1. Jamie D. Gross 3610 Eastman Drive OKC, OK 73112
Jamiedgross@gmail.com 405.200.7597
Summary
Acts as a core project team member representing clinical delivery with the customer. Responsibilities
include managing the operational aspects of projects to meet contractual requirements in accordance
with SOPs, policies and practices; ensuring delivery of study quality and patient recruitment; driving site
compliance; and leading, mentoring and training the clinical operations team.
An experienced manager of clinical teams and CRAs, study protocol implementation, training and
development, main focus is providing project oversight of the clinical team, contributing to and ensuring
implementation of the protocol, clinical monitoring plan, site monitoring and drug accountability
materials, training documents and data management/collection plans.
Education
BA from University of Oklahoma, Norman, OK 1995 - 2000
Experience
QuintilesIMS, Overland Park, KS (homebased)
Clinical Lead Oct 2016 - Present
 Collaborate with project leader to establish an integrated set of plans
 Represent clinical delivery with customer
 Produce and distribute status reports for the core project team, other functional groups and
senior management
 Ensure appropriate subject recruitment plans are in place and all outreach or digital offerings
are explored and deployed in consultation with the customer
 Ensure the Site Recruitment Action Plan (SRAP), patient recruitment target and contingency
plans are in place and deployed at trigger points
 Deliver the project according to the quality management plan
 Guide CRAs and advise on critical specific study issues
 Manage clinical study set-up, maintenance and follow-up activities through ongoing tracking
and review of study progress, and report progress to appropriate clinical management and
project management forums
 Accountable for approving final sites' lists
 Develop the risk management plan from a clinical perspective and coordinate clinical issue
escalation and resolution with the Project Leader
 Collaborate with other functional groups such as Global Delivery Network (GDN), Labs, Data
Management, Pharmacovigilance and Biostatistics to support milestone achievement and to
manage study issues and obstacles
 Provide ongoing training and support to the clinical team
 Conduct frequent team meetings and ensure regular communication
 Drive high performance and efficiency of the clinical team through CRA project objectives and
the conduct of monitoring visits, providing performance feedback to management on clinical
team members
 Collaborate with the Site Network Manager and the CRA Resource Manager on CRA
development

2.  Participate in proposal development and sales/proposal presentations
 Mentor and coach new peers as they assimilate into their roles
 Attend site visits as applicable in support of project delivery
Quintiles, Overland Park, KS (homebased)
Clinical Project Manager Sep 2014 – Sep 2016
 Work with cross-functional project teams to support milestone achievement and help manage
study obstacles
 Coordinate open contact with the sponsor to ensure effective two-way communication
 Report monitoring performance to management
 Oversee study monitors through regular review of site communications, monitoring visit reports
and quality assurance audit findings to resolve issues, implement corrective action plans and
escalate findings to management, while providing input to line managers of monitor
performance
 Collaborate with other functional groups to support milestone achievement and manage study
issues
 Foster monitor success through scheduling co-monitoring site visits and mentoring CRA team
Quintiles, Overland Park, KS (homebased)
Senior Clinical Research Associate Feb 2006 – Sep 2014
 Perform site selection, initiation, monitoring and closure in accordance with contracted scope of
work and good clinical practice
 Provide monitoring visits and site management for a variety of protocols, sites and therapeutic
areas
 Administer protocol and related study training to staff and establish regular lines of
communication with sites to manage ongoing project expectations and issues
 Evaluate the quality and integrity of study site practices related to the conduct of the protocol
and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL)
 Manage the progress of assigned studies by tracking regulatory submissions and approvals,
recruitment and enrollment, case report form (CRF) completion and submission, and data query
generation and resolution.
 Create and maintain appropriate documentation regarding site management, monitoring visit
findings and action plans by submitting regular visit reports and other required study
documentation
 Act as a mentor for staff by conducting training and audited visits
 Assist CTL with design of study tools, documents and processes
Duke Clinical Research Institute, Raleigh, NC
Clinical Research Associate Jan 2002 – Feb 2006
 Perform site selection, initiation, monitoring and closure in accordance with contracted scope of
work and good clinical practice
 Provide monitoring visits and site management for a variety of protocols, sites and therapeutic
areas
 Administer protocol and related study training to staff and establish regular lines of
communication with sites to manage ongoing project expectations and issues

3.  Evaluate the quality and integrity of study site practices related to the conduct of the protocol
and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL)
 Manage the progress of assigned studies by tracking regulatory submissions and approvals,
recruitment and enrollment, case report form (CRF) completion and subission, and data query
generation and resolution.
 Create and maintain appropriate documentation regarding site management, monitoring visit
findings and action plans by submitting regular visit reports and other required study
documentation
Oklahoma Foundation for Cardiovascular Research
Clinical Research Coordinator Jun 1998 – Dec 2001
 Conduct clinic trials from initiation through closure with a focus on patient education
entrollment, recruitment and retention
 Perform report submission to local and central regulatory and advisory boards
 Created and maintained patient-focused articles, brochures and advertisements
 Created foundation’s white paper to generate government funding
Systems Skills
 Microsoft Suite (Excel, Powerpoint, etc)
 Medidata RAVE
 Inform
 Oracle Clinical
 RighTrack
 eTMF
 IWRS/IVRS
 Infosario
Licenses and Certifications
 Certified Clinical Research Coordinator/CCRC (former), 2001
 Barnett Accreditation – Expert GCP Exam for Managers and Staff interacting with investigational
sites - 2012
 Barnett Accreditation – Expert GCP Exam for Managers and Staff interacting with investigational
 sites - 2014
Barnett Accreditation – Expert GCP Exam for Managers and Staff interacting with investigational
sites - 2016