Clinical Documentation Specialist
American Cybersystems, Inc.

Job Info

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Innova Solutions is immediately hiring for a Clinical Documentation Specialist
Position type: Full-time Contract position 8+ months
Location: REMOTE
Pay Range: $33/hr-$38/hr

This position is responsible for collecting, reviewing, maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Standard Operating Procedures (SOPs) as appropriate. The Clinical Document Specialist will provide support to the TMF content owners on one or more clinical programs. This position will work closely with the Study Management Teams (SMT) to ensure that the TMF is kept both current and inspection ready according to SOPs and applicable regulations. The core duties and responsibilities of the Senior Clinical Document Specialist include, but are not limited to:
Responsibilities:

• Work directly with TMF Content Owners to identify issues, perform completeness checks, and upload documents to the eTMF
• Acting as TMF subject matter expert(SME)/point of contact for study teams and TMF stakeholders, including attending study team meetings and managing EDLs
• Review and classify documents collected from internal and external sources
• Reconcile essential documents to avoid duplication
• Support study teams with the TMF quality review process
• Perform QC and maintenance of eTMF for assigned studies
• Perform data entry and reconciliation in various clinical systems and tracking tools
• Provide input on revision of TMF related Work Instructions and SOPs
• Support the management and oversight of the CRO study-specific trial master files
• Support the coordination of the transfer of study-specific trial master files from the CRO
• Follow up on quality findings
• Manage paper document filing process for wet-signed documents including QC review and paper/electronic
• Participation in audit, inspection readiness preparation and inspection activities as needed
• Work cross-functionally with internal departments and external resources (e.g., CROs, Partners, etc.) to resolve gaps in the eTMF

Requirements:

• Bachelor degree or equivalent curriculum (scientific or healthcare discipline preferred) and a minimum of 2 years of professional document control experience. Persons without a formal degree who have a minimum of 4 years of training and work experience in document control and who meet job-specific criteria are eligible for
• Demonstrated experience or knowledge with sponsor or CRO clinical research process, including collection of documents at study start-up, during study conduct and close-out
• Demonstrated knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
• Familiarity with international clinical trials, clinical trial documents and document QC process highly desirable
• Experience with electronic trial master file system(s) including uploading, reviewing, quality checks (QC), approval of study required
• Working knowledge of DIA reference model
• Works under general supervision and guidance. Works with manager to establish priorities and timelines
• Strong computer skills (MS Office) including exposure to data/document management systems
• Must be able to work quickly, prioritize effectively, and show attention to detail
• Good communication and interpersonal skills
• Good time management skills, excellent attention to detail, and ability to multi-task in a high volume environment
• Team oriented and flexible; maintaining integrity and high ethical standards
• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Ability to function at a high level in a team setting whether as group contribution or acting as an individual contributor

Candidates must have good communication skills and great attention to detail.
Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.
Thank you!

Jeff.shay@innovasolutions.com

PAY RANGE AND BENEFITS:
Pay Range*: $33/hr-38/hr
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Recent Recognitions:

• One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
• ClearlyRated® Client Diamond Award Winner (2020)
• One of the Largest Certified MBE Companies in the NMSDC Network (2022)
• Advanced Tier Services partner with AWS and Gold with MS

• Website: https://www.innovasolutions.com/
  Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.

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