Clinical Operations Manager

Key Responsibilities:

Oversee Clinical Research Associate (CRA) and all associated monitoring activities.  Provide leadership and oversight to Clinical Research Organizations (CROs) ensuring compliance to responsibilities as outlined in the transfer of obligations and in accordance with CRO and sponsor policies, procedures, SOPs, ICH/GCP guidelines.

 

Compass Consulting Experience:

  • Bachelor’s degree in nursing.
  • 7+ years of clinical trial monitoring and management with industry leading Biotech and emerging start-up companies.

Skills:

  • Proven leadership in CRO bid defense discussions and ability to provide insight and content into contracts and scope of work.
  • Participate in issue escalation and governance committees for CROs and vendors.
  • Ability to partner with senior leadership, and other applicable departments, in the development, review and implementation of departmental SOPs and business improvement innovation initiatives.

Key Accomplishments:

  • Managed operation of clinical research sites, site selection, initiation, regulatory, patient enrollment, site maintenance, patient follow up, and study close out for PMA and 510(k) dialysis access trials.
  • Proctored and trained investigators and staff during surgical implant for study enrollments and interventional follow up events.
  • Coordinated site enrollment strategies and spearheaded referral outreach programs.

 

If you would like more information about this candidate, please contact us at requests@compasscgroup.com

Meet Your Recruiter

Lisette Cruz

Lisette Cruz is an enthusiastic business developer and recruiter, holding more than 10 years of experience working with various companies here in the Bay Area. She enjoys identifying and meeting critical needs between candidates and clients, and feels rewarded when she can help each attain their goals. By acutely assessing the needs of both, and finding the intersection between the two, she is able to forge new partnerships by utilizing tandem networks and resources. With great interpersonal skills and the ability to genuinely care about the growth and well-being of individuals and companies, she looks forward to establishing long lasting, successful partnerships between current and future connections.
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