Clinical Advisor, TB Research

Location
Rockville, MD, US
Posted
Apr 11, 2021
Ref
2021-9788
Hotbed
BioCapital
Required Education
Other
Position Type
Full time
Overview

We are currently searching for a Clinical Advisor, TB Research to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Rockville, MD.

Duties & Responsibilities

  • Works with Branch Chief, Physicians, and Program Officers to:
    • Review, participate in design/development, and oversee implementation of