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Remote Trial Master File Specialist Jobs in Indiana

Admissions Specialist

Marion, IN ยท On-site +1

$18.50 - $25.50/hr

Marion, IN, Hybrid (2 Office / 3 Remote) Categories: Admissions/Recruiting/Enrollment Job Title ... Evaluate all applicant files for admission. Have proficient knowledge of all National & Global ...

Specialist, Billing

Goshen, IN ยท Remote

$17.25 - $23.25/hr

... filing the secondary payer. * Ensure all billing and collection practices are compliant with CMS ... Work from home and remote location with a stable internet connection, a quiet and dedicated ...

BIM Specialist

Kokomo, IN ยท On-site +1

$45 - $50/hr

We are seeking a detail-oriented, remote BIM Specialist to join our client, a family-owned ... Maintain organized file structures and rigorous version control of all BIM data. Qualifications: 2+ ...

Work with data conversion specialists to achieve a smooth transition of legacy data. * Train end ... Familiarity with standard UNIX/SSH and FTP commands for interface file manipulation. * Familiarity ...

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Remote Trial Master File Specialist information

What is a remote trial master file specialist?

A Remote Trial Master File (TMF) Specialist is a professional responsible for managing and maintaining the documentation and records related to clinical trials, typically for pharmaceutical or biotech companies, while working from a remote location. They ensure that all essential documents are complete, accurate, and compliant with regulatory standards such as Good Clinical Practice (GCP). Their work is crucial for supporting audits, inspections, and the overall integrity of clinical trial data.

What are the key skills and qualifications needed to thrive as a remote trial master file specialist?

To thrive as a Remote Trial Master File (TMF) Specialist, you need a strong understanding of clinical trial documentation, regulatory compliance, and quality management, often supported by a degree in life sciences or a related field. Familiarity with electronic TMF systems (eTMF), document management software, and Good Clinical Practice (GCP) guidelines is typically required. Attention to detail, organization, and effective communication are vital soft skills for managing large volumes of sensitive data and collaborating with cross-functional teams. These skills ensure clinical trial documentation is complete, audit-ready, and compliant with regulatory standards, which is critical for successful study outcomes.

What are the common challenges faced by a remote trial master file specialist, and how can they be addressed?

A Remote TMF Specialist often faces challenges related to maintaining document quality, ensuring timely updates, and coordinating with geographically dispersed teams. Managing secure data access and upholding regulatory compliance standards while working remotely can also be complex. These challenges can be addressed by implementing robust digital TMF systems, establishing clear communication protocols, and participating in regular cross-functional meetings to stay aligned with stakeholders. Staying proactive in learning about regulatory changes and utilizing collaboration tools can further help ensure smooth document management and compliance.

What is the difference between Remote Trial Master File Specialist vs Remote Clinical Data Coordinator?

AspectRemote Trial Master File SpecialistRemote Clinical Data Coordinator
CertificationsICH GCP, regulatory document managementICH GCP, data management certifications
Work EnvironmentClinical trial documentation, regulatory complianceData entry, database management
Industry UsagePharmaceutical, biotech, CROsPharmaceutical, biotech, CROs

The Remote Trial Master File Specialist primarily manages and maintains regulatory documents for clinical trials, ensuring compliance and proper filing. The Remote Clinical Data Coordinator focuses on managing clinical trial data, including data entry and validation. While both roles support clinical research, the Trial Master File Specialist emphasizes document management, whereas the Data Coordinator concentrates on data accuracy and database oversight.

What are popular job titles related to Remote Trial Master File Specialist jobs in Indiana?

For Remote Trial Master File Specialist jobs in Indiana, the most frequently searched job titles are:

What cities in Indiana are hiring for Remote Trial Master File Specialist jobs?

