Clinical Research Coordinator
Clinical Research Management - California

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Growing and well-respected biomedical (clinical, basic and applied) research firm has openings for a Clinical Research Coordinator at NHRC, San Diego, CA . If you are passionate about research, and are looking for a firm that shares your passion, and provides competitive salaries with a strong benefits package, join the ClinicalRM team.

RESPONSIBILITIES:
Augment the evaluation and analysis of Department of Defense healthcare utilization data among military, veteran, and dependent populations.

Clean and edit the increasingly large and complex databases through summarization, mathematical longitudinal modeling and interpretation, utilizing complex algorithms and computer programs.

Ensure that data collected are cleaned, linked to demographic data and warehoused securely.

Keep up ‐ to ‐ date contact data for multiple contact survey studies.

Develop materials for presentations, and present these findings at peer ‐ review professional and military meetings.

Maintain complete health surveillance data on these Marines comprising over 150,000 individual records.

Collect and analyze additional questionnaire ‐ based follow ‐ up data, using standardized scannable, self ‐ completed, paper ‐ and ‐ pencil health questionnaires.

Ensure that surveys are administered by study personnel to new accessions attending basic training at MCRD, San Diego.

Surveys shall be collected by Naval Health Research Center (NHRC) contractors, processed by the contractor, and entered into a current Recruit Assessment Program (RAP) database. Establish and validation of QA processes for data integrity and security.

Establish and subsequently utilize linkages of survey data with other military and medical record databases to augment data analyses of important health questions.

Support the Millennium Cohort Study operations by continuing to follow US military personnel prospectively by using postal surveys and web ‐ based/internet surveys.

Securely maintain email addresses for study subjects, and use these email addresses to send invitational emails, Memorial and Veterans Day emails, as well as other study relevant electronic communications.

Follow cohort members previously surveyed, and continue to recruit participation for a new panel of cohort members as funding allows.

Design and maintain the survey instruments, and continue to gather self ‐ reported data on demographic characteristics, medical conditions and symptoms, alcohol and smoking behaviors, diet and exercise, as well as new information on deployment ‐ related exposures.

Utilize standardized, validated instruments to capture self ‐ assessed physical and mental well ‐ being (SF ‐ 36V), mental health diagnoses (Patient Health Questionnaire), and posttraumatic stress disorder (PCL ‐ 17).

Obtain objective health and behavioral measures from additional data sources through established data use agreements including access to the MDR (Medical Data Repository), military records, and other data for the study of long ‐ term health outcomes.

Additionally, support the work of enrollment, data collection, cohort follow ‐ up, data analyses, and dissemination of findings for the Family Study (currently >10,000 spouses). Databases, cleaning, linkages and analyses described in this section will similarly be

employed for the Family Study.

Create and revise survey instruments and develop marketing strategies to enhance response and retention efforts.

Collect and analyze data from infants born to military beneficiaries that have been captured in the Department of Defense Birth and Infant Health Registry. The Registry includes data on associated medical conditions, geographic location, and demographics of the military sponsor. Birth defects and other critical health outcomes are identified by International Classification of Diseases, Version 9 (ICD9) coding of inpatient and outpatient encounters. When linked to other standard military databases, important information can be captured on vaccination, occupational, and environmental exposures that may be associated with birth defects.

Post ‐ Marketing Vaccine Safety and Effectiveness Studies: Study the impact of military relevant vaccinations received by military personnel to ensure safety and to meet Food and Drug Administration (FDA) post ‐ marketing requirements. Vaccine exposures may be as prescribed, or inadvertent such as receipt of the anthrax or smallpox vaccine in pregnancy. This work includes creating vaccine registries to identify, invite, and enroll eligible subjects. Success depends on the ability to work effectively with external DoD entities such as the Office of Assistant Secretary of Defense for Health Affairs, the US Military Vaccine Agency, as well as other federal agencies, including the Centers for Disease Control and Prevention and the Food and Drug Administration, and vaccine manufacturers. Tasks include subject tracking, survey creation and administration, data management and analyses, and the writing of monthly, quarterly, and annual reports, as well as adverse event reports as needed.

DoD ‐ funded projects: Assess the short ‐ term and long ‐ term reproductive health effects of receipt of specific vaccines among pregnant women and their live born infants. Essential tasks include securing permission to access data from DoD databases, develop code to identify pregnancies with appropriately timed vaccine exposures, identify any live born infants born to exposed women, develop code to assign outcomes, and conduct analyses. Requires the ability to work with external funding agencies and meet any reporting requirements established by these agencies.

Study the impact of vaccinations received among military beneficiaries, as well as specific health outcomes including both adverse and protective effects of the vaccinations.

Additionally, examine the effect of a combination of vaccinations on health outcomes.

This work includes creating and working with large military databases (may exceed >1 million persons). Be facile with their creation and analyses, including date interpretation

and writing.

Support a variety of other research protocols on deployment and military health by assisting with the execution of these studies from design to completion. These tasks will include, but not limited to study design; regulatory; study execution including enrollment and retention; data base development and management; complex statistical analyses; and data reporting.

Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.

Performs light duties and other related duties as required and assigned.

MINIMUM QUALIFICATIONS:
Must have at least 3 ‐ 5 years related e xp er i en c e in a research s e tting.

Must possess and ma i ntain certif i c ation t o conduct h u ma n research such as HIPAA and CITI training.

Must have proven expe r ienc e in ma n a gin g compl e x research studies involving large data s e ts including all as p e ct s of study from e n rollment t o dat a collection an d security.

Must have abilit y t o pr o v id e coordination, oversight and mana ge ment , me e t r egulatory require m e nt s for DoD human research studies. Coordinates studies suc h as setting me e ti n g s and deadlines, ens u r in g I R B r e quirem e nt s a re m e t , and delivering of r esults t o stakeholders.

Must b e proficient in wr i tte n and verbal com m unication and interpersonal skills.

Must be able to work independently following a brief period of specific technical training.

Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM’s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks.

ClinicalRM is an Affirmative Action-Equal Opportunity Employer

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