Consulting Hot Jobs
Welcome to our customized job portal for our existing and new experts. These roles are hot and fresh opportunities and are updated weekly. You have the first opportunity to view these exciting roles. We want to make this information center a regular part of your career planning as you fill your schedule with new work and look for exciting roles to fulfill your career goals. If you are interested, reply to the post’s contact information, including the job order number and the job title.
Email Us
Consulting Hot Jobs Listing Below
PK Expert-Protocol Development
They need a PK expert - a PK scientist who can write a protocol for pharmacokinetic study. Timelines are tight. PK expert must have April availability (100-120 hours) to complete protocol. Additional opportunities may be available to expert through client following protocol completion.
If you have an interest and would like to learn more about this role,
please reach out to: Sherr.Kollath@Advarra.com
CSV Expert - 21CFR Part 11 Consulting
This will be a remote position starting May 1st-Dec. 2023
Part Time-Approximately 30 hours
If you have an interest and would like to learn more about this role,
please reach out to: Sherr.Kollath@Advarra.com
QUALITY CONTROL LABORATORY STABILITY TESTING and VALIDATION-Onsite/Cincinnati
Client will consider full time consultants or several part-time consultants for this role.
You will support process validation, submission batches, ensuring stability for submission batches, trouble shooting, method remediation, variation in formulation and packaging.
- Audit data for method transfers between R&D site and OH site, method verifications of USP compendial methods, and validations of non-compendial test methods for accuracy according to cGMP procedures and FDA guidelines, and in compliance with method transfer/validation protocol acceptance criteria. Utilizes electronic laboratory information systems such as LIMS and Empower to review data to ensure compliance with established specifications.
- Author and review method transfer/validation protocols, reports, change controls and other technical documents. Utilizes electronic information systems such as Wisdom and TrackWise to author documents.
- Troubleshoot complex chemical and physical testing of pharmaceutical products, packaging components, finished products and stability samples.
- Recognize and report atypical and out-of-specification results, and non-routine analytical and product problems and recommends solutions, and authors the related lab event record.
- Coordinate shipment of method transfer/validation samples, impurity standards, and reference standards between R&D sites, API manufacturing sites, and third-party sites.
If you have an interest and would like to learn more about this role,
please reach out to: Sherr.Kollath@Advarra.com
Research Nurse and/or CRC- Remote
Advarra qualified is seeking consultants to serve as Clinical Research Coordinators OR Research Nurses. Responsibilities include:
· Understanding of the regulatory and protocol requirements of the site and study.
· Lead and participate in the informed consent process to enable and ensure proper execution and enrollment of patients.
· Collect and enter data into study case report forms and/or electronic data capture system and respond to queries in a timely manner.
· Review and maintenance of Electronic Medical Records (EMR), ensuring that the information is up to date and accurate.
· Coordinates all aspects of the study including recruitment, consent, screening, scheduling, tracking and provides study updates to study participants throughout the conduct of the study.
· Support study activation and closeout activities when requested.
· Site activation and long-term support for patient consent and data collection.
We are looking for consultants for two different locations: Vicksburg, MS and Lake Ridge VA. Although the work is remote, you may be asked to travel to the location periodically over a one year period.
Part time for a one year period.
If you have an interest and would like to learn more about this role,
please reach out to: Sherr.Kollath@Advarra.com
Research Nurse AND/OR CRC- Onsite Kansas City, Mo.
Advarra is looking for qualified consultants to serve as Clinical Research Coordinators OR Research Nurses. Responsibilities include:
· Understanding of the regulatory and protocol requirements of the site and study.
· Lead and participate in the informed consent process to enable and ensure proper execution and enrollment of patients.
· Collect and enter data into study case report forms and/or electronic data capture system and respond to queries in a timely manner.
· Review and maintenance of Electronic Medical Records (EMR), ensuring that the information is up to date and accurate.
· Coordinates all aspects of the study including recruitment, consent, screening, scheduling, tracking and provides study updates to study participants throughout the conduct of the study.
· Support study activation and closeout activities when requested.
· Site activation and long-term support for patient consent and data collection.
Part time for a one year period.
If you have an interest and would like to learn more about this role,
please reach out to: Sherr.Kollath@Advarra.com
PV Expert-Adverse Events
Advarra to provide PV expert ongoing review AE's of pediatric study. Advarra medical coding review will include review of all adverse events and serious adverse events coded in accordance with the MedDRA Coding Dictionary. No existing AEs as study is in startup. Support to be requested as needed for a period of one year.
