A Clinical Operations Specialist is responsible for planning, directing, and coordinating clinical research projects. Some of the core duties associated with the job title are listed on the Clinical Operations Specialist Resume sample as – directing the activities of workers engaged in the clinical research projects, ensuring the staff complies with protocols and overall clinical objectives; evaluating and analyzing clinical data, preparing study-related documents, instructing research staff activities, participating in preparation and management of research budgets and monetary disbursements; and participating in the development of study protocols, and advising treating physicians on appropriate dosage modifications or treatment.
Those seeking to make a career in this field should be able to demonstrate on the resume the following skills and abilities – good technical and organizational skills, a thorough knowledge of good clinical practice, the ability to establish an effective working relationship in both matrix and multicultural environment, presentation and diplomacy skills; and strong customer skills. A science degree is commonly seen on eligible resumes.
Objective : Over 3 years of cumulative experience in clinical operations, clinical development, clinical quality, and data management from the medical device pharmaceutical industry Providing operational and clinical process improvement support to senior management and clinical study teams, across all phases of the trials, in a cross functioning environment, maintaining quality and compliance.
Skills : MS Office, Management Skills, Planning.
Description :
Provided support to project managers and global study teams in managing sponsor based and CRO studies (contracts, payments, communications, FDA submissions, etc.).
Attended weekly team meetings.
Prepared and distributed meeting agenda and minutes.
Reconciled quarterly budget and provided monthly payment status of site and vendor accounts.
Worked with project managers on FAQs, site selection, site enquiries & study communications.
Processed periodic reports and other study updates for submission to senior management.
Provided logistical support to study leads, in-house and field teams - Executed daily administrative tasks related to study startup, conduct and close out activities.
Experience
2-5 Years
Level
Executive
Education
BS
Clinical Operations Specialist Resume
Headline : Responsible for Conducting monitoring and co-monitoring visits of Clinical Trial Sites to ensure adherence to US FDA Regulations, GCP Guidelines, Protocol Guidelines, Data Management Guidelines, Reviews Case Report Forms (CRFs), and supporting source documentation to ensure proper completion.
Skills : Microsoft Office, Planning, Monitoring.
Description :
Coordinated continuous quality improvement (CQI) activities for CCS.
Provided training and guidance regarding CQI.
Evaluated statistical data, programming needs, and problems throughout the company assists in the planning of the nursing orientation, nurse in-service training, and continuing education within the company, program needs, and makes recommendations for improvements.
Utilized Review of patient care to include but not limited to data collection; coordination of data and transmission of data Develops, utilizes, revises, interprets, and ensures compliance with CCS and facility policies and procedures, ACA, NCCHC, maintains professional relationships within the company.
Promoted good working relationships among nursing staff and between other disciplines and departments and with patients, and a good working relationship with Regional Managers, facility administration, CCS employees, correctional personnel, contracted providers, and outside agencies.
Evaluated and recommended methods of improving operational efficiency that is cost-effective.
Assisted in ensuring adequate staffing at institutions to meet the needs of the inmate population as well as adhering to staffing plans.
Experience
5-7 Years
Level
Executive
Education
BS
Clinical Operations Specialist Resume
Headline : Organized, resourceful and accomplished Clinical Operations Specialist professional with extensive experience in health care operations. Adept at assessing organizational challenges and creating solutions.
Skills : Highly Organized, Strong Work Ethic, Childcare Experience.
Description :
Oversaw utilization management and provide exceptional service to over 60 medical groups.
Managed denied claims through claims department management.
Handled coding and billing issues.
Collaborated with physicians' groups (IPA) on performance, practice, compliance, analytic reports, authorizations, and denial issues.
Trained clinical operations staff and providers on the utilization management processes.
Trained staff on software applications.
Managed all facility contract negotiations with Out-of-Network, medical providers requiring a Letter of Agreement (LOA) between IPA's and providers.
Experience
5-7 Years
Level
Executive
Education
BA
Clinical Operations Specialist Resume
Objective : Clinical Operations Specialist is responsible for clinical operations and quality management, ensuring safe, effective and patient-centric outcomes. This includes operational and technical aspects of the clinical care process including patient care, technical support, laboratory services, pharmacy services and clinical pharmacy services.
Skills : Medical Terminology, Medical Records, Authorizations, Hipaa, FIDA, Nurse Care Manager Assistant.
Description :
Acted as a liaison among Skilled Nursing Facilities, PCW/HHA vendors, visiting RN vendors, PT/OT vendors and Out of Network providers.
Created new authorizations and reauthorizations, reviewing procedure master, fee schedules, diagnosis tables, and modifier tables to ensure proper reporting of procedures directed by plan of care or Nurse Care Managers.
Ran report to identify members on CHHA, Hospitalization, Short/Long Term Nursing Home placements, Out Of Area, their monthly updates and monitoring.
Monitored and assigned patients home health aide (demographic updates, schedules, grievances), nursing (UAS and monthly visits), and daycare (timely attendance) services.
Screened telephone calls and helping to set up meetings for Nurse Case Managers.
Communicated to administrative management and VP's on matters related to clinical standards, patient liability, and regulatory concerns.
Coordinated and facilitated dissemination of clinical information to assure consistency of service and company standardization.
Experience
2-5 Years
Level
Junior
Education
High School Diploma
Clinical Operations Specialist Resume
Objective : Seeking a Clinical Operations Specialist position with an outstanding career opportunity that will offer a rewarding work environment along with a winning team that will fully utilize management skills.
Skills : Microsoft Office, Typing, Customer Service, Transcription, Data Entry, Shorthand, Office Equipment, Postage Equipment, Receptionist.
Description :
Highly focused and results-oriented in supporting complex, deadline-driven operations; able to identify goals and priorities and resolve issues in initial stages.
Oversaw calendars and made travel arrangements for CEO, VP, and AVP.
Prepared executive's written and electronic correspondence interfacing between business units, technology, and support teams.
Praised by supervisors for demonstrating the ability to learn new organizational processes, workflows, policies/procedures, recommended for return assignments due to solid work performance.
Exported and imported data from Oracle Primavera P6 system to excel spreadsheets.
Conducted ongoing assessments to ensure clinical and regulatory standards are met.
Coordinated and performed administrative, customer service, and clerical support tasks.
Experience
2-5 Years
Level
Executive
Education
Diploma
Clinical Operations Specialist Resume
Objective : To obtain a Clinical Operations Specialist position with a progressive organization where my previous manufacturing experience can be utilized to assist the employer in achieving its goals. I am also open to travel and relocate as needed.
Ensured the timely review and delivery of Inspection, Labeling, and Packaging records.
Tuned and troubleshoot all packaging equipment.
Performed performance evaluations.
Reviewed and revised batch records while maintaining an inventory of indirect/direct production supplies.
Experienced with oral solid dosage products, vaccines, and capsule banding.
Experienced in manufacturing, granulation, compression, encapsulation, tablet press, capsule banding, coating, and blending.
Completed documentation of all Clinical Packaging Orders and cleaning logs using GMP standards to comply with FDA, SOP, and GCP/GLP/GMP regulations accurately.
Experience
2-5 Years
Level
Executive
Education
BS
Clinical Operations Specialist Resume
Headline : Seasoned Clinical Operations Specialist professional with extensive experience in providing therapeutic and medical care services to diverse groups of individuals. Possess excellent interpersonal, time management, attention to detail, as well as written and verbal communication skills. Proven expertise in managing multiple tasks and producing high-quality time-sensitive deliverables.
Skills : Customer Service, Healthcare, Clerical.
Description :
Managed daily clinical operational outputs.
Streamlined internal business processes by enhancing patient satisfaction, provider time, and treatment room utilization.
Managed office billing system; receiving and processing payments from patients and payers as well as completing insurance verifications.
Provided support to healthcare providers with new patient onboarding, medical history documentation, appointment scheduling, and ad-hoc tasks.
Provided superior customer service to patients by anticipating their anxieties and answering questions and concerns.
Managed internal reporting system; obtaining, recording, and updating personal and financial information.
Cleaned and sanitized work areas following the proper protocols efficiently, accurately, and safely.
Experience
5-7 Years
Level
Executive
Education
BA
Clinical Operations Specialist Resume
Objective : Clinical Operations Specialist is responsible for the effective execution of the clinical operations and product development functions for the company. This includes daily clinical operations, product development, and manufacturing.
Skills : Pharmaceutical Sales, Healthcare, Customer Service, Microsoft Office, Telephone, Data Entry, Hospitals, Receptionist
Description :
Responsible for assisting the BH Manager in leading Behavioral Health Department clinical and case management programs and initiatives, including Integrated Outreach and Access for members with chronic comorbid conditions.
Assisted with the development and initiatives to establish Behavioral Health-based, Integrated medical homes and community outreach teams, and work with providers/vendors to identify referral and recruitment practices, ensuring appropriate contracting and reimbursement.
Ensured clinical programs and policies are in accordance with regulatory requirements and NCQA standards.
Responded to urgent clinical crises and complaints and provide documented resolution to the.
Developed and maintained productive relationships with the provider community across all disciplines.
Responsible for tracking and documenting their outreach attempts and preparing outreach reports for BH Manager and Director.
Played a key role in the transition of clinical operations during a large health plan acquisition.
Experience
2-5 Years
Level
Executive
Education
MS
Clinical Operations Specialist Resume
Headline : As a Clinical Operations Specialist, responsible for Assisting Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures, and relevant guidelines.
Skills : Microsoft Office, Telephonic Customer Service.
Description :
Received inbound telephone calls or paper and electronic claims from members and providers.
Resolved issues for members, providers, group administrators, and brokers.
Analyzed the situation and completes research to ensure no rework or follow-up issues.
Responsible to coordinate non-clinical case management activities.
Assisted CM in the coordination of benefits with third-party payers, request medical records from providers, maintains and updates tracking databases including but not limited to Microsoft Word, Excel, Outlook.
Prepared CM reports, documents all actions in the UM/CM mainframe applications through multiple databases as part of the Indiana Business Unit and provides administrative support.
Handled escalated and unresolved calls, issues, or correspondence and resolves complex problems requiring technical expertise, and provides quality control services.
Experience
5-7 Years
Level
Executive
Education
GED
Clinical Operations Specialist Resume
Objective : Responsible for Assisting with coordination of team meetings attends meetings and prepares accurate meeting minutes and action items, handling receipt, tracking, and disposition of Case Report Forms and Queries.
Developed, recommended, and implemented training for other staff members and has been assigned to special projects.
Conferred with project managers on office plans and utilization of space.
Completed and submitted daily, weekly, monthly and annual reports in a timely and accurate manner.
Monitored in-patient hospitalizations closely with utilization management for assigned sites.
Assisted in monitoring all sentinel events and potential catastrophic illnesses and explores/utilizes all appropriate means of limiting both CCS and contractor's liabilities.
Created and distributed newsletters, mass emails, and maintained communications regarding site acceptances, enrollments, submission of regulatory documents, protocol, amendments, etc.
Worked with vendors and the marketing department for the design and printing of study material.
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