Remote: Sr. CRA / Clinical Trial Lead (232131)

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Job Description:

 

Our client is looking for Sr. CRA / Clinical Trial lead with 3-5+ years of monitoring and at least 2 years of clinical lead experience. This professional will support the VP in overseeing and implementing necessary monitoring-related project activities and will ensure that assigned clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

 

Primary responsibilities (Not limited to):

 

  • Assures compliance with local regulations, Code of Federal Regulations (CFR) / International Conference of Harmonization (ICH) / Good Clinical Practice (GCP) guidelines, and company / sponsor SOPs.
  • Critically evaluates monitoring effectiveness. Collaborates planning techniques to ensure efficient monitoring and corrective plan implementation when necessary.
  • Maintains awareness of key study performance indicators for all study sites. Updates study and subject status information.
  • Anticipates and identifies potential issues. Implements corrective action. Provides guidance to resolve complex issues.
  • Collaborates with clinical study team to successfully carry out study objectives.
  • Oversees and manages multiple ongoing protocols.
  • Assists with review, escalation and follow up of patient issues including safety, registration, and visits.
  • Assists with reviewing country and site specific ICFs.
  • Oversees routine reviews of study eTMF and portals for accuracy and completeness. Ensures proper documentation / filing practices are being maintained.

 

Job Requirements:

 

Skills:

  • Clinical Research Associate 
  • Clinical Trial Lead
  • Oncology (min 2 years) 
  • Phases I,II,III and expanded study experience 
  • Experience in management of vendors and global sites

Location: Remote 

Duration: 6 Months +

Start Date: 12/5

Education: BS/BA degree or equivalent (background in life sciences preferred)

 

Remote: Sr. CRA / Clinical Trial Lead (232131)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
12/5
Location
Remote

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