Document Support Specialist - Clinical Trials
Document Support Specialist (Clinical Trial Support)
LOCATION: The National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Prevention (DCP), Protocol Information Office (PIO)
The Document Support Specialist is an integral part of the performance-based contract held by EDJ Associates, Inc. who plays a central part in the delivery of direct services in support of the National Institutes of Health, National Cancer Institute, Division of Cancer Prevention, Protocol Information Office. This office serves as the central hub for processing hundreds of research study letters of intent (LOIs), concepts and protocols within the Division of Cancer Prevention. The Document Support Specialist is responsible for the full range of administrative and operational support needed for successful implementation of core contract tasks.
- Maintaining accurate physical and electronic document files
- Assisting in scheduling review and other PIO meetings
- Reserving and confirming availability of conference and meeting rooms
- Preparing and distributing meeting agendas and other materials
- Word processing and formatting correspondence and other documents
- Supporting the DCP Chemoprevention Consortia
- Reviewing and validating PIO-CTS and START organizational and personal data
- Performing Data Clean-up projects
- Photocopying protocol documents and other project materials
- Controlling and ordering materials and supplies inventories
- Answer phones
- Abstracting DCP NCI Community Oncology Research Program (NCORP) concepts, protocols, revisions, amendments, and other documents into DCP databases PIO-CTS also CTEP database (START).
- Supporting the DCP Chemoprevention Consortia
- Receiving and verifying the completeness of protocol related documents
- Conducting competing clinical trials review checks for all new submissions
- Classifying received protocol documents based on type of review required
- Identifying and recommending appropriate document reviewers
- Developing and delivering orientations to new reviewers
- Distributing review documents and other related materials
- Managing scheduling of and providing support for review meetings
- Communicate with reviewers regarding review due dates, status of protocol processing, and protocol updates.
- Communicate with study sites to coordinate the submission, receipt and updating of protocol submissions.
- Coordinating support for the DCP NCORP Team
- Preparing standard reports using PIO-CTS, IPAD
- Coordinating electronic storage and physical filing of documents
- Reviewing and updating PIO-CTS and START information
- Collaborating with Project Manager in preparing SOPs, required quality control plan, and monthly report.
- Drafting response letters and other correspondence for PIO review.
- Responding to inquiries within 24 hours.
- Participating in peer reviews of protocol abstraction as part of the project’s quality assurance process.
- Other duties as assigned.
QUALIFICATIONS AND REQUIREMENTS:
Education: Candidate will have a minimum of a B.A./B.S. in a Health Science field, or equivalent experience.
Certification: Candidate must complete the Society of Clinical Research Associates (SOCRA) Certified Clinical Research Professional (CCRP) certification program within ninety (90) days of their certification eligibility date.
Experience: At least two years of research study and/or clinical trials protocol development, and or processing experience are needed; oncology is a plus. Must be familiar with complex medical terminology.
Skills/Knowledge: Data entry. Document tracking and management. Have strong attention to detail. Is able to work as part of a team or independently as needed with little direction or supervision. Have the ability to quickly analyze and resolve specific problems and cope with deadlines. Good writing skills and clear speaking voice, written and spoken language required. Proficient in Microsoft Office platform, Excel, Outlook and Oracle. Proficient with the use of office equipment and computers.
Analytical, detail-oriented, flexible, and decisive. Is able to work as part of a team or independently as needed with little direction or supervision and have the ability to quickly analyze and resolve specific problems and cope with deadlines.
Other: Excellent communication and interpersonal skills, ability to handle multiple tasks. A team player. Strong team building and people skills and ability to work under pressure with limited guidance are critical.
Requires manual dexterity sufficient to operate standard office machines such as computers, photo copiers, fax machines, calculators, and telephones. Other related duties and tasks as assigned.
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