Karen Correa, Phd Email & Phone Number

Ingelheim Am Rhein, Rhineland-Palatinate, De

Camden, New Jersey, Us

Tokyo, Jp

Cranbury, New Jersey, Us

Philadelphia, Pa, Us

New York, New York, Us

Paris, France, Fr

Paris, France, Fr

•Manage, document, plan an organizational change within a 400+ staff department under the direction of the US Clinical Research Unit Vice President.•Collaborate with all cross functional management teams within the US Clinical Research Unit (medical advisors, Qualitative and Quantitative operations, regional and safety departments) and external partners (ICTM, legal, finance) to design and implement goals and programs for the development of clinical project leaders. •Work with CPLs and appropriate team members to develop efficient processes to support the achievement of study timelines and metrics. •Assist the Medical Director(s) in overseeing their therapeutic department and study needs. •Ensure project training in drug development and project management best practices.•Implement mentoring and career/talent development procedures to ensure increased productivity and decreased staff turnover levels. •Drive issue identification and resolution of people management issues.

Paris, France, Fr

•Served as the liaison between the Medical Advisor, Clinical Project Leaders and Regional Management team to address regional project related issues, resources, and priorities. •Attended, assisted with planning and execution of weekly CPL meetings, “key” investigator meetings, and other meetings as appropriate. •Use IMPACT and CTI tools to track workload and proactively plan and assign regional resources to meet project needs. •Provide overview of trial preparations and progress to regional management team; align training events to avoid overlap with other project teams. •Communicate project related training initiatives to regional team. •Managed the RCRA Point People efforts to meet study and performance objectives. Manage RCRA point person: conduct field monitoring observation visits; assist in selection of appropriate professional training courses; offer counsel on issues related to SOPs, regulations and resolution tactics for site issues/concerns.

Wilmington, Massachusetts, Us

•Directs and is accountable for the leadership and management of all activities of Charles River Laboratory Clinical Monitoring staff and assist in the design, implementation, monitoring, evaluation, and reporting of clinical trials. •Provide direction, guidance and mentoring to 10 monitoring staff members and 2 Regional managers with 12+ CRAs reporting to them, including driving performance management, career development and salary recommendations. •Work with clinical monitoring department management team to develop, implement and maintain standard operating procedures, administrative guidelines and policies, resource needs and allocation, training needs and process improvements. •Direct the process to recruit, interview and hire additional monitoring staff. •Lead the interdepartmental task force as Global Respiratory Therapeutic Lead and process improvement/implementation teams.

•Provided global management during clinical programs and assured that strategic program needs, resource allocations, and budgets were addressed through ongoing program reviews.•Provided comprehensive program management support for all stages of product development and all aspects of study execution in variety of therapeutic areas such as Oncology, Cardiovascular, and Respiratory. •Supervised, evaluated and mentored Lead Clinical Research Associates, Clinical Research Associates and Clinical Project Assistants with a staff of 15+. •Reviewed staffing reports and FTE projection reports. •Presented at client presentations and proposals. •Conducted new CRA and Lead CRA training, and development activities. •Drive study-level timelines and metrics to meet or exceed contractual agreements.•Conducted vendor management.•Accountable for ensuring high-quality and timely data entry into Remote Data Capture (RDC) database for complex clinical studies including Oncology studies.

•Oversaw ongoing clinical trials of investigational drugs/devices and ensured compliance with FDA regulations and GCPs. •Developed and assisted others in developing protocols, IFCs, CRFs and CRF instructions, monitoring plan, training materials and other monitoring tools. •Planned and coordinated the efforts of other CRAs in the development and approaches for site selection, investigator meetings, and study status and subject enrollment strategies. •Assumed Lead CRA and project leadership responsibilities for selected global clinical trials. Responsibilities included: monitoring the study budget and other monitoring activities, reviewing and escalating issues of monitoring visit reports, evaluating and tracking subject enrollment for entire project, and providing protocol training of other CRAs. •Supervised, evaluated and mentored CRAs. Established goals and objectives for team members. Reviewed and approved timesheets, expense reports and travel authorizations.

•Collaborated with Project Management to ensure successful completion of clinical research projects. Assisted in the process of selecting sites to participate in clinical trials of investigational drugs/devices. •Oversaw ongoing clinical trials of investigational drugs/devices, ensured compliance with FDA regulations and Good Clinical Practices. •Assured the integrity of clinical data with respect to accuracy, accountability, documentation and methods or procedures through review of CRFs, source documents and medical records. •Assisted with the development of training materials and other monitoring tools.

•Coordinated, organized and executed adult and pediatric clinical trials within the following therapeutic areas such as allergy, asthma and OTC analgesics.•Completed study visit activities, CRFs, drug dispensation logs, regulatory submissions, etc.•Coordinated extensive activities with subject recruitment in challenging populations and determined eligibility to multiple studies within allergy and asthma.•Trained and mentored newly hired Study Coordinators. •Maintained communication with the sponsoring company throughout study while preparing and submitting amendments, continuing reviews, study staff updates, and closure to accrual documentation to the IRB.

• Provided genetic laboratory research utilizing top loading and analytical balances. Operated spectrophotometer (UV/visible), low and super speed centrifuge, and Betagen 603 blot analyzer. Prepared molar and normal solutions commonly used in molecular biology, differential and gradient centrifugation agarose polyacrylamide gel electrophoresis. Handled and extracted DNA and RNA, purification and quantitation. Handled electrophoresis of proteins.

Pharmaceutical Management Certificate

Phd, Health Sciences

Ms, Health Services Administration

Bs, Biology