Senior Clinical Research Associate
Worldwide Clinical Trials
Warsaw, Poland
1 d. temu

Worldwide Clinical Trials have an exciting opportunity for a permanent strong CRA II or Senior Clinical Research Associate (SCRA) with general CNS experience.

This is ideally based from our Warsaw office but can be home-based if located in another major City such as Krakow, Lodz.

SUMMARY : Responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs).

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 personnel. RESPONSIBILITIES : Tasks may include but are not limited to : Perform feasibility studies for potential sites as requestedConduct pre-

study, study initiation and interim monitoring visits in adherence to the protocol requirementsFunction in the role of Lead CRA for global studies, coordinating CRAsDevelop a Clinical Monitoring Plan as requestedConduct site visit trip report review and provide feedback and editsProvide mentoring and guidance to less experienced CRAs and site staff when neededDesign study specific tools and templates as requestedActively participate in study team and investigator meetingsActively participate in bid defensesCreate and conduct training to study team members or colleagues as requested and appropriateWork with Project Management to evaluate deliverables and study milestonesCompile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.

g. IRB / IEC study approval, informed consent, etc.)Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study siteDocument site visit findings via written reportsProvide input into the design of protocols and CRFs as requestedAssess, monitor, and train study site staff on protocol adherence as requiredReview study subject safety information and informed consentConduct source document verification for compliance, patient safety, and veracity of dataReview CRFs using paper or electronic data capture systems and assist sites with data query resolutionAssist the site in the maintenance of the Investigator Site FileMaintain regular communication with sitesProvide applicable updates for site related documentation for filing in the Trial Master File (TMF)Ensure site compliance with IP receipt, accountability and return or destructionConduct accompanied site visits for assessment or training of other CRAs as requested and appropriateComplete final site closeout visit and report Perform other duties as assigned.

The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-

inclusive. OTHER SKILLS AND ABILITIES : Excellent oral and written communication skillsExcellent planning and organizational skills with effective time managementExcellent interpersonal skillsDemonstrate initiative and problem-

solving skillsAbility to lead and motivate assigned team (if applicable)Ability to provide experience and input into process initiatives and development relating to monitoring and site management activitiesExtensive understanding of clinical research principles and processThorough understanding of FDA and / or EU Directives and regulations, ICH Guidelines and local regulatory requirementsThrough understanding of two to three therapeutic areas sufficient to function as a Lead CRA as appropriateThorough understanding of standard operating proceduresProficiency in Microsoft OfficeProficiency with IxRS, EDC systems REQUIREMENTS : Medical Doctor (MD) degree or Pharmacist (MSPH, PharmD, Ph.

D., or equivalent Pharmacy degree, etc. ) and with a minimum experience of three years as a Clinical Research Associate ORA minimum four-

year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science and a minimum experience of five years as a Clinical Research Associate, ORTwo-

year college curriculum or equivalent education / training (nursing degree or equivalent life science degree preferred) and a minimum of seven years as a Clinical Research AssociateWillingness to travel requiredValid current passport requiredDriving license requiredFluent in the local languages of the countries under responsibilities and proficient in both spoken and written English #L1-JM1

Worldwide Clinical Trials have an exciting opportunity for a permanent strong CRA II or Senior Clinical Research Associate (SCRA) with general CNS experience.

This is ideally based from our Warsaw office but can be home-based if located in another major City such as Krakow, Lodz.

SUMMARY : Responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs).

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 personnel. RESPONSIBILITIES : Tasks may include but are not limited to :

  • Perform feasibility studies for potential sites as requested
  • Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements
  • Function in the role of Lead CRA for global studies, coordinating CRAs
  • Develop a Clinical Monitoring Plan as requested
  • Conduct site visit trip report review and provide feedback and edits
  • Provide mentoring and guidance to less experienced CRAs and site staff when needed
  • Design study specific tools and templates as requested
  • Actively participate in study team and investigator meetings
  • Actively participate in bid defenses
  • Create and conduct training to study team members or colleagues as requested and appropriate
  • Work with Project Management to evaluate deliverables and study milestones
  • Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.
  • g. IRB / IEC study approval, informed consent, etc.)

  • Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site
  • Document site visit findings via written reports
  • Provide input into the design of protocols and CRFs as requested
  • Assess, monitor, and train study site staff on protocol adherence as required
  • Review study subject safety information and informed consent
  • Conduct source document verification for compliance, patient safety, and veracity of data
  • Review CRFs using paper or electronic data capture systems and assist sites with data query resolution
  • Assist the site in the maintenance of the Investigator Site File
  • Maintain regular communication with sites
  • Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)
  • Ensure site compliance with IP receipt, accountability and return or destruction
  • Conduct accompanied site visits for assessment or training of other CRAs as requested and appropriate
  • Complete final site closeout visit and report
  • OTHER SKILLS AND ABILITIES :

  • Excellent oral and written communication skills
  • Excellent planning and organizational skills with effective time management
  • Excellent interpersonal skills
  • Demonstrate initiative and problem-solving skills
  • Ability to lead and motivate assigned team (if applicable)
  • Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities
  • Extensive understanding of clinical research principles and process
  • Thorough understanding of FDA and / or EU Directives and regulations, ICH Guidelines and local regulatory requirements
  • Through understanding of two to three therapeutic areas sufficient to function as a Lead CRA as appropriate
  • Thorough understanding of standard operating procedures
  • Proficiency in Microsoft Office
  • Proficiency with IxRS, EDC systems
  • REQUIREMENTS :

  • Medical Doctor (MD) degree or Pharmacist (MSPH, PharmD, Ph.D., or equivalent Pharmacy degree, etc. ) and with a minimum experience of three years as a Clinical Research Associate OR
  • A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science and a minimum experience of five years as a Clinical Research Associate, OR
  • Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree preferred) and a minimum of seven years as a Clinical Research Associate
  • Willingness to travel required
  • Valid current passport required
  • Driving license required
  • Fluent in the local languages of the countries under responsibilities and proficient in both spoken and written English
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