Clinical Research Coordinator

Job opening ID
2835

Posting title
Clinical Research Coordinator

Roles and responsibilities
Must be a US Citizen or Green Card Holder
Some travel may be required
Offer contingent on ability to successfully pass a background check and drug screen   

Columbus Technologies and Services Inc. is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Columbus offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking Clinical Research Coordinator to work onsite with the National Institutes of Health in Bethesda, MD.

This is a long-term position which offers:
- Competitive salary
- Tremendous growth opportunity
- Opportunity to work at NIH, the world's foremost medical research center
- Learn more about what Columbus can do for you at www.columbususa.com

Job Description: 
The contractor shall:

Patient Care
• Interview and screen patients for entry onto protocols.
• Work with staff on the recruitment and retention of patients into specific clinical protocols.
• Ensure protocol compliance and database management.
• Review medical records to collect relevant clinical data.
• Maintain contact with patients and referring physicians; discuss the status of patients who are participating in the study.
• Coordinate and organize the educational aspects of studies to provide optimal participation, compliance and minimal protocol deviation.
• Meet, orient and educate patients and their families; explain role.
• Schedule patients’ travel, including flight, taxi and hotel for caregivers.
• Establish and maintain relationship with research subjects.
• Respond to communications with research subjects; direct questions to appropriate team member.
• Schedule patient appointments; interact with involved departments to negotiate and expedite scheduling and completion of tests, procedures and consults.
• Develop interdisciplinary care plan by participating in meetings; coordinate information and care requirements with other members of the team; resolve issues that could affect smooth care progression; foster peer support.
• Participate in clinical meetings and patient rounds; monitor delivery of care; identify progress toward desired care outcomes; intervene to overcome deviations in the expected plan of care.
• Review care plan with patients in conjunction with the direct care providers.
• Maintain patient database by entering new information as it becomes available; verify findings and reports; back up data.
• Prepare patient charts and research binders.

Clinical Research
• Communicate and collaborate with the multidisciplinary clinical research team, including evaluators, consultants, laboratory, pharmacy and nursing staff, throughout the life cycle of the trial, to ensure appropriate patient care and timely completion of all protocol related evaluations and study drug administration.
• Work with PI to communicate study requirements to all individuals involved in the study.
• Coordinate participant tests and procedures.
• Coordinate and ensure the collection of research data and specimens are required by the research protocol.
• Enter study data in to the Electronic Data Capture (EDC) System and resolve queries (requires documented EDC training certification).
• Ensure timely completion and collection of Case Report Forms and source documents (date collection).
• Collect and ship laboratory samples to the Central Pharmacy.
• Review study drug compliance and accountability.
• Implement the standards for research protocols in compliance with regulatory, institutional and external agencies.
• Independently perform quality assurance and quality control activities to ensure ethical and high-quality research, including protocol adherence, protocol monitoring and data collection.
• Recognize and resolve significant issues; keep staff appraised of progress and/or changes in the clinical trial plan.
• Participate in training/orientation program geared to teaching or reinforcing the principles of Clinical Trials.
• Work with PIs on the protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations and agency policies and procedures.
• Establish and organize study files, including regulatory binders, study specific source documentation and other materials.

Conduct of Research
• Review and develop familiarity with protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
• Collect documents needed to initiate the study and submit to sponsor (e.g., FDA Forms 1572, CVs, etc.).
• Work with PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals.
• Obtain appropriate signatures and dates on forms; ensure that amended forms are appropriately signed and implemented.
• Maintain study timelines.
• Maintain adequate inventory  of study supplies; follow the sponsor protocol and CC policy of Investigational Drug/Device Accountability for handling investigational drugs/devices.
• Complete study documentation and maintain study files in accordance with sponsor requirements and policies and procedures, including consent forms, source documentation, narrative notes if applicable, case report forms and investigational material accountability forms.
• Retain all study records in accordance with sponsor requirements and agency policies and procedures.
• Identify and document protocol deviations.
• Maintain ongoing communication with sponsor, research participants and PI during the course of the study.
• Work with PI to manage the day to day activities of the study, including problem solving, communication and protocol management.
• Coordinate and participate in the administrative management of research protocols, to maintain regulatory documents and communications with the Institutional Review Board.
• Coordinate, facilitate and prepare site for monitoring visits and FDA audits.
• Collaborate with PI and institution staff to respond to any audit findings and implement approved recommendations.

Reporting
• Work with PI to prepare material required for IRB and FDA submissions.
• Work with PI on scientific and compliance reporting requirements in accordance with Federal regulations and agency policies and procedures.
• Work with staff on the registration (if required) of the study at ClinicalTrials.gov; maintain current information on the site.

Protected Health Information
• Adhere to and support all Federal regulations and agency policies and procedures instituted to safeguard protected health information (PHI).
• Complete all appropriate training regarding the access, use and disclosure of PHI in accordance with Federal regulations and agency policies and procedures.
• Address the compliance and monitoring efforts regarding the access and disclosure of PHI; report instances of noncompliance to appropriate compliance office.

Required Skills:
The contractor must have:
• Master’s degree in a related discipline.
• Minimum of four (4) years of experience in clinical research.
• Demonstrated strong experience with data collection.
• Excellent computer skills, including Word, Excel, PowerPoint and graphing software.
• Strong communications skills, both oral and written.
• Excellent interpersonal, analytical, organizational and time management skills.
• Ability to multitask and pay close attention to detail.


Number of positions
1

Location
Bethesda

State
Maryland