Electronic Data Capture Completion Guidelines.
  • Prepare and negotiate clinical site agreement on a country level Prepare and submit IRB/EC application until final approval received.

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