TINA GRASSELLI-MILLER, D.C.

Highly motivated professional with experience in research, recruitment and clinical patient care. Possess knowledge of medical terminology coupled with a strong science background in administrative, education and clinical environments. Work well as part of a team or independently to accomplish goals and objectives.

•Passionate about Service

•Patient Education

•Excellent Communication Skills

•Work Well Under Pressure

•High Ethical Standards

•Patient/Family Care Objective

•Recruitment/Enrollment

•Detail-Oriented

•Strong Interpersonal Skills

WORK EXPERIENCE

Clinical Affairs Admin., Georgetown Univ. Lombardi Cancer Center (1996)

Lab Manager/Teachers Assistant Biological Sciences, Holy Names University, Oakland, CA (8/2000-12/2001)

Synexus Clinical Research/PPD/Thermo Fisher Scientific 12/2021-Present

Site Manager

· Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counselling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.

Manages site activities to ensure delivery of site targets as received from senior management.

·Provides direct or indirect supervision of all clinical and administrative aspects of a clinical trial within the research site to ensure delivery of targets and quality.

·Responsible for cost efficiencies within the site and all vendor contracts for services at the site.

·Continuously oversees the schedules of site staff to ensure highest utilization of all resources.

·Evaluates and implements new operational strategies to enhance efficiencies, provide competitive advantages, and improve overall profitability of the site.

·May provide input in the feasibility process, considering both recruitment and operational concerns.

·Communicates targets to the site teams and continuously measures progress.

·Plans and prepares proactively for future studies according to new and defined strategies, embracing and implementing new TA area initiatives at the sites.

·Collaborates with site and management regarding capacity planning and back-up plans, arranging and attending meetings.

·Ensures patient recruitment activities are adequate for study requirements.

·Ensures compliance with the company quality framework, regulatory (GCO) legislation, guidelines and international standards (Global/Local COPS/SOPS).

Synexus Clinical Research/PPD/Thermo Fisher Scientific 12/2021-Present

Clinical Research Coordinator II

Work with the PI, Clinical Research Manager, sponsors, monitors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs) and others at the Institute to support several aspects of the trials. Responsibilities include the collection, compilation, documentation and analysis of clinical research data. All activities conducted in accordance with appropriate relations, the Institute’s Standard Operating Procedure (SOPs), and study specific protocols and processes.

·Interpreting medical charts and extracting accurate data from medical records/EMR

·Recruiting patients according to study specific consent and patient medical history

·Knowledge of HIPPA and other laws and regulations relating to subject/patient confidentiality and protection of their privacy rights

·Collect, record, transcribe and synthesize clinical data while paying conscientious attention to details

·Compliance with the Code of Federal Regulations and the International Conference on Harmonization’s Good Clinical Practice (GCP) Guidelines.

·Maintained Good Clinical Practice (GCP) certification and training, completed at least annually. Compliance with the International Air Transport Association (IATA) Dangerous Good Regulations, with IATA certification and training

·Certification in basic life support, conducted ECG and Phlebotomy practices

·Review and develop a familiarity with the protocol, (e.g. trial proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections)

·Site preparation and start up processes in conjunction with the PI, the sponsor, the CRO and the IRB

·Maintain effective and ongoing communication with sponsor, CRO, research participants, IRB and PI during the course of the trial Record subject’s eligibility, using protocol-specific inclusion and exclusion criteria, documenting elements of each potential participant’s eligibility or exclusion

·Schedule subject appointments in compliance with protocol, including subject tests and procedures

·Conducted the Informed Consent Process and discussions with research subjects, including answering any questions related to the trial that the coordinator is trained and/or certified to answer. Obtain appropriate signatures and dates on Informed Consent and Assent forms in the format designated by the IRB. Assure that amended consent forms are appropriately implemented according the requirements of the IRB.

·Conduct trial visit procedures, including but not limited to: vital signs, data collection surveys, electrocardiograms, spirometry and phlebotomy

·Collected data as required by the protocol. Assure timely completion of Case Report forms

·Dispense Investigational Product or device according to protocol requirement and under the supervision of the PI or a delegated SubI

·Maintain Investigational Product or device accountability

·Trained in regulatory procedures for each study to keep track of Delegation logs, 1572, protocol and ICF updates

·Respond to sponsor or CRO queries

·Draft regulatory, adverse event, and protocol deviation IRB submissions for review by PI

·Complete study-specific logs

·Collect, process, and ship lab specimens

South Denver Gastroenterology, Englewood, CO 7/2020-12/2020

Clinical Research Coordinator

Work with the PI, Clinical Research Manager, sponsors, monitors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs) and others at the Institute to support several aspects of the trials. Responsibilities include the collection, compilation, documentation and analysis of clinical research data. All activities conducted in accordance with appropriate relations, the Institute’s Standard Operating Procedure (SOPs), and study specific protocols and processes.

