SUMMARY:

A detailed oriented professional with extensive knowledge of healthcare, operations, primary and specialist care and clinical research. A vast experience within clinical research industry; provides excellent organization, problem solving, troubleshooting and communication skills. Developed and proved abilities in project management, operations, team building, multiply tasking and accomplishing timelines. Excellent knowledge of clinical trial documentation, CFR Title 21, ICH GCP guidelines and TMF structure and purpose. Excellent organizational skills, able take initiative and work well under pressure to tight deadlines

RELEVANT SKILLS:

Various commercial/organizational databases, FirstDoc, Phlexview, Radar, eScan, eIndex, Captiva, CCC, Microsoft outlook, Care Web, Microsoft word, Microsoft access, Microsoft excel, Power - point, Microsoft works, Lotus Notes, BICS, Kronos, IDX, Onestaff, Epicare, Cadence, POLR, Global view, Sharp Owl, Global View, Omni view, HMS, AS400, PACS and Global Drive. Medical Terminology, Quicken, Adobe Acrobat, Accounttax, On-line Medical library, IDX and SNX, ICD-9 coding, various on-line clinical and administrative services.

EXPERIENCE:

Senior Document Specialist

Confidential, Malvern, PA

Responsibilities:

• Ensure that all client projects are consistently delivered to the highest quality level possible within budget to agreed targets, complying with applicable regulations, client expectations, company policies and procedures.
• Provide training and knowledge of clinical study processes and documentation.
• Carry out document processing moved to Pennsylvania to broaden my horizons within community health, clinical research and healthcare administration.
• Review of client documentation with respect to content, cross-section referencing and compliance with appropriate regulations.
• Trouble shooting location of documents and assign appropriate location of files, Reconciliation and remapping of TMF, Work to multiple clients filing structures, Responsibility for ensuring compliance with client and Confidential SOPs (Standard Operating Procedures), Processing client documentation into Confidential ’s eTMF solution.
• Preparation of documentation for Archive, in accordance with Confidential SOPs and industry standards,
• Ability to function as a Senior Document Administrator, Project Coordinator and/or Junior Project Manager, Ability to travel and work at client premises.

Business Office Manager

Confidential, Pottstown, PA

Responsibilities:

• Oversee 25 support staff members.
• Pro-actively identify areas of potential concern, create effective action plan to rectify, complete with follow up with respective directors.
• Recognize and implement change using resources at your disposal.
• Full circle plan of action (using quantification of problem, assessment of problem, action plan and assessment/quantify results.
• Actively sets goals and creates QI plans to achieve goals
• Assist in organization performance improvement hospital level.
• Be part of larger group for organizational improvement.
• Assists in strategic planning for services within the facility, identifying objectives for program growth and development in conjunction with department directors.
• Regularly assesses clinical and clerical processes to facilitate patient flow through the clinic, demonstrating effective problem solving skills.
• Make effective changes to schedule that create added coverage with current resources

Project Manager

Confidential, King of Prussia, PA

Responsibilities:

• Tracking subject register, inventory and meeting minutes on various excel spreadsheets, Assist Project Director and Sr. Clinical Trial Managers in project development.
• Manage weekly teleconferences with internal team members, CRA’s and sponsors.
• Developing, tracking reports, inventory spreadsheets and trip reports for sponsors.
• Assist team in assembly of mass mailing to Principal Investigators, Sponsors and Study Coordinators.
• Report weekly on subject status and site changes.
• Prepare team teleconferences agendas, addendums and IND safety letters for sites and sponsors.
• Assure PI regulatory documents are in compliance with OCR and sponsors.
• Site follow-up and assistance as needed.
• Assure sites have ordered and received adequate supplies for upcoming subjects’ appointments.
• Ensure that hiring is consistent with the business goals. Proactively manage candidate pools to ensure qualified candidates remain engaged in current or future opportunities with Pharmaceutical and ensure a strong positive client and candidate experience throughout the hiring life cycle, relationship management will be a critical component of this role.
• Utilize creative sourcing techniques for senior or mid-level positions including direct sourcing, internet recruiting, networking, utilization of external research, etc.
• Increase candidate flow and develop strategic sourcing solutions that will attract and acquire high quality candidates.
• Present qualified list of pre-screened candidates to hiring manager.
• Evaluate candidate backgrounds to match core competencies with key hiring requirements and assess motivational fit.
• Utilize appropriate selection techniques.
• Effectively integrate diversity into the staffing process to ensure diverse candidate slates.
• Manage the offer process for external candidates, including pre-employment screening and offer development.
• Possess a solid understanding of Pharmaceutical’s Benefits Program and its competitive advantage in the market.
• Achieve recruitment metrics against Global TA targets.

Administrative Director

Confidential, Boston, MA

Responsibilities:

• Manage overall administrative support to the electrophysiology department coordinate clinicians and patient schedules.
• Schedule staffing of various outpatient site locations
• Manage CRF workflow, electrophysiology assistance and prepare physicians monthly accruals
• Supervised patient follow-up on referral status, demographical and insurance updates.
• Management of electro physiology reports, Follow-up of patient medical records.
• Assures division productivity through cost management.
• Assist fellows with departmental functions as needed.
• Assistance within research in patient protocols.
• Triage incoming telephone calls, organize correspondence, Obtain insurance referrals.
• Approved/Denied office equipment/supply budgets, oversees various operational workflows.
• Schedule meetings, Organize office correspondences.
• Train administrative assistants, Manage EP clinical/surgical/administrative schedules.
• Maintenance of EP reports. Processed Payroll.

Clinical Supervisor

Confidential, Boston, MA

Responsibilities:

• Improved patient flow to maximize clinicians’ patient time and improved patient access.
• Assist with overall clinical patient care.
• Oversee operations within Confidential obstetrical and gynecology department, Payroll processing
• Direct supervision of eight clinical personnel and indirect supervision of 9 nursing personnel.
• Supervision of operations, Coordination of support staff work schedules, Assist in projects
• Train support staff to optimize patient flow while utilizing available systems,Monitor incoming call volume and improve average talk time.
• Act as a liaison between support staff and clinicians to resolve office disputes.
• Maintained contacted with self-pay clientele.
• Prepared performance evaluations of staff and processed. Create literature for distribution to patients within the Confidential organization.
• Maintained reports in preparation of various aspects within the organization.
• Processed clinician timesheets for compensation.
• Managed all aspects of the daily operations of the Obstetrics and Gynecological Department.
• Assures that the office is in compliance with JCAHO and DPH via developing new policies and procedures.
• Reviewed/developed overall check-in process to construct staffing accountability.
• Improved the departmental budget via minimizing insurance rejections.
• Ensure clinical trial start up activities, i.e. document translation of study documents, HA submission, and clinical supplies check up/import at project level.
• Ensure to set up proper staffing, recruitment/maintenance plan based on appropriate analysis of capability of sites selected, support the site initiation and trained staff for master file and facilitate preparation and monitor the collection of site level documents.

Operations Supervisor/Account Receivable Representative

Confidential, Boston, MA

Responsibilities:

• Designed training programs for unit coordinators and assistants.
• Developed notification system for primary care clinicians.
• Managed inpatient nursing/bed assignments.
• Monitored patient registration data accuracy.
• Triage/resolved incoming patient calls and any disputes.
• Organized on-site inventory and medical records.
• Resolve disputes between nursing and secretarial staff.
• Worked with managers of DFCI to construct a patient transfer system.
• Performed various projects in conjunctions with ambulatory practices, radiology, and surgical specialty.
• Trained representatives to identify areas of account rejections.
• Approved accounts write-offs, rejections and prepared self-pay accounts.
• Implemented litigation procedures on accounts. Issued status reports to department managers.
• Processed checks and cash adjustments for patient credits.
• Worked with managers of other financial classes to forecast projections. Scheduled and monitored staffing flow.
• Develop a departmental family room for inpatients.
• Scheduled IVF procedures and follow-up appointments.
• Assist in various gynecology examinations, Scheduled UAE with outside facility.
• Support full-life cycle recruitment needs for the business including direct sourcing techniques, consultative skills, and compensation, ensuring that every stage from the raising of the initial staff requisition to final appointment is carried out in accordance with global operating procedures and adhere to best practice principles.
• Resolve problems as required and ensured planning and set up of CRM timeline with staff for IRB submission, site contract, site initiation, patient recruitment, routine monitoring, and close out activities 6.
• Monitor on status of planned versus actual patient recruitment/timeline and implement strategies to correct deviations from proposed plan according to metrics.
• Ensure the site level compliance/adequate site management through co-monitoring visit with the CRA.
• Act as a liaison with clinical teams to identify issues and mediate resolution in a timely manner at a project level. Review study monitoring reports which monitor generated.
• Identify project and issues that will impact the successful conduct of a trial. Supervised site closeout activities, act as a mentor to new associates as assigned. Processed audits evaluate project and implement process improvement.
• Build strong relationships with the various line and functional clients to ensure the ability to influence, guide and drive the recruiting process.