Clinical Research Associate
Silver Spring, MD  / Durham, NC 
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Posted 5 days ago
Job Description
Clinical Research Associate
Location US-MD-Silver Spring | US-NC-Durham
Job ID 2020-1962
Category Research
Type Salaried Full Time Employee
Overview

SSS, a DLH Corporation company, serves federal government clients throughout the United States and abroad delivering technology enabled solutions in key health and human services programs. The Company's core competencies include secure data analytics and statistics, clinical trials and laboratory services, a full suite of public health research offerings, performance evaluation, system modernization, operational logistics and readiness, and strategic digital communications. DLH has over 2,000 employees serving numerous government agencies. DLH's portfolio consists of Defense & Veteran Health Solutions, Human Services Solutions and Public Health & Life Sciences.

 

SSS is seeking an In-House Clinical Research Associate who will be responsible for coordinating clinical research site participation in National Institutes of Health (NIH)-funded research through the management of administrative aspects of protocol development, site selection and preparation, and site implementation of clinical trials. Candidate must be comfortable working in a fast paced environment. Candidates based in our Silver Spring, MD or Durham, NC offices will be considered.

Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

    Site Liaison: Serve as the liaison between SSS internal groups, investigators and staff of clinical research sites regarding protocol implementation and site activation Track and report on site progress, work closely with site staff to resolve issues impacting site performance. Serve as clinical site point of contact for study technical assistance or other study related information as it pertains to the sites. 
  • Site Identification, Assessment and Preparedness Evaluation: Assist with site identification and assessment; coordinate all activities that support site preparedness for protocol activation, implementation, and May participate in visits to clinical research sites in order to assess the infrastructure, resources, and training needed to conduct clinical trials. In collaboration with the sponsor and other federal or contractual entities, develop plans and mechanisms for, and participate in, the evaluation of the sites' preparedness to implement clinical trials. Work with the data management center to arrange training on data and laboratory systems if sites are unfamiliar with the applications. Work with the sites and client to ensure site laboratory capabilities. Prepare reports on findings and recommendations.
  • Protocol Development and Implementation: Assist sponsor as needed with protocol development including reviewing and commenting on protocol drafts. Develop protocol-related documents including consent forms Coordinate activities associated with protocol development and implementation, including the dissemination and posting of final protocol documents, , clarification and information memos, manuals of operations, and other documents as 
  • Regulatory: Track and facilitate the regulatory document review Review site informed consents, Form FDA 1572, site delegation logs, and other documents to ensure compliance with regulatory requirements. Document and archive site requirements for clinical trial implementation.
  • Conflict and Problem Resolution: Anticipate and identify potential problems and propose preventive measures and Identify and implement measures to facilitate process improvement.
  • Training Coordination: Conduct clinical research site staff training and education in areas such as: final protocol, site establishment, regulatory preparedness, site operations and record keeping, clinical research, and good clinical Develop training and educational materials suitable to specific study and site needs. Coordinate logistics and participate in additional site training meetings and in site visits for the training of clinical research site staff.
  • Site Remedial Activities: Facilitate any needed site assistance required for remedial or corrective action required as a result of monitoring/auditing by the sponsor or other regulatory agencies or Participate as required in site assessment/site initiation visits.
  • Coordination with the Client, Consultants, and Other Contractors and Regulatory Agencies: Lead conference calls and meetings, produce summaries, and track completion of project action Serve as a representative of the project and SSS, communicating professionally and effectively with the client and all collaborators.
  • Additional duties as assigned.
Qualifications

Candidates for this position should have the following education/experience and demonstrate mastery of the following knowledge, skills, and abilities:

 

Education and Experience

  • A baccalaureate degree from an accredited college or A master's degree or equivalent is preferred.
  • Relevant experience or coursework in public health, biomedical research or other related
  • A minimum of 5 years of increasingly responsible, experience relevant to implementing clinical trials
  • Experience working with clinical trial 

Knowledge, Skills and Abilities

  • Manage a heavy workload, and multiple projects with competing priorities, switching priorities quickly as needs Must be comfortable working in quick-paced environment.
  • Demonstrate technical skill and expertise as pertains to clinical research site
  • Demonstrate exceptional interpersonal skills and written and verbal communication
  • Demonstrate decision-making abilities and problem-solving
  • Recognize which decisions may have a consequential effect on the Project and/or company and make decisions based on experience, skill, and situation, consulting with and/or informing others as

 

**** Ability to travel up to 10% if required

 

SSS is committed to fostering a diverse workforce and is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, or protected veteran status and will not be discrimated against on the basis of disability.

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DLH Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
5+ years
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