The Project Manager (PM) is the primary C5Research contact for all the organizations involved in the conduct of the trial.. The PM works with all project team members to ensure problem identification and resolution and adherence to study timelines. C5Research Site Managers provide a clinical resource to clinical trial sites. The PM and site managers identify and help resolve recruitment and retention issues, provide clinical information and education to maximize protocol understanding and adherence, and provide “peer-to-peer” communication.

C5Research Project and Site Managers collaborate with the Principal Investigator and team members to write study protocols, identify and select study sites, create and manage executive, steering and data safety monitoring committees, create educational tools and reference materials, engage in proactive and routine communication to sites, conduct investigator meetings and coordinator conference calls, address "lessons learned" and share experiences of best practices across sites.

Our Project and Site Managers have extensive clinical and research experience and expertise which prepares them to assist in the successful implementation and conclusion of cardiovascular clinical trials.

Protocol and CRF Development
With world-renowned physician researchers, C5Research can provide expert clinical and research input into protocol development. C5Research Project and Site Managers, who are well-versed in Good Clinical Practices and ICH guidelines and current clinical practice, provide essential input into the feasibility of clinical trials and ease of recruitment. C5Research has access to the extensive resources of over 500 Cleveland Clinic physicians and researchers who can provide valuable input throughout the protocol and CRF development phase.

Data Safety Monitoring Board, Executive and Steering Committees
C5Research assists in the selection, management and coordination of Data Safety Monitoring Boards (DSMB), Executive Committees (EC) and Steering Committees (SC), and creates the charters/guidelines to make these committees operational.

Site Selection and Clinical Site Management
C5Research maintains a growing site database of experienced clinical research personnel who can be considered for trial participation. C5Research works closely with the Sponsor to develop protocol-specific criteria to identify and select study sites. To evaluate their potential for successful participation in the trial, each site is sent an initial survey which identifies capabilities and resources.

C5Research Project and Site Managers support the clinical trial sites through communication and education to promote successful recruitment and retention of study subjects. A daytime or twenty-four hour clinical hotline service is available to provide immediate access to clinical resources for subject management, potential un-blinding or other clinical questions.

Contact:
Jean Cross, MSN, RN - Manager, Project and Site Management
(216) 445-6396
crossj @ ccf.org