Posted 151 Days Ago Job ID: 1883774 6 quotes received

Clinical Research Associate

Fixed Price
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Administrative & Secretarial Legal Assistance

Independently manages multiple global clinical trials of moderate complexity. The CRA is expected to manage all sites and vendor related issues, with supervision from the Clinical Operations Team. Simultaneously manages all aspects of multiple global clinical studies 

(Phase I through IV).

Job Responsibilities:

 

  • Schedule, Plan and Conduct Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
  • Write Reports and Investigator Follow-up Letters for Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
  • Site Management Activities: Provide Project Updates to team members and project management; Confirm that Regulatory applications have been submitted and approvals received; Organize delivery of investigational product, laboratory packs, CRFs and other study specific materials to and from the clinical sites; Review study documents for compliance with protocol, ICH GCP guidelines and for Protocol Deviations/Violations and Waivers, Review study documents for subject safety events; Escalate Issues at site to project management.
  • Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Participates in the planning of quality assurance activities and coordinates resolution of audit findings.
  • To lead and partake in regular team meeting / teleconferences
  • Participates in the planning of quality assurance activities and coordinates resolution of audit findings
  • To lead and partake in regular team meeting / teleconferences
  • Assist, as appropriate, with reporting site performance regarding timelines and deliverables the clinical project team meetings and assist with feedback information on study organization and conduct for analysis of overall study performance.
  • Mentoring the Associates on the subjects of job performance, trainings and professional growth
  • Report to Project Manager the progress and status of all the projects.
  • Train and mentor Clinical Operations team on monitoring, internal procedures and query resolution.
  • Assist in development and implementation of clinical processes, procedures and programs. 
  • As per the project requirement monitor (pre-study, initiation, routine, and close-out visits) investigator sites for GCP compliance according to SOPs and/or client guidelines.
  • Perform QC of internal documents and reports that are sent out to sites, Sponsors and Vendors.
  • Act as point of contact for the Site and Labs for all the project specific queries. 
  • Troubleshoot any issue and escalate / take assistance of operation team for smooth resolution.
  • Participates in the selection of study vendors for assigned studies
  • Maintains frequent and meaningful contact with the vendor/ sites to assess performance and provide guidance as needed.
  • Develop and manage study timelines (including recruitment) and may develop and manage program timelines
  • Participates in the selection of investigational sites with input from Clinical/Medical Operations and vendors
  • Proactively identifies project risks and resolves with some supervision
  • Oversees clinical trial sites’ adherence to pertinent regulations through review of monitoring reports, communications with investigators, study site personnel, and other designee personnel
  • Oversees the maintenance of trial-related and essential documents to the Trial Master File
  • Provide or facilitate training to clinical study teams on assigned protocol specific topics
  • Work closely with other teams in the organization, e.g. quality, regulatory, medical writing, statistics etc.
  • Provide input into non-project related activities and development of department processes, procedures, and guidelines as requested

Required Education:

Bachelor Degree in biomedical sciences or related scientific discipline, Relevant Certification Courses for CRA role would be advantage

Required Experience: Minimum 2 yrs with  monitoring for a CRO

Job Location: Anywhere USA

Type of Employment :  Contractual Basis

 

Other Requirements: 

REQUIREMENTS

 

  • Minimum of 2-3 years of clinical research monitoring experience at a CRO and/or pharmaceutical/biotech organization.
  • Previous experience negotiating vendor/site contracts and managing the budgets
  • Thorough understanding of FDA, EMEA, ICH and GCP guidelines
  • Experience with Phase I – IV clinical trials
  • Proven complex problem solving skills
  • Solid vendor management skills, e.g. CRO, Laboratory & Clinical supply logistics
  • Broad understanding of clinical operations related to clinical development functions
  • Detailed understanding of all aspects of clinical protocol design and implementation & overall drug development
  • Ability to effectively interface with medical personnel at clinical site(s)
  • Ability to lead multi-disciplinary, cross-functional teams both internally & externally
  • Detail and team oriented with excellent cross-functional team and participation skills
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficiency with computer programs including Microsoft Office
  • Ability and willingness to travel 70% of the time (internationally and domestically) 
  • Proficiency in handling technical assets like laptop, MS office, Outlook, IWRS, RMP, eCRF etc
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