Kate Sharples

Clinical Research Associate - Covance, Inc

**** ***** **** - **********, ** 27215

aca1ab@r.postjobfree.com - 856-***-****

Experienced Clinical Research Professional currently looking for opportunities to expand

therapeutic experience and add to work-related responsibilities. Wanting to use strong

organizational, team, and leadership skills to progress in the industry.

Skill Highlights

• Able to work within a team. • File audit experience.

• Excel with individual tasks and • Managing multiple investigator sites.

responsibilities. • Regulatory document collection and

• ICH GCP trained. review.

• Therapeutic experience in Cardiology • Note-to-file generation.

(CAD-Stent), Oncology (EAP for • Shipping nationwide.

GIST), Anemia and Kidney Disease • Experience with study close-out

(IDA in Hemodialysis-Dependent processes and requirements.

CKD) and Rheumatology • Submissions to Central IRB for multiple

(Fibromyalgia and RA). study sites.

• Excellent communication skills. • Skilled in Critical Thinking, Root Cause

• Data management capabilities; query Analysis, and problem solving.

review and resolution, as well as ad- • Knowledge of risk-based monitoring.

hoc report generation.

• Facilitate manual grant runs and grant

payment tracking.

WORK EXPERIENCE

Clinical Research Associate

Covance, Inc - Conshohocken, PA - September 2012 to Present

Responsible for all aspects of study site monitoring including routine monitoring and close- out of clinical

sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance; liaise with

vendors; and other duties, as assigned

• Responsible for aspects of registry management as prescribed in the project plans

• General On-Site Monitoring Responsibilities:

o Ensure the study staff who will conduct the protocol have received the proper

materials and instructions to safely enter patients into the study

o Ensure the protection of study patients by verifying that informed consent

procedures and protocol requirements are adhered to according to the applicable regulatory requirements

o Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by

careful source document review

o Monitor data for missing or implausible data

o Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring

tasks in an efficient manner, according to SOPs and established

guidelines, including managing travel expenses in an economical fashion according to Covance travel policy

• Prepare accurate and timely trip reports

• Perform CRF review, query generation and resolution against established data review

guidelines, with or without direct supervision, on Covance or client data management

systems, as assigned by management

• Assist with the administration of clinical research projects, recruiting investigators,

collecting investigator documentation and site management

• Provide coverage for clinical contact telephone lines, as required

• Update, track and maintain study-specific trial management tools/systems

• Generate and track drug shipments and supplies, as needed

• Track and follow-up on serious adverse events as assigned

• Implement study-specific communication plan as assigned

• Attend investigators' meetings, project team meetings and teleconferences, as needed

• Assist Senior Clinical Research Associate in managing investigator site budgets

• Perform other duties as assigned by management

Clinical Research Assistant

Covance, Inc - Conshohocken, PA - August 2011 to September 2012

Provide clinical support for projects according to Covance Standard Operating Procedures, ICH

Guidelines and GCP

•Develop and/or maintain tracking systems for clinical projects

•Assist in monitoring responsibilities as assigned by supervisor

•Act as contact for project team and study sites

•Perform CRF review, query generation and resolution against established data review guidelines, under direct

supervision on Covance or client data management systems, as assigned by management

•Assist with generation and reconciliation of queries to investigative sites/clients to resolve

problem data

•Provide coverage for Clinical contact lines, as required

•Assist with the management of study supplies and organize shipments

•Create, update, track, and maintain study-specific trial management files, tools, and systems

•Assist the local project team members with other administrative activities as required (e.g.

payments to investigators, correspondence with clients, preparation of status reports, and organization of

investigators' meetings)

•Assist with collection, review, tracking and preparation of regulatory documents as required

•Co-ordinate meetings with clients, investigators, and project team, including taking minutes

•Ensure compliance with Covance SOPs, FDA, ICH, and GCP regulations for clinical conduct in all aspects

of daily work

•Provide input in writing Monitoring Conventions as assigned

•Assist in submissions and notifications to Ethics Committees and Regulatory Authorities

General Monitoring Responsibilities:

•Assist Senior CRAs, CRA-2 and CRA-1 with monitoring tasks as required and according to training goals (e.g.

review of Case Report Forms and Study File Notebook, drug accountability)

•Assist with all aspects of study site monitoring including in-house site monitoring, routine

monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits,

EDC review (where applicable); liaise with vendors with direct supervision from

Clinical Research Associates 1 and 2, Sr. Clinical Research Associates, Project Managers or

Project Directors

•Perform other duties as assigned by management

Therapeutic Area Experience

Cardiovascular: Coronary Artery Disease, Device/Coronary Stent (Phase IV)

Musculo-Skeletal: Fibromyalgia (Phase IV), Rheumatoid Arthritis (Phase III)

Oncology: Gastrointestinal Stromal Tumors (Phase IV - EAP Program)

Anemia: Iron Deficiency Anemia, CKD/Hemodialysis (Phase IV)

EDUCATION

Bachelor of Arts in Biology

Rutgers University - Camden, NJ

2011

Associate of Arts in General education

Burlington County College - Pemberton, NJ

2009

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