Project Management

Rebecca E. Cope, PMP

Director Musculoskeletal and Metabolic Disorders

Contact Information Address: 23 Lower Hilltop Rd.

Yardley, Pa. 19067

Phone: 215-***-****

Email: ***********.******@*****.***

Education

• George Washington University

o Bachelor of Science Clinical Research Administration June 2003

• Pennsylvania State University

o Bachelor of Science Education 1982-1985

Professional Experience

BioClinica Inc. – Newtown, PA (May 2004-Present)

Project Director Musculoskeletal and Metabolic Disorders

Primary Responsibilities

Provides leadership by;

• Demonstrating professional and collaborative conduct

• Outlines expectations for ethical conduct for the group

• Developing and delivering or facilitating team training

• Establishing team performance expectations and guidelines

• Analyzing team performance for consistency/quality within established project guidelines

• Collaborating with the departmental managers for team coaching/mentoring

• Managing the Project Managers and Projects Assistants’ assignments, delegating appropriate and challenging assignments to encourage growth, development and independence.

Identifies project guidelines and communication needs by;

• Establishing clear and measurable project operating guidelines

• Defining timelines, milestones and limitations for project inter-departmental team members

• Establishing project reporting schedules and providing project and portfolio updates in a timely manner

Performs management and analysis by;

• Identifying critical project success factors for tracking, analysis and reporting

• Determining needed resources for project completion and communicating needs to appropriate departmental managers

• Collaborating with department leaders for appropriate training of those involved with an eye toward excellence in successful and timely completion of project(s)

• Developing budget and expense review strategies

• Creating proactive cost containment strategies and communicating them to project team

• Understanding SOPs and working closely with QA for clarification and documentation of deviations

• Training and maintaining project team knowledge and applications of SOPs

• Communicating all protocol clarifications/revisions to project team

• Coordinating site management of data collection with internal and external teams

Therapeutic Experience

Imaging Modality experience • Areas of Therapeutic experience ( a sampling of indications)

o A range of musculoskeletal and metabolic abnormalities

Medical devices specifically targeted toward correction of skeletal abnormalities

• Vertebral deformities and augmentation

• Appendicular deformities

Genetic-bone related deformities

Osteoporosis

Osteogenesis Imperfecta

Multiple Myeloma

Metabolic disorders

HIV

Obesity

Endometriosis

o A range of oncology indications

Renal Cell

Lymphoma

Breast cancer

• Imaging Modality experience (prior to current position)

o DXA-10 yrs

o X-ray-12 yrs

o CT-1.5 yrs

o PET/CT minimal

o MRI-2.0 yrs

o Nuc Med-.5 yrs

o Ultrasound-minimal

Licensure, Certifications, and Memberships

Historical affiliations • Project Management Professional-PMI# available on request

• PMI member

• ASBMR Densitometry committee member

• ISCD Training committee member

• Bone Densitometry Professionals Network

• NIH Human Participation Protections Education certification (2003)

• SOCRA-Society of Clinical Research Associates (2004)

• ARRT-The American Registry of Radiologic Technologists (since 1997)

Relevant Skills

• Knowledge and understanding of all aspects of clinical trial development (Phase I- Phase IV) as well as thorough training in CFRs and SOPs, GCP and GMP, ICH standards and Serious Adverse Event reporting requirements.

• Established expertise in providing efficacy, safety, imaging, and statistical recommendations for protocol development.

• Developed imaging guidelines for multiple imaging modalities, created numerous study-related forms and procedures.

• Identified investigational sites and assisted in site initiation activities and participated in ongoing monitoring activities.

• Developed study-specific tracking procedures and data collection as well as query resolution activities.

• Management skills that include the establishment of excellent internal and external communication, development of efficient processes and documentation of procedures, identification of project challenges and ongoing oversight that ensures the successful completion of projects.

• Consistently provides professional presentations to large groups at Investigator meetings, and inter-departmental meetings as well as ongoing project status meetings and management review meetings.

Contact this candidate