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Clinical Research Coordinator

Location NC - Camp Lejeune

Job Code 13001

# of openings 1

The Alaka`ina Foundation Family of Companies (FOCs) is possibly looking for a Clinical Research Coordinator to provide research support administration services for our government customer at Camp Lejeune, NC.

DESCRIPTION OF RESPONSIBILITIES:

+ Responsible for coordinating the research activities of assigned IRB-approved study protocols. Work is evaluated by observation and outcomes for effectiveness of operations and compliance with medical requirements and professional standards in terms of quality and appropriateness. Independent judgment is exercised to determine appropriate action and priorities in the performance of duties.

+ Provide support to CIDH and Primary Investigators (PI) of each protocol in accordance with written federal, Department of Defense (DoD), the Defense Health Agency (DHA), Department of the Navy (DoN), Bureau of Medicine and Surgery (BUMED), and NMCCL regulations, policies, and procedures.

+ Primarily responsible for consultation, reporting, exchange of information, orientation, teaching, support for the performance of duties, and to guide patients through a research protocol, maintaining and document contact with study subjects and research personnel from government agencies, granting agencies, industry sponsors, etc.

+ Review new research protocols for consistency, completeness, and compliance with all DoD, BUMED, NMCCL, and other federal and applicable state regulations and guidelines prior to IRB review.

+ Works closely with the Research Program Specialist (RPS) to compile the list of and order the required study materials, equipment, and supplies as specified in the research protocol.

+ Recruit, screen and consent patients using protocol inclusion/exclusion criteria, and refer eligible patients to the PI for final evaluation, as dictated by the IRB-approved protocol.

+ Provide education to patients on compliance, possible side effects, drug interactions, and the importance of contacting the coordinator for any possible adverse events.

+ Coordinate the performance of phlebotomies, electrocardiograms, intravenous infusions, vital signs, specimen collection, MRIs, and other procedures as required by the protocol.

+ Ensure that the consent process has taken place effectively and all questions are answered satisfactorily and documented.

+ Process and prepare specimens for lab analysis and shipping.

+ Assists with amendment creation and review, reporting protocol deviations or violations, reporting Serious Adverse Events and UPIRTSO, submitting continuing review documents, and final reports. Prepare reports and other correspondence regarding the research protocol for the IRB, granting agencies, industry sponsors and other organizations as required by regulation and/or the protocol.

+ Work will mainly be performed in ambulatory care spaces inpatient wards, and outlying clinics, all of which present some risk of exposure to infectious disease, for which gloves, masks, or gowns provided by the government entity may be required for safety reasons.

+ Collect data in a timely and accurate manner and submit information to coordinating centers as required.

+ Communicate in a professional and effective manner with team members and principle investigators.

+ Maintain collaborative team relationships with peers, colleagues and customers in order to effectively contribute to the working group’s achievement of goals and help to foster a positive work environment.

+ Monitor the regulatory environment and recommend changes, as needed.

+ Ensures all studies performed are in accordance with the approved protocol and applicable regulations.

+ Maintain collaborative team relationships with peers, colleagues and customers in order to effectively contribute to the working group’s achievement of goals and help to foster a positive work environment.

+ Attend seminars, workshops and conferences in order to gain insight into new trends in human research and to learn new approaches for the application of federal regulations, particularly in an atmosphere of increasingly sophisticated technology.

+ Participates in, or presents at research‐related education sessions.

+ Works closely with the Research Program Specialist (RPS) to compile the list of required study materials, equipment, and supplies as specified in the research protocol or as required for the performance of their duties. The RPS (Government employee) will place and receive all orders.

+ Coordinate with PI to ensure all resources are available as necessary to meet research timelines.

+ Work requires concentration, periods of standing and walking on a regular basis. Must work well under pressure and be adept at prioritizing and multitasking. Must be comfortable with changing conditions and research workload.

+ Will be adept in the use of managerial skills, communication skills and leadership skills to assist the PI in the administration of complex human research protocols.

+ Report adverse events to governing agencies and sponsors as required by protocol and regulations.

+ Provide other administrative duties and assist with other projects as needed that are within the scope of work.

+ Perform other appropriate tasks as required by the IRB Chair, CIDH, or DPE.

+ Other duties as assigned by Supervisor.

REQUIRED DEGREE/EDUCATION/CERTIFICATION:

Bachelor’s degree or higher in medicine, medical research, biological science, behavioral health, health science, physiology or nursing

REQUIRED SKILLS AND EXPERIENCE:

+ A minimum of two years’ experience providing direct coordination or management of research protocols OR one year experience and a certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

+ Knowledge of complex regulations, policies and procedures concerning the conduct of clinical trials, including FDA Good Clinical Practice (GCP), International Council on Harmonization (ICH) regulations and IND/IDE requirements.

+ Knowledge of medical terminology and treatment concepts.

+ A comprehensive, intensive, practical knowledge of the entire clinical research program that includes: protocol preparation, processing for approval, and continuing review; methods of communication with investigators, with command, and with higher headquarters and outside agencies; protocol tracking and data storage; and consent form regulations.

+ Demonstrated ability to work with investigators, sponsors and multidisciplinary teams.

+ Knowledge of the administrative process of, and experience with, maintaining privacy and confidentiality of PII, PHI, and research protocols.

+ Knowledge of grammar, spelling, syntax, English composition, and scientific writing style and vocabulary.

+ Skill in using desktop and networked computer software, to include intermediate or advanced level competencies with Microsoft Windows and the Microsoft Office suite (Outlook, Word, Excel). Ability to learn and master proprietary software such as EIRB, ProIRB, PROMIS and IRBNet protocol data management software, as these programs are critical to the day-to-day operations of the IRB and CID.

+ Skill to work with situations where ethical boundaries may be blurred or may be in conflict with regulations in order to achieve a safe, ethical, and legal resolution.

+ Communicates with the CIDH and Directorate of Professional Education (DPE) on a regular basis regarding protocols and related issues to facilitate timely resolution of requests received by the IRB, CIDH, or DPE. Work collaboratively with the IRB Chair, CIDH, DPE, and Research Program Specialist Program Specialist (RPS) to facilitate ongoing development, implementation and maintenance of the human subject’s protection program.

+ Ability to communicate orally and in writing with all levels of the organization and to teach in formal and informal settings. Effective, accurate, timely, and tactful communication are essential to the proper function of the department.

REQUIRED CITIZENSHIP AND CLEARANCE:

+ Must be U.S. Citizen

+ Must pass a NACI background check and be eligible for a CAC card.

The Alaka`ina Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries. Eligible employees enjoy a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.

We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees

•EOE, including Disability/Vets” OR “Equal Opportunity Employer, including Disability/Veterans”

The Alaka`ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke`aki Technologies, Laulima Government Solutions, Kūpono Government Services, and Kapili Services, Po`okela Solutions, Kīkaha Solutions, LLC, and Pololei Solutions, LLC. Alaka`ina Foundation activities principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.

For additional information, please visit www.alakainafoundation.com

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