Clinical Advisor (TMFs)
Company: GAP Solutions Inc
Posted on: January 21, 2023
Position Objective: Provide services as a Clinical Advisor in
support of the overall functions of the Division of AIDS (DAIDS),
Office for Policy in Clinical Research Operations (OPCRO) within
the National Institute of Allergy and Infectious Diseases (NIAID).
Duties and Responsibilities:
- Assist with the development, implementation, and maintenance of
the DAIDS Trial Master Files (TMFs) to meet regulatory
- Provide support and guidance to various functional areas
supporting the DAIDS TMFs.
- Provide support of DAIDS TMF operations during eTMF
implementation, audits, and/or regulatory inspections.
- Ensure TMFs are inspection ready at all times and TMF documents
are filed contemporaneously in a timely manner.
- Monitor and identify study trends, communicate issues, and
escalate concerns to the federal client.
- Liaise with various functional area leads to reconcile TMF
documents which have been received to ensure completeness and
quality of files.
- Ensure compliance with ICH, U.S. federal regulations, and DAIDS
policies and procedures.
- Assist in the tracking of all TMF activities (essential
document submission and status).
- Participate in working groups and team meetings, as
- Develop SOPs as required to ensure oversight of the DAIDS TMF
- Provide guidance and consultation on regulations, policies and
procedures to DAIDS staff and collaborators. Basic
- Minimum of a MS/MA in natural sciences.
- At least 3-5 years of experience in positions of increasing
responsibility in clinical operations, TMF or essential documents
- Solid understanding of global ICH GCP requirements, including
the recent updates.
- Solid understanding of trial master files organization,
implementation and archival including other relevant regulations
and guidance to assure quality of TMFs.
- Ability to anticipate and resolve problems effectively,
experience implementing TMFs. Minimum Qualifications:
- Prior regulatory inspection experience a plus.
- Good written and oral communication skills.
- Strong interpersonal capabilities and ability to build and
- Strong verbal communication and technical writing skills .
- Ability to communicate effectively, orally and in writing, with
non-technical and technical staff.
- Detail-oriented and possess strong organizational skills with
the ability to prioritize multiple tasks and projects. *This job
description is not designed to cover or contain a comprehensive
listing of activities, duties or responsibilities that are required
by this position. To perform this job successfully, an individual
must be able to perform each essential duty satisfactorily. The
requirements listed above are representative of the knowledge,
skill, and/or ability required. Reasonable accommodations may be
made to enable individuals with disabilities to perform the
essential functions. GAP Solutions provides reasonable
accommodations to qualified individuals with disabilities. If you
need an accommodation to apply for a job, email us at
email@example.com . You will need to reference the requisition
number of the position in which you are interested. Your message
will be routed to the appropriate recruiter who will assist you.
Please note, this email address is only to be used for those
individuals who need an accommodation to apply for a job. Emails
for any other reason or those that do not include a requisition
number will not be returned. GAP Solutions is an Equal
Opportunity/Affirmative Action employer. All qualified applicants
will receive consideration for employment without regard to their
race, ethnicity, ancestry, color, sex, religion, creed, age,
national origin, citizenship status, disability, medical condition,
military and veteran status, marital status, sexual orientation or
perceived sexual orientation, gender, gender identity, and gender
expression, familial status, political affiliation, genetic
information, or any other legally protected status or
characteristics. This position is contingent upon contract award.
Requisition ID: 5631
Keywords: GAP Solutions Inc, Rockville , Clinical Advisor (TMFs), Healthcare , Rockville, Maryland
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