Clinical researcher job description

This position will assist the Principal Investigator (PI) in planning and implementing clinical research studies as assigned.
PRINCIPAL DUTIES AND ESSENTIAL FUNCTIONS:

Responsible for assisting in the recruitment of study participants. Assesses potential patients and eligibility for inclusion in a particular protocol based on protocol requirements. Reviews all eligibility and ineligibility criteria in the patient's record. Verifies information with the physician. Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form.

Organizes strategies for recruiting study participants, and screening study participants for eligibility on the telephone, in the clinic and other settings as required.

Completes follow up with study participants in prescribed settings as required. Performs necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests,etc.

Completes record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods. Conducting a QC check of completed CRFs prior to submission for data entry; coordinating resolution of all data queries. Completing data entry as warranted.

Performs basic laboratory activities as needed

Complies with all institutional policies and government regulations pertaining to human subjects protections. Maintains regulatory binders, case report forms, source documents, and other study documents. Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board.

Reviews protocol with the clinical team and ensure clinical team is aware of their roles and responsibilities.

Maintains communication with IRB and study sponsor and takes lead in reporting adverse events, protocol deviations, safety reports, and other items as directed by regulatory guidelines.

Develops standard operating procedures in collaboration with site staff and sponsor to ensure compliance. Identifies and resolves problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor.

May disburse drugs and provide patient teaching regarding administration.

Responsible for assisting with IRB requirements for each study including meeting institutional educational requirements, submitting documents for review, adverse event reporting and annual reviews.

Initiates, participates, and/or consults in interdisciplinary meetings to formulate, evaluate, and implement appropriate study plans. Monitors enrollment and provide enrollment updates for the clinical team and the sponsors. Collaborates with professional staff both within and outside the hospital.

Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.

Organizes and participates in site visits with the study sponsor to review completeness and accuracy of study documentation.

May develop, in collaboration with the investigators and site staff, the site-specific protocol documents and informed consent document, with assistance from the sponsors.

May assist in budgeting clinical trials, grant preparation, and writing research reports and scientific papers.

May be responsible for junior staff supervision.

Rockingham County is an equal opportunity employer and will comply with federal and state statutes regarding discrimination in employment.
General Definition of Work

Performs intermediate advanced technical work providing healthcare services to the children in the County, preparing and maintaining files and records, preparing reports, and related work as apparent or assigned. Work is performed under the limited supervision of the Public Health Nursing Director II.

Qualification Requirements

To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable an individual with disabilities to perform the essential functions.

Examples of Duties

Essential Functions

Assesses children 0-21 years of age using nursing assessment skills; makes appropriate referrals to health providers as needed for medical issues that require care beyond primary care services.

Takes medical histories, maintains patient medical records, performs tests including height, weight, blood pressure and pulse readings; assesses needs of the patient.

Makes home visits to patients as needed; ensures that all medical appointments have been made during visit; verifies transportation availability.

Counsels and guides patients in proper methods of personal health care.

Educates clients as to the resources that are available, such as WIC CC4C PCM, Parents as Teachers Pregnancy Care Center, etc.

Prepares reports and other types of correspondence; prepares and maintains files and records.

Reviews State clinical data for abnormal hemoglobin status (sickle cell); maintains sick cell log.

Determines immunizations that are required; councils parents on the side effects; administers immunizations.

Assists with quarterly audits; completes audit forms; identifies deficiencies and notifies supervisor if corrections are needed.

Reviews all lead results and mails appropriate letters to clients; interprets lab results.

Attends meetings as required.

Assists support staff with client questions, concerns, needs, etc.

Knowledge, Skills and Abilities

Comprehensive knowledge of County and Department policies and procedures; comprehensive knowledge of the principles, standards, practices and techniques of professional and public health nursing; comprehensive knowledge of treatment, assessment, immunization and related medical services for the type of medically ill patients in area of assignment; thorough knowledge of local and State rules, regulations, procedures and policies pertaining to nursing services; comprehensive knowledge in preparing reports and other types of correspondence; comprehensive knowledge in the use of standard office equipment and associated software (e.g. Patagonia HER software); comprehensive knowledge of and in the use of the equipment required for the position; ability to exercise judgment in appraising situations and making decisions; ability to accurately maintain patient medical records; ability to make arithmetic computations; ability to compute rates, ratios and percentages; ability to solve problems within scope of responsibility; ability to communicate effectively in oral and written form; ability to establish and maintain effective working relationships with patients, physicians and associates.

