Clinical Research Coordinator

Elizabeth Maly

** ******** ****, **********, ** *7960

***********@******.***

Ph.: 973-***-****

CLINICAL SERVICES COORDINATOR

Accomplished and energetic Clinical Services Coordinator with a solid history of achievement in a Clinical Research Laboratory. Experience working with Contract Reach Organizations (CROs), expertly gathering and analyzing data for highly confidential Clinical Trials. Motivated leader with strong organizational and prioritization abilities. Proficient in defining and validating protocols for clinical studies and handling trial responsibility throughout the Clinical Trial within a challenging deadline. Developed and implemented new procedures for efficiency and customer service by overhauling data management procedures and providing final results to clients in an efficient manner. Well versed in cGCP, cGLP, ICH and FDA standard and regulations prior to FDA submissions. Assisted the VP, Clinical Operations, in researching clinical data for medical publications. Reformed and restructured the Client Services Division and implemented new procedures for the intake of samples for efficiency and amended the Standard Operating Procedures (SOPs).

SKILLS:

• Data-management • Time Management/Adhere to timelines

• Medical terminology • Monitoring Clinical Trials

• Written and oral communication • Attention to detail

• Coordination for Clinical Trials • Good organization and interpersonal skills

• Strong skills in MS Word and Excel • Manage multi-tasking

• Web Research • Motivated self-starter

• Strong ability to communicate effectively with

management team on all levels

EXPERIENCE:

Consumer Product Testing Company (CPTC), Fairfield, NJ 070**-****-**** Clinical Services Coordinator

2015 – 2016

• Provided administrative support to the Clinical Evaluations Division in maintaining clinical documentation control and compliance with Clinical Trials under the guidance of cGCP, cGLP and FDA standard and regulations.

• Supported Clinical Trials for CRO by providing meticulous data management.

• Provided strong communications with all Clinical Management team to effectively conduct a Clinical Trial.

• Implemented and managed trial activities from study start-up to close-out of Trial Master Files (TMF).

• Drafted and finalized clinical study protocols under the guidance of the Clinical Evaluations Division, including coordination of protocol revisions and finalization of timelines with clients.

• Developed monitoring documents such as Screening Eligibility, Subject Diaries, Case Report Forms (cCRFs) and Informed Consents.

• Prepared and submitted Investigational Review Board (IRB) related documents, including pre-study IRB submissions, and IRB Closeout Letters.

• Supported and corresponded with clients to identify site specific needs (e.g. ordering study drugs and other trial related supplies).

• Actively attended meetings and prepared agendas for pre-study clinical meetings.

• Served as backup to the Clinical Operation Coordinators in conducting Clinical Trials.

• Conducted specific departmental responsibilities as assigned by the Executive VP, Clinical Evaluations.

• Maintained scheduling and event calendars.

Manager, Client Services

2002 – 2015

• Developed and implemented new procedures for the Client Services Division by restructuring the daily routine of sample in-take from clients for an efficient turn around time. Amended the Standard Operating Procedures (SOPs) for the Client Services Division to comply with the company regulatory division. Trained and assigned responsibilities, provided support and managed the support personnel and Client Services group in accordance to the SOPs and under the Management of the Chief Operating Officer. Client Relations

• Managed the resolution of client requests as they pertain to, log-in of samples, documentation completeness and accuracy, report generation and submissions, data management of all electronic reports, Samples on Hold, and other associated issues.

• Resolved problems as they arose, and informed the Chief Operating Officer of the outcome. Staff Relations

• Managed the training of all the administrative support personnel and client services staff and ensure compliance with the current Standard Operating Procedures, and applicable regulatory requirements. Elizabeth Maly

• Provided support and resources for the staff to ensure timely and acceptable assignment completion.

• Provided timely feedback and support for the staff by means of reviews, evaluations, positive feedback and constructive and/or disciplinary actions.

Administrative Support Division

• Maintained, reviewed, and updated all office procedures, and regulatory requirements.

• Managed the workflow of projects for reporting to ensure report submission was executed in a timely manner.

Client Services

• Managed the generation of all study folders, for all departments, using the internal Booking Database.

• Reviewed and advised Information Services Department of potential issues and/or potential improvements to the Booking Database System to ensure compliance with SOP’s and current regulations.

• Coordinated the maintenance of the Client Access System (CAS) and liaison with clients where appropriate.

• Liaison with Sales on Client Service issues.

• Liaison with Accounting on Credit issues.

Upper Management Relation

• Informed, provided timely feedback, and updates to the department Directors of any unforeseen circumstances affecting client relations, and/or any issues concerning laboratory functions.

• Provided suggestions and collaborated with Chief Operating Officer/President to recognize areas for improvement, and provided corrective and preventive action items for review.

• Assisted Regulatory and Quality Assurance Division in document control changes, and implemented changes to system workflow.

• Conducted investigations into client complaints in conjunction with Directors, if applicable. Manager, Administrative Services

1996 – 2002

• Managed the Administrative Support group and appointed to assist the Client Services Division, when need.

• Trained, assigned responsibilities, provide support and managed the Administrative Services and Client Services groups as directed by the Chief Operating Officer/President.

• Created templates for report generation. Collected data for Clinical Trials and prepared final report for client submission.

• Created, maintained, and entered information into databases.

• Maintained, reviewed and updated all office procedures and regulatory requirements for which the Manager is responsible.

• Managed the workflow of projects for reporting to ensure report submission in timely manner.

• Organized and managed paper or electronic filing systems, recording information, updating paperwork, or maintaining documents such as attendance records, correspondence, of other material.

• Coordinated the flow of information, internally or with other organizations.

• Established work procedures or schedules and kept track of the daily work of clerical staff. Administrative Services

1993 – 1996

• Provided clerical support to Administrative Services and other departments as directed by the Office Manager.

• Conducted research, compiled data, and prepared reports for consideration and presentation by executives, committees and regulatory directors.

• Prepared agendas and make arrangements, such as coordinating catering luncheons for committee, board, and other meetings.

EDUCATION

Essex County College, West Essex Campus, West Caldwell, NJ Liberal Arts Studies

West Essex Reginal High School, North Caldwell, NJ High School Diploma

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