Clinical Document Specialist Jobs

Innova Solutions is immediately hiring for a TEMP Clinical Document Specialist - Level 1 (1-2 Years)

Location: Remote- Woburn/ Cambridge, MA

Description:

Position Summary:

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 Ultragenyx's Standard Operating Procedures (SOPs) as appropriate. The Temporary 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 Ultragenyx SOPs and applicable regulations. The core duties and responsibilities of the Temporary 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
• Perform data entry and reconciliation in various clinical systems and tracking tools
• Perform QC and maintenance ofeTMF/TMF for assigned studies
• Review and classify documents collected from internal and external sources
• Create, maintain, review, and archive hardcopy TMF
• Provide direct TMF support to clinical trial activities conducted by Ultragenyx
• Follow up on quality findings
• Reconcile essential documents in both hard/soft copies to avoid duplication

Requirements:

• Familiarity with international clinical trials, clinical trial documents and document QC process highly desirable
• 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
• Good communication and interpersonal skills
• Must be able to work quickly, prioritize effectively, and show attention to detail
• Previous experience working independently and efficiently after training/onboarding
• Strong computer skills (MS Office) including exposure to data/document management systems
• Bachelor's or Associate's degree and 1-2 years of professional clinical trial experience OR a high school diploma and a minimum of 3 years of clinical support experience with essential regulatory documents

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!

PAY RANGE AND BENEFITS:

Pay Range*: $40/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.

• Advanced Tier Services partner with AWS and Gold with MS
• One of the Largest Certified MBE Companies in the NMSDC Network (2022)
• 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)

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 [email protected] 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.

The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.