Physical Requirements

This work requires the regular exertion of up to 10 pounds of force, frequent exertion of up to 25 pounds of force and occasional exertion of up to 50 pounds of force; work regularly requires speaking or hearing, using hands to finger, handle or feel, reaching with hands and arms, pushing or pulling and repetitive motions, frequently requires standing, walking, sitting and lifting and occasionally requires stooping, kneeling, crouching or crawling and tasting or smelling; work requires close vision, distance vision, ability to adjust focus, depth perception, color perception, night vision and peripheral vision; vocal communication is required for expressing or exchanging ideas by means of the spoken word and conveying detailed or important instructions to others accurately, loudly or quickly; hearing is required to perceive information at normal spoken word levels and to receive detailed information through oral communications and/or to make fine distinctions in sound; work requires preparing and analyzing written or computer data, visual inspection involving small defects and/or small parts, using of measuring devices, operating machines, operating motor vehicles or equipment and observing general surroundings and activities; work regularly requires exposure to fumes or airborne particles, exposure to toxic or caustic chemicals and exposure to blood borne pathogens and may be required to wear specialized personal protective equipment, frequently requires working with volatile, unpredictable patients and occasionally requires working near moving mechanical parts, exposure to outdoor weather conditions, exposure to the risk of electrical shock and wearing a self-contained breathing apparatus; work is generally in a moderately noisy location (e.g. business office, light traffic). Minimum Qualifications

Education and Experience

Associates/Technical degree with coursework in nursing, or related field and moderate experience in professional nursing including one year in a public health environment, or equivalent combination of education and experience.

Special Requirements

Possession of a valid NC Nursing license upon hire.

Completion of Title X Mandatory Reporting and Human Trafficking, Patagonia and Child Health Enhanced Role Nurse training within six months of hire.

Valid driver's license in the State of North Carolina.

Supplemental Information

Note: In accordance with State mandates and the Rockingham County Emergency Operations Plan, Rockingham County Health and Human Services staff from the Divisions of Social Services, Public Health and Integrated Health are required to staff emergency shelters during times of disaster. Please be advised that every staff person is eligible to be assigned to an emergency shelter or Emergency Operations Center.

**Everyone's unique health journey is informed by data. Join us as we translate today's discoveries into tomorrow's medicine!**

Cedars-Sinai is home to some of the most advanced biomedical research and training programs in the world, which attracts renowned physician-scientists seeking an unparalleled environment for fostering invention and teamwork.

Cedars-Sinai has been at the forefront of heart disease research and treatment for decades. Our team has played a pivotal role in establishing new cardiac subspecialties, advancing medical knowledge and developing new care techniques. Our legacy also includes sharing best practices on a global scale through leadership and publications.
To learn more about our lab and institute, please visit Smidt Heart Institute | Cedars-Sinai

**Job Summary:**

The Clinical Research Data Specialist I manages the data for assigned research studies. This will include, designing forms for data collection, clinical data abstraction, processing data, maintaining record systems, and producing project reports for studies. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.

+ ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:Manages data for research studies.

+ Designs forms for data collection.

+ Performs clinical data collection/abstraction.

+ Processes clinical data using a range of computer applications and database systems to support cleaning and management of subject or patient data.

+ Produces project reports.

+ Maintains the accuracy, integrity and security of complex, large computerized records systems.

+ Understands regulations, policies, protocols and procedures to control and maintain accurate records .

+ Performs data searches and other related administrative tasks.

+ Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.

+ Maintains research practices using Good Clinical Practice (GCP) guidelines.

+ Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

+ Participates in required training and education programs.

Education and Experience:

+ Minimum of a Bachelor of Science or Bachelor of Arts degree required

+ One (1) year of experience in related field, preferred.

+ Experience with coding R, STATA, SAS, SQL, or comparable software to manage and analyze large datasets highly desired

+ Prior training or experience in statistics is preferred.

**Working Title:** Clinical Research Data Spec I/S Cheng

**Department:** Heart Institute Operations

**Business Entity:** Academic / Research

**Job Category:** ,Information Technology,Information Technology

**Job Specialty:** Business Systems & System Analysis

**Position Type:** Full-time

**Shift Length:** 8 hour shift

**Shift Type:** Day

Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.