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Clinical Research Coordinator
Pharmaceutical Product Development (PPD)
Birmingham, United States
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!
Accelerated Enrollment Solutions (AES) is a business unit of PPD that helps biopharmaceutical companies overcome patient recruitment and research site challenges by optimizing each step in the patient journey to deliver greater speed, certainty, and control to clinical trial delivery.
As a Clinical Research Coordinator, you will be a key member impacting the development and research for therapeutics for patients.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well being of our employees.
Summarized Purpose:
Conductsatleastoneongoingclinicaltrialthatmayinvolvepatientsorhealthyvolunteers.Interactswiththeresearchsiteteamandinterdepartmentalstafftoensurepositiveinteractionswithpatientsatsiteforstudyplanning,frominitiationtocloseout.
Essential Functions:
- Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
- Providesmedicalcaretopatients,alwaysensuringpatientsafetycomesfirst.Performsalldefinedstudyactivities(i.e,informedconsent,screening,andprotocolprocedureswhichincludebutnotlimitedtovitalsigns,pregnancytests,height,weight,ECG's,etc.).
- Recordsallpatientinformationandresultsfromtestsasperprotocolonrequiredforms.
- Whererequired,maycompleteIPaccountabilitylogsandassociatedinformation.
- Reportssuspectednon-compliancetorelevantsitestaff.
- EnsuresthatIRBapprovalisobtainedpriortostudyinitiationandIRB requirementsaremetthroughoutthestudy.
- Promotesthecompanyandbuildsapositiverelationshipwithpatientstoensureretention.
- Attendssiteinitiationmeetingsandallotherrelevantmeetingstoreceivetrainingonprotocol.
- Mayberequiredtocallpatients,dopatientbookingsandfollow-upcallstoconfirmbookingsorprovideinformationorresults.
- Logs/completesinformationonsponsorsystemsandensuresallinformationprovidedisaccurate(i.e.,casereportforms,EDC,etc.)andensuresitis completedwithintimeframe.
- Gatherssourcedocuments,updatespatientfilesandnotes,alwaysensuringrelevantandmostuptodateinformationisrecorded.
- AdherestocompanyCOP/SCOP.
- Mayberequiredtodisposeofwasteaccordingtostandardsandassistinkeepingageneralneatappearanceofthefacility.
#LI-JD1
#AES
Education and Experience:
Bachelor'sdegreeorequivalentandrelevantformalacademic/vocationalqualificationintheclinical/medicalfield
Previousexperiencethatprovidestheknowledge,skills,andabilitiestoperformthejob(comparableto0to2+years’)
Knowledge, Skills and Abilities:
- Basicunderstandingoftheclinicalresearchprocess(i.e.,GCP,SOPs, informedconsent,safetymonitoring,etc.)
- Capableofworkingindependently,analyzingandworkingwithattentiontodetail,processingandprioritizingsensitivecomplexinformationandproblemsolving
- Demonstratedabilitytoexercisediscretionandsoundjudgement
- Adequatedecision-making,negotiationandinfluencingskills
- DecentcommunicationskillsandEnglishfluencywillbeanadvantage
- Decentorganizationalskills
- Essentialproficiencyinbasiccomputerapplications
- Decentinterpersonalskillstoworkinateamenvironment
Working Environment:
PPD values the health and well being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Workisperformedinanoffice/laboratoryand/oraclinicalenvironment.
Exposuretobiologicalfluidswithpotentialexposuretoinfectiousorganisms.
Exposuretoelectricalofficeequipment.
Personalprotectiveequipmentrequiredsuchasprotectiveeyewear,garmentsandgloves.
Occasionaltravel,maybedomesticorinternational.
Abilitytoworkinanuprightand/orstationarypositionfor6-8hoursperday.
Repetitivehandmovementofbothhandswiththeabilitytomakefast,simple,repeatedmovementsofthefingers,hands,andwrists.
Frequentmobilityrequired.
Occasionalcrouching,stooping,withfrequentbendingandtwistingofupperbodyandneck.
Lighttomoderateliftingandcarrying(orotherwisemoves)objectsincludingluggageandlaptopcomputerwithamaximumliftof15-20lbs.
Abilitytoaccessanduseavarietyofcomputersoftwaredevelopedbothin-houseandoff-the-shelf.
Abilitytocommunicateinformationandideassootherswillunderstand;withtheabilitytolistentoandunderstandinformationandideaspresentedthroughspokenwordsandsentences.
Frequentlyinteractswithotherstoobtainorrelateinformationtodiversegroups.
Performsawiderangeofvariabletasksasdictatedbyvariabledemandsandchangingconditionswithlittlepredictabilityastotheoccurrence.
Abilitytoperformunderstress.
Abilitytomulti-task.
Regularandconsistentattendance.
PPD Defining Principles:
We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD -
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you!
Job posted: 2022-12-04