Cities in Indiana with the most Remote Trial Master File Specialist job openings:

Paralegal Specialist - Appellate Division (Pathways Recent Graduate)

Executive Office for U.S. Attorneys and the Office of the U.S. Attorneys

Fort Wayne, IN โ€ข On-site, Remote

$50K - $89K/yr

Full-time

Medical, Life, Retirement, PTO

Posted 4 days ago


Job description

Summary
This is an excepted service appointment under the Pathways Recent Graduates Program. This appointment is a one year career development program. At the successful completion of the program requirements, you may be eligible for non-competitive conversion to a Federal career or career-conditional appointment. For more information on the Pathways Program, please visit: https://www.opm.gov/policy-data-oversight/hiring-information/students-recent-graduates/
Learn more about this agency
Duties
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***This vacancy will close once we receive (5) applicants or on the closing date, whichever is first.***
We are currently accepting applications for a Paralegal Specialist within the Appellate Division of the Northern District of Indiana. This position can be located in Fort Wayne, Hammond or South Bend.
At the full performance level, you will support Appellate Assistant United States Attorneys (AUSA) by providing a variety of paralegal or legal work which demonstrates a practical knowledge of law, the litigation and judicial process, and applicable rules, regulations, policies and procedures. Typical work assignments will include:
  • Conduct legal research on cases and issues identified by AUSAs, utilizing statutes, case law, regulations, court rules, legal treatises, legal periodicals, and policy documents.
  • Prepare drafts on a variety of legal documents, such as pleadings, memoranda of law, trial briefs, appellate briefs, summonses, complaints, indictments, answers, motion papers, and stipulations.
  • Review and organize complex factual material and other documentary data for appellate briefing.
  • Provide advice on the most efficient method for preparing legal documents.
  • Generate tables, proofread drafts, and check citations in drafts with efficiency.
  • Develop and enter various case material into a computer database.
  • Maintain calendars and track deadlines for court filings.
  • Provides advanced case support to AUSAs by reviewing witness materials, identifying deficiencies, and coordinating needed investigative follow-up.

Responsibilities will increase and assignments will become more complex as your training and experience progress.
This position has promotion potential to the GS-11 grade level. Promotion to the next grade level is at management's discretion and is based on your demonstrated ability to perform the higher-level duties, the continuing need for the higher-level duties, and "Regulatory/Administrative" approval. Promotion to the next higher grade level is not guaranteed and no promise of promotion is implied.
Travel Required: Occasional travel may be required
Requirements
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Conditions of employment
  • You must be a United States Citizen or National.
  • Initial appointment is conditioned upon a satisfactory pre-employment adjudication. This includes fingerprint, credit and tax checks, and drug testing. Continued employment is subject to a favorable adjudication of a background investigation.
  • You must be registered for Selective Service, if applicable.
  • You must submit a transcript or proof of degree/certificate.
  • Recent Graduates serve a trial period for the entire duration of their excepted service appointment.
  • You must meet all qualification requirements upon the closing date of this announcement.

Qualifications
To be eligible for a recent graduate appointment, ALL of the following requirements must be met:
  • Recent Graduates must have obtained a qualifying associates, bachelors, master's, professional, doctorate, vocational or technical degree or certificate from a qualifying accredited educational institution within the previous 2 years unless military service interfered with a veteran's eligibility to apply during that two year time frame. Veterans meeting the above exclusion may apply within 2 years of discharge or 6 years from the date of receipt of the degree whichever comes first. (Go to http://www.ed.gov/accreditation?src=rn to verify accreditation status).
  • Recent graduates must be United States citizens or owe permanent allegiance to the United States. (Currently, natives of American Samoa, Swains Island and certain inhabitants of the Commonwealth of the Northern Mariana Islands are the only groups that owe permanent allegiance to the United States.)
  • You must successfully complete a background investigation to determine your suitability for Federal employment.
  • All recent graduates are required to sign a Pathways Recent Graduate Participant Agreement.
  • Recent Graduates serve a trial period for the entire duration of their excepted service appointment.
  • Qualification requirements as outlined below:

GS-7: To be eligible at the GS-7 level, you must meet at leastONE (1) of the following conditions, as defined below:
Specialized Experience:One full year of specialized experience equivalent to the GS-5 level. Specialized experience is defined as experience drafting a variety of legal documents and correspondence. Examples of specialized experiences may include the following: assists in the preparation and organization of documentation and evidence for production as discovery and for use in trial; compiles, organizes, and indexes evidentiary exhibits for use at hearings or trial; prepares draft list of exhibits to be offered at trial; review legal documents to extract information related to specific issues; verifying citations and statutory references contained in legal documents; and utilizing various computerized data base programs to organize extensive documents.
-OR-
Education: Successful completion of one (1) full year of progressively higher-level graduate education (18 semester hours or the number of units your school uses to describe one graduate year of academic study) in a related field (e.g., Criminal Justice, Paralegal Studies, Law) leading to a master's degree OR completed bachelor's degree with superior academic achievement. See education section for superior academic achievement definition.
-OR-
Combining Education and Experience: Combinations of successfully completed graduate education and experience may be used to meet total qualification requirements. In order to qualify based on combined education and experience, candidates must demonstrate a combination of specialized experienced and graduate-level education that equals 100% of the requirements.
GS-9: To be eligible at the GS9 level, you must meet at least ONE (1) of the following conditions, as defined below:
Specialized Experience: One full year of specialized experience equivalent to the GS-7 level. Specialized experience is defined as experience performing legal research using statutes, case law, regulations, court rules, treatises, policy documents, and electronic databases such as Westlaw and Lexis. Examples of specialized experiences may include the following: summarizing findings into memoranda, annotated references, bibliographies, and organized research packages to support appellate litigation; drafting pleadings, memoranda, briefs, motions, and other legal documents by incorporating legal references, analyzing precedents, proofreading, and citation checks for accuracy; assisting with oral-argument preparation by gathering and indexing briefs, case law, and record materials under established procedures.
-OR-
Education: One of the following types of education in a related field (e.g., Criminal Justice, Law): a Master's or equivalent graduate degree (such as an LL.B. or J.D.); OR 2 full years of progressively higher level graduate education leading to such a degree. Education at the graduate level must be in an accredited college or university and must demonstrate the knowledge, skills, and abilities necessary to perform the duties of the position.
-OR-
Combining Education and Experience: Combinations of successfully completed graduate education and experience may be used to meet total qualification requirements. In order to qualify based on a combination, graduate education must be in excess of 1 full year.
Education
All academic degrees and coursework must be completed at an institution that has obtained accreditation or pre-accreditation status from an accrediting body recognized by the U.S. Department of Education in order for it to be credited towards qualifications. For a list of schools that meet this criteria, see http://www.ed.gov
Foreign Education Note: You may use foreign education to meet qualification requirements if you send a Certificate of Foreign Equivalency in with your transcript. It is your responsibility to timely provide such evidence by submitting proof of creditability of education as evaluated by a credentialing agency with your application materials. More information may be found at http://www2.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html. All documentation must be in English or include an English translation.
Additional information
For more information on the Department of Justice and the United States Attorneys' Offices, visit http://www.justice.gov/usao/.
As needed, additional positions may be filled using this announcement.
Payment of relocation expenses will not be authorized
A relocation incentive may be considered as appropriate based on qualifications.
The Department of Justice offers a comprehensive benefits package that includes, in part, paid vacation; sick leave; holidays; life insurance; health benefits; and participation in the Federal Employees Retirement System.
Veterans' Preference: If you are entitled to Veterans' Preference, you must indicate the type of preference you are claiming by checking the appropriate box in the assessment questionnaire to indicate your preference and submit the documentation as specified in the "Required Documents" section of this announcement.
Current or Former Political Appointees: The Office of Personnel Management (OPM) must authorize employment offers made to current or former political appointees. If you are currently, or have been within the last 5 years, a political Schedule A, Schedule C or Non-Career SES employee in the Executive Branch, you must disclose this information to the HR Office. Failure to disclose this information could result in disciplinary action including removal from Federal Service.
Selective Service: If you are a male applicant born after December 31, 1959, you must certify that you have registered with the Selective Service System, or are exempt from having to do so under the Selective Service Law. See http://www.sss.gov
Reasonable Accommodation Statement: Federal Agencies must provide reasonable accommodation to applicants with disabilities, where appropriate. Applicants requiring reasonable accommodation for any part of the application and hiring process should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis.
EEO Statement/Policy: The United States government does not discriminate in employment on the basis of race, color, religion, sex, pregnancy, national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service or other non-merit factor. More information can be found here: https://www.justice.gov/jmd/media/1425556/dl?inline.
Political Appointees (Current or Former): The Office of Personnel Management (OPM) must authorize employment offers made to current or former political appointees. If you are currently, or have been within the last 5 years, a political Schedule A, Schedule C or Non-Career SES employee in the Executive Branch, you must disclose this information to the HR Office. Failure to disclose this information could result in disciplinary action including removal from Federal Service.
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Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution.
Benefits
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A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Review our benefits
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.