Sheryl Jenkins Email and Phone Number

Participating in a multi-center trial to prevent subsequent osteoporotic fractures after a hip fracture. Oversee and review routine site activities including; site selection, initiation, periodic monitoring of source documents, informed consent process, drug accountability and compliance, review of investigator and regulatory files and conduct close out visits according to the trial-specific monitoring plan protocol, regulatory requirements, and SOP’s Document routine site management and clinical monitoring activities. Manage and review case report form (CRF) completion and submission, data query resolution, and overall data integrity. Identify and report safety concerns, protocol deviations or unexpected data trends. Assist sites with preparation for planned and unannounced audits. Provide routine updates to trial supervisor(s) and other assigned contacts. Participate as a trainer and mentor for subordinates, peers, and site personnel.Develop site training materials, including site initiation activities, agendas, slides, and study tools.

Duke Clinical Research Institute, Durham, NCMarch 2006 – September 2006Contract CRA: Participation in a multi-center trial to prevent subsequent osteoporotic fractures after a hip fracture. Responsibilities include: management and review routing of moderately complex data including case report forms completion and submission, data query resolution, and overall data integrity according to SOP’s with minimal to no guidance. Recommend improvements for data collection and data processing. Participate in team meetings, sharing information, and proactive problem identification and resolution. Act as the point person for trial-specific activities. Provide routine updates and reports to trial supervisor(s) regarding study issues and resolutions and trial activities.

ClinForce, Durham, NCGlaxo-Smith-Kline, Durham, NCContract CRA: August 2005 - November 2005Responsible for managing 3 -CRO’s for global oncology trials. Responsible for study start up activities; coordinate and plan Investigator meeting, review feasibility questionnaires, recruitment projections, assist in CRF design. Responsible for project meetings agendas and appropriate communication of study progress.Quality Staffing, Durham, NCPPD Development, Morrisville, NCContract CRA: Jan 2005 - July 2005 Participation in the conduct of a multi-center psoriasis registry. Responsible for site management of multiple sites, including site selection, site initiation and interim monitoring. Review of regulatory documents. Review of data via EDC.

Johnson and Johnson Family of CompaniesThe Robert Wood Johnson Pharmaceutical Research Institute, Raritan, New Jersey Local Trial Manager Oct 2003 - Feb 2004 Responsible for quality, timeliness and overall study performance of a large pediatric Phase III program. Evaluate Investigator feasibility for study participation. Participated in planning investigator meetings/presentations, monitor CRO's and other vendorsSenior CRAMay 2000 - Responsible for monitoring study sites and study issues associated with multiple pediatric phases I - III and phase III Wound Care trials in accordance with ICH/GCP regulations, clinical protocol and SOPs. Activities included site selection Clinical Report Form development. Investigator meeting presentations, collection of initial and ongoing regulatory documents, recruitment efforts, Investigator payments, SAE/AE review, and electronic Data capture.Johnson and Johnson Family of CompaniesThe Robert Wood Johnson Pharmaceutical Research Institute, Raritan, New JerseyClinical Data CoordinatorNov 1990 - May 2000Created and executed data edit/query programs, assisted in Case Report Form design. Developed review guidelines, coded adverse events. Interacted with multifunctional teams to ensure accurate data quality.