If you have an interest and would like to learn more about this role,
please reach out to: Sherr.Kollath@Advarra.com
Regulatory IND Submission SME
Our client is seeking a Regulatory IND Support SME to submit an IND to run a Phase I trial in 10 healthy pts where they are testing the relationship between the microbiome to two oncology drugs that are already approved. They will need an IND while much of the information needed for the submission is already there, they need to organize and add.
- SME can obtain all necessary documents from the public domain.
- SME will publish the INDs in eCTD format.
- SME will write both INDs.
- Outcome: SME will author and compile two separate eCTD formatted IND’s ready for publishing to FDA.
If you are interested, please email your CV reflecting your related experience to Alexandrea.Marino@Advarra.com.
Research Data Specialist – Remote and Onsite in Greater Harrisburg, PA
Advarra is seeking a full-time Research Data Specialist. This position is hybrid (remote and onsite in the Greater Harrisburg, PA area). The Research Data Specialist responsibilities include the following:
- Ensures high-quality data management: tracking, quality assurance, and participant data entry.
- Enters study data into appropriate database(s) and generates queries for missing or incorrect data.
- Performs ongoing and concurrent review of data to ensure completeness and accuracy; addresses data entry omissions or inconsistencies and amends errors in a timely manner.
- Develops and maintains systems for controlling data flow.
Bachelor’s degree and minimum of one (1) year experience in using automated data processing techniques; experience using data base software programs. Medical terminology; components of medical record preferred. CCRC/CCRP/SOCRA certification or equivalent certifications preferred. Current training in human subjects protection education, Good Clinical Practice, and HIPAA Privacy. This is a full-time hybrid role with remote work for 3 days and onsite work for 2 days in the Greater Harrisburg, PA area for 6 months.
If you are interested in this role, please email monica.bounds@advarra.com.
Regulatory Coordinator
Our Client is seeking a Regulatory Coordinator (Study Start-Up). The Regulatory Coordinator responsibilities include the following:
- Assesses analytically and implement regulatory requirements, policies, and guidance documents necessary to protect research participants’ welfare and safety.
- Ensures compliance with Good Clinical Research Practice standards
- Coordinates the review of protocols, amendments, continuing reviews, and reportable events by the Institutional Review Board (IRB) from study activation to study closure.
- Assists in drafting regulatory responses to the IRB, study sponsors, auditors, etc.; explain and interpret complex policies, regulations, statutes, and guidelines. (Detailed knowledge of DHHS, OHRP, and FDA regulatory requirements related to clinical research.)
- Gathers required documentation for internal/external audits.
- Prepares and submits various reports to sponsors, investigators, regulatory authorities, and other, as appropriate.
Bachelor’s or Master’s degree. Experience with the use of an electronic regulatory filing system preferred. CCRC/CCRP/SOCRA certification or equivalent certifications preferred. Current training in human subjects protection education, Good Clinical Practice, and HIPAA Privacy. This is a full-time remote role for 6 months. If you are interested in this role, please email monica.bounds@advarra.com.
Vendor Selection SME Consultant
Advarra is seeking a Vendor Selection SME Consultant for a time sensitive project to support our client to shape/design a full RFP process and vendor selection for their eTMF/data management system, needs to be future ready for inspection readiness.
If you are interested, please email your CV reflecting your related experience to Alexandrea.Marino@Advarra.com.
Biostatistician
Duration of Assignment: 6 months (24 weeks), Starting March/April timeframe
Number of Hours per Week: 4-8 hours (sliding scale)
Location: Remote
Description:
- Statistical analysis for device development program in all phases of development.
- Provide statistical input to study protocols
- .Write statistical analysis plans.
- Interpret study results and provide review of statistical summary reports of study results for accuracy.
If you have an interest and would like to learn more about this role,
please reach out to: Sherr.Kollath@Advarra.com
Data Manager(s)- 30-40 hours per week
Our Client is seeking an experienced Clinical Data Manager to support their expanding portfolio of clinical trial studies. They are looking for candidates who have developed and executed the full scope of GCP data management processes to support translational research as well as IDE studies.
Qualifications
● Strong understanding of GCPs, ICH, and knowledge of regulatory requirements
● Familiarity with pharma clinical trials and drug R&D process is a must.
● Programming proficiency in Python, SAS.
● Experience with database locks and data management plans
● Solid organizational and business assessment skills is required
Key Responsibilities
● Support ongoing allocated studies with data operations.
● Develops Data Transfer Agreements (data deliverables, format and timelines) for studies and serves as the main point of contact for internal and pharma teams on data deliverables.
● Various other duties
If you have an interest and would like to learn more about this role,
please reach out to: Sherr.Kollath@Advarra.com
