A Division of P&E Associates Limited, Inc.
14902 Preston Road, #404-744, Dallas, TX 75254   Phone: 972-517-1254   FAX: 775-252-7109

Clinical Trials Staffing

Patient Outreach Recruitment

Pat Sanders, Senior Project Manager

Responsible for design and execution of all pre and post market clinical studies. Ensures all deadlines, schedules and budgets are met while keeping in compliance with client/sponsor requirements

Additional responsibilities of the PM include:

  • Creates project plans, coordinates project activities and schedule status, budget, training of local labor consultants and preparation of deadlines.
  • Implements and monitors clinical studies in accordance with client’s requirements or SOP’s, reviews protocol, develops and creates project budgets.
  • Provides guidance and mentoring to the project team members and staff for each trial.
  • Develops, reviews, and protocols. Develops all monitoring and data management plans, and project details.
  • Manage all queries from the sponsor.
  • Directs all site training and for study related devices, data collection systems and medications

Directs, coordinates, and administers the planning, research, and development of projects, field research opportunities, development of new ventures based upon best case scenario for city. Prioritizes projects and develops timelines for clinical trials. Develops, manages, and implements field research projects and testing to assess best outreach to African Americans.

Ed Sanders, Associate Project Manager

Coordination of Consultants, tracking projects. Manages the day-to-day operations of the multiple clinical trials. Manages the administration of the Projects policies, procedures and programs. Administrative and office support activities for multiple cities, fielding telephone calls, receiving and directing inquiries, research and communication with project coordinators in study cities. Conducts counting and analysis of data, develops support staff, in-the-field labor, administration of field research, counting and preliminary analysis of each city’s field research program to access clinical trial participants.

Portia Tucker, Data Management Consultant

Experience leading and directing Data Management. Responsible for directing and supervising all activities associated with the data management activities, processes and overall integrity of databases.

Other responsibilities includes:

  • Leads and direct the patient Data bases, and coordinates activities in order to meet project deliverables prior to pre-screening
  • Captures and analyzes data from participant surveys, cleans the data, and lock databases in a timely manner

  • Support of outsourced labor in site cities and data validation prior to implementation of databases
  • Oversees the supervision of CRO data management activities, and works with project leaders and recruitment team members
  • Provides data management, analysis and designs
  • Works with Data Entry and Charting patient progression into pre-screening

Develops templates for entry, setting up and entering contact (only- not medical) data from all sources, summarizing results from each network or city and charting for delivery to project management team. Data used for developing client databases of prospective patients.

Uche Ojeh, IT Director/Coordinator

Handles services for graphic and internet design , Monitors and maintain the web site and computer databases, Internet development and electronic networks for the project, providing support, including procedural, documentation. Tests and evaluates new technology for outreach.

Tanya Beaudoin, IT Associate

Handles web site functionability of web site, data collection of opt-in participants

Lark Godwin, Research and Development Consultant

Liaison with Sr. Project Manager. Researches (local) educational facilitators and literature for programs for clinical trials education. Networks with community leaders (each community is different) within each site city, developing ongoing educational projects that can be distributed to networks and community/religious leaders' constituencies utilized for interest in recruitment.

Veronica Mackey, Media Consultant

Develops public service educational outreach to minority audiences. Coordinates Labor, transportation, advertising expenses.

Targeted responsibilities for Ethnic community and media outreach.

  • Conducts media research for best outlets to African American audiences
  • Works with the local partners and team to develop PR objectives and advertising strategy
  • Liaisons with the creative agency team, to develop media strategies and campaigns
  • Makes decisions on the best form of media for specific cities and campaigns
  • Develops media outreach specific to geographical locations
  • Researches and analyzes media to translate ideas into a quantifiable task
  • Identifies target audiences and best media outreach
  • Presents proposals, with media and cost schedules
  • Proofreading advertising text and press releases for content prior to release;
  • Maintaining detailed collection of published media and clipping services
  • Develops evaluation for media outreach campaigns.

Cynthia Manker, Media (and community) Coordinator

Develops community and media outreach opportunities; seeks opportunities for outreach to and partnerships with networks. Coordinates media advertising contract labor, upgrades,

Pamela Collins, Project Outreach Coordinator

Manages Team for planning and development of African American outreach and special event activities; develops support program activities including liaison with community and network coordinators, collaborators and program business development. Coordinates with local networks to develop and maintain continuity plans, develops social networking opportunities to recruit for clinical trials. Works with community and religious leaders to establish a thorough, comprehensive field research for recruitment.

Betty Richards, Project Coordinator

Handles Coordination of Consultants, tracking expenses. Manages the day-to-day operations of the project management. Manages the administration of the Projects policies, procedures and programs. Administrative and office support activities for multiple cities, fielding telephone calls, receiving and directing inquiries, word processing, filing, and faxing. Software skills and Internet research communication with cities.

Coordinates On-the-ground (local) consultants to assist with local outreach activities in each city. Seeks local celebrities, media opportunities, and network partnerships to advance program goals.

Network Coordinators

( 103 Black Organization Affiliates and 32 NBLIC coalitions nation-wide). Selected based upon site cities. Assists with identification of people, organizations and events in cities that have resources to assist in identifying clinical trial participants, or local opportunities to recruit for specific disease therapies. They are usually a part of a health network, and familiar with African American populations, events, churches and activities in cities, professional relationship with hospitals and community leaders.

Nurse Consultants

African American nurse consultants who assist with calling and follow-up with potential patients. Reviews pre-screening requirements for trials. Conducts preliminary pre-screening interviews to establish comfort level with potential candidates, answers general questions about disease condition (education) and directs participant to pre-screening location. Manages call center and provides telephone assistance for follow up with patients, and physicians; conducts periodic surveys and outreach to program participants.

Staff Consultants for Full Service Direct Trials

Dr. Michael Daniels, Medical Director/Consultant

Reviews Protocols, oversees Project Management activities, makes recommendation on African American physicians and networks for referrals, develops medical outreach for national clinical trials projects.

Francis Jones

Capabilities to seek out and find qualified African American physicians, train on protocol and track and report progress to client. Since most African Americans are more comfortable being treated  by and near black doctors, duties include:

  • Capabilities to target and ID African American physicians in multiple cities for multiple studies.
  • Capability to help devise rescue plans for quickly moving into city for identifying existing obstacles to minority recruitment
  • Coordinating with existing on-the-ground minority patient recruitment and community outreach, and combine minority investigators’ existing community participation in clinical trial to help give client/sponsor direct increase in underrepresented and minority populations (African Americans, Latino and Asians).
  • Working with physicians and clinical practices who serve minority, underrepresented, and women patient populations.
  • Provides community based clinical trial investigators that have a variety of clinical trial experience.
  • Conducts site investigator site selection, investigator and staff training, investigator site initiation, patient/subject recruitment, budget management, physician data management, study drug management, site monitoring, regulatory readiness, project management, quality assurance, study closeout.
  • Provides metrics as a result of monitoring of sites

Bill Stoval

Monitors the administration and progress of clinical trials sites for project. Depending upon complexity of clinical trial activities, Typical work activities includes:

  • Developing and writing trial protocols (outlining the purpose and methodology of a trial)
  • Conducts selection of minority and African American physicians in urban populous
  • Training minority doctors in protocol, monitoring for adherence to protocol
  • Presenting trial protocols to a sites
  • Designing data collection forms, or case record forms (CRFs)
  • Coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects
  • Managing regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
  • Locating and assessing the suitability of facilities at a study center
  • Liaising with doctors/consultants (or investigators) on conducting the trial
  • Setting up the study centres, which includes ensuring each centre has the trial materials and training site staff to trial-specific industry standards
  • Training site staff to industry standards
  • Monitoring the trial throughout its duration, which involves communicating or visiting the study centers
  • Verifying that data entered on to the CRFs is consistent with patient clinical notes, or source data/document verification (SDV)
  • Collecting completed CRFs from hospitals and general practices
  • Writing visit reports
  • Filing and collating trial documentation and reports
  • Ensuring all unused trial supplies are accounted for
  • Closing down study centers on completion of the trial
  • Discussing results with a medical statistician, who writes technical trial reports
  • Preparing final reports

Also, we utilize medical and clinical vendors specializing in outreach to African Americans and Ethnic Minorities