·Interpreting medical charts and extracting accurate data from medical records/EMR

·Recruiting patients according to study specific consent and patient medical history

·Knowledge of HIPPA and other laws and regulations relating to subject/patient confidentiality and protection of their privacy rights

·Collect, record, transcribe and synthesize clinical data while paying conscientious attention to details

·Compliance with the Code of Federal Regulations and the International Conference on Harmonization’s Good Clinical Practice (GCP) Guidelines.

·Maintained Good Clinical Practice (GCP) certification and training, completed at least annually. Compliance with the International Air Transport Association (IATA) Dangerous Good Regulations, with IATA certification and training

·Certification in basic life support, conducted ECG and Phlebotomy practices

·Review and develop a familiarity with the protocol, (e.g. trial proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections)

·Site preparation and start up processes in conjunction with the PI, the sponsor, the CRO and the IRB

·Maintain effective and ongoing communication with sponsor, CRO, research participants, IRB and PI during the course of the trial Record subject’s eligibility, using protocol-specific inclusion and exclusion criteria, documenting elements of each potential participant’s eligibility or exclusion

·Schedule subject appointments in compliance with protocol, including subject tests and procedures

·Conducted the Informed Consent Process and discussions with research subjects, including answering any questions related to the trial that the coordinator is trained and/or certified to answer. Obtain appropriate signatures and dates on Informed Consent and Assent forms in the format designated by the IRB. Assure that amended consent forms are appropriately implemented according the requirements of the IRB.

·Conduct trial visit procedures, including but not limited to: vital signs, data collection surveys, electrocardiograms, spirometry and phlebotomy

·Collected data as required by the protocol. Assure timely completion of Case Report forms

·Dispense Investigational Product or device according to protocol requirement and under the supervision of the PI or a delegated SubI

·Maintain Investigational Product or device accountability

·Trained in regulatory procedures for each study to keep track of Delegation logs, 1572, protocol and ICF updates

·Respond to sponsor or CRO queries

·Draft regulatory, adverse event, and protocol deviation IRB submissions for review by PI

·Complete study-specific logs

·Collect, process, and ship lab specimens

WCG ThreeWire, Eden Prairie, MN 8/2018-3/2020

Clinical Research Enrollment Assistant/ Clinical Coordinator

Worked with research study team and independently to recruit patients for Ulcerative Colitis and Crohn’s studies. I was remotely trained by ThreeWire and managed with a high level of autonomy. This position required several years of experience in coordinating therefore my past experience was highly sought out.

·Organized and attention to detail

·Identify, screen and interview future subjects

·Built strong relationships with healthcare providers

·Compliance with GCP, SOP’s, IRB’s, CRO’s and HIPPA

·Knowledge of medical terminology, background of diseases and study protocols

· Acting as a ThreeWire consultant to the research team in a fast pace environment

·Remote web and phone conferencing

·Interpersonal Skills, speaking with patients over the phone and face-to-face in a clinical setting

·Knowledge of Patient Portals, EMR, chart review, and detailed outreach patient tracking

Storms Clinical Research Institute, Colorado Springs, CO 4/2014-5/2017

Clinical Research Coordinator

Work with the PI, Clinical Research Manager, sponsors, monitors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs) and others at the Institute to support several aspects of the trials. Responsibilities include the collection, compilation, documentation and analysis of clinical research data. All activities conducted in accordance with appropriate relations, the Institute’s Standard Operating Procedure (SOPs), and study specific protocols and processes.

·Interpreting medical charts and extracting accurate data from medical records/EMR

·Recruiting patients according to study specific consent and patient medical history

·Knowledge of HIPPA and other laws and regulations relating to subject/patient confidentiality and protection of their privacy rights

·Collect, record, transcribe and synthesize clinical data while paying conscientious attention to details

·Compliance with the Code of Federal Regulations and the International Conference on Harmonization’s Good Clinical Practice (GCP) Guidelines.

·Maintained Good Clinical Practice (GCP) certification and training, completed at least annually. Compliance with the International Air Transport Association (IATA) Dangerous Good Regulations, with IATA certification and training

·Certification in basic life support, conducted ECG and Phlebotomy practices

·Review and develop a familiarity with the protocol, (e.g. trial proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections)

·Site preparation and start up processes in conjunction with the PI, the sponsor, the CRO and the IRB

·Maintain effective and ongoing communication with sponsor, CRO, research participants, IRB and PI during the course of the trial Record subject’s eligibility, using protocol-specific inclusion and exclusion criteria, documenting elements of each potential participant’s eligibility or exclusion

·Schedule subject appointments in compliance with protocol, including subject tests and procedures

·Conducted the Informed Consent Process and discussions with research subjects, including answering any questions related to the trial that the coordinator is trained and/or certified to answer. Obtain appropriate signatures and dates on Informed Consent and Assent forms in the format designated by the IRB. Assure that amended consent forms are appropriately implemented according the requirements of the IRB.

·Conduct trial visit procedures, including but not limited to: vital signs, data collection surveys, electrocardiograms, spirometry and phlebotomy

·Collected data as required by the protocol. Assure timely completion of Case Report forms

·Dispense Investigational Product or device according to protocol requirement and under the supervision of the PI or a delegated SubI

·Maintain Investigational Product or device accountability

·Trained in regulatory procedures for each study to keep track of Delegation logs, 1572, protocol and ICF updates

·Respond to sponsor or CRO queries

·Draft regulatory, adverse event, and protocol deviation IRB submissions for review by PI

·Complete study-specific logs

·Collect, process, and ship lab specimens

·Attended Investigator’s Meetings as required or requested by the PI

Children’s Hospital Colorado, Colorado Springs, CO 10/2012-4/2014

Patient Service Coordinator

Perform front line business functions in a specialty care outpatient practice setting, including scheduling/registration, patient reception/check-in, check-out/follow up visit coordination and insurance management. Data entry proficiency in Epic and Outlook systems as the primary tools for performing key functions of PSC.

•Customer Service and communication skills with patients/families, referring providers and hospital providers.

•Organize, execute and follow-up on daily workflows, practice business operations and customer interactions, both independently and with other team members.

•Wellness Committee Coordinator for NOC/ Briargate Campus.

•Personal Development Participation: Ambulatory Education Series: Quality Improvement Strategies, Evidence Based Practice with Research. Neurology Lecture Series.

Brooks Spinal Care, Tulsa, OK 8/2007-3/2008

Chiropractic Internship

Administered, processed, and analyzed radiographs (x-rays), history intake, case management reports and health education. Distributed received funds to various accounts and participated in professional affiliations. •Cross-trained other staff members and maintained patient flow to meet schedule demands.

•Efficiently organized and maintained patient information for distribution.

LCCW, Hayward, CA 7/2003-7/2007

Chiropractic Internship

Provided patient care in health center clinical setting. Conducted full physical examinations, including, vitals, ortho-neuro, abdominal/thorax, EENT and processed/analyzed films. Diagnosed and devised case management reports specific to patient needs.

•Educated patients about personal health and Chiropractic philosophy.

•Treated patients using various Chiropractic techniques specializing in Upper Cervical protocol.

•Administered Physical therapy modalities and exercise/strength techniques.

Northern California Cancer Center, Union City, CA 5/1998-6/2000

Study Coordinator/Research

Participated in a formal study following protocol evaluating the effectiveness of breast care centers (general surgery) for managing women suspected of breast cancer in county hospitals. Worked independently to recruit/screen patients and conduct pre and post-diagnosis study visits/interviews following fixed formats (History, Family History, Psychology, Personal Education, CA Treatment Education).

•Support and coordinate daily surgery clinics for patient enrollment, consent and survey.

·Medical record interpretation, inclusion/exclusion and criteria screening/matching for studies.

•Operated and managed subject database using Microsoft Office.

•Observed, tracked, and interacted with patients from initial contact to final clinical prognosis.

•Coordinated with study team at numerous hospitals to ensure adequate internal resources and resolution. •Troubleshoot any clinical study work flow issues.

•Assists Principal Investigator to assure all key persons engages in project have met data entry requirements.

EDUCATION Doctor of Chiropractic

Life Chiropractic College West, Hayward, CA (2003-2007)

Post Bach Pre-Medical Program

Holy Names University, Oakland, CA (1999-2003)

Bachelor of Arts-Political Science

Syracuse University, Syracuse, NY (1991-1995)

Accomplishments: Congressional Internship, NCAA Team Captain, Costa Rica Medical Internship, Neighborhood Watch Program, Moms Club International AVP/Charity and Fundraising

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