Clinical Research Associate/Sr. Clinical Research Associate

1 month ago

india KlinEra Global Services Full time

About KlinEra: Established in 2005, KlinEra provides innovative, customized clinical trial and research services to conduct ethical and efficient clinical trials that will accelerate delivery of novel therapeutic treatments with faster patient access.

KlinEra has extensive experience in a diverse number of therapeutic areas for last two decades. Thorough understanding of specific therapeutic area ensures compliance and facilitates optimal delivery. Our unsurpassed network of Key Opinion Leaders and established relationship with Investigators enables expedited enrolment and quality results, also we have maintained very high regulatory standards which helped us successfully accomplish multiple global projects.


Job Responsibilities of a CRA:


The Clinical Research Associate (CRA) will report directly to the Clinical Operations Manager and will serve as the primary representative and point of contact for the clinical sites participating in KlinEra’s clinical research studies upon site activation.


The CRA will be responsible for conducting Qualification, Initiation, Interim Monitoring and, Close-Out Visits and will also be responsible for overall site management driving recruitment, enrolment and, quality performance at the clinical sites in accordance with GCP, ICH and KlinEra’s SOPs.


The CRA may attend Investigator Meetings and may participate in feasibility assessments, process development and eTMF quality assurance. May also be involved in study start-up activities including the sending, tracking, collection, and review of regulatory documents leading to a timely study start-up.


Essential Duties:


Monitoring


  • Monitoring clinical studies of investigational and approved products remotely and through on-site visits. This may include qualification, initiation, interim monitoring, and close out site visits.
  • Acting as primary liaison between the study site staff and KlinEra Monitoring studies by reviewing and reporting on the following: site recruitment efforts, enrolment and subject status, findings at monitoring visits, protocol deviations/exceptions, serious adverse events and laboratory abnormalities.
  • Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues.
  • Meet with the Principal Investigator at the end of the visit to provide any updates and discuss findings and concerns.
  • Processing or overseeing transmission of study data according to protocol-specified timelines
  • Reviewing data queries and listings and working with the study site staff to resolve data discrepancies
  • Overseeing the study site staff to assess protocol compliance and appropriate data collection including proper handling, storage and shipment of biological samples or imaging scans.
  • Maintaining consistent contact with the study site staff, including investigators, coordinators, and other individuals involved in the clinical study.
  • Timely visit report writing and site correspondence according to the Monitoring Plan and KlinEra’s SOPs.
  • Training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion Document/Supply Tracking.
  • Managing the preparation, collection and maintenance of trial regulatory documents.
  • Ensures the clinical sites are communicating to their IRB/EC appropriately, filing documents accurately in the Investigator Study Files (ISF) and reviewing files to ensure all appropriate documentation is present.
  • Reconciliation of the ISF with the KlinEra internal eTMF to ensure both files are complete and accurate.
  • Performing drug accountability at the SIV of the initial drug supply shipment and reviewing accountability records for proper disposition and dispensing of investigational product per the protocol thorough study conduct.
  • Working with clinical site staff on investigational product discrepancy resolution and documentation.
  • Working with the clinical sites for re-supply orders of investigational product, as necessary.
  • Conducting final investigational product reconciliation and accountability at the Study Close Out Visit and packing and shipping of investigational product returns to the drug depot.
  • Managing the reporting of serious adverse events. Ensuring clinical sites report SAEs appropriately and within timelines.
  • For IND Safety Reports, ensures the clinical site receives and reports the reports to the IRB and files in the ISF.
  • May have responsibility for managing and overseeing study site start up activities including sending, receiving and reviewing essential documents for study start up in a timely manner.


Communications/Management


  • Visit report writing and site correspondence including Confirmation Letters, Follow Up Letters, PSV, SIV, IMV and COV reports and providing to the Manager in a timely manner.
  • Interacting with clinical site study team through formal communications, including providing updates, identifying issues, sharing of information and instructions.
  • Participate in mandatory CRA meetings with the Manager and will also maintain regular communication with the Manager to report on site performance, including recruitment efforts and enrolment metrics.
  • Ensuring the clinical site has proper resources in personnel, facilities and supplies to conduct the trial according to the protocol, GCP and ICH guidelines.
  • May conduct co-monitoring, training and audit visits.
  • May support the Manager in the creation of visit report templates.
  • Managing all aspects of the on-site conduct of a clinical study.
  • May communicate with the central laboratory, imaging core laboratory or other vendors to help with resolution of site to vendor issues.


Preferred Skills, Qualifications, or Technical Proficiencies


  • Detail oriented.
  • Extensive Phase I, II, and III experience in oncology trials is mandatory.
  • Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills.
  • Flexibility with changing priorities.
  • Ability to efficiently perform and prioritize multiple tasks.
  • Extensive knowledge of Indian regulations and their practical implementation.
  • Willingness to travel up to 80% regionally and on occasion cross-country.
  • Computer proficiency in Microsoft Word, Excel, and PowerPoint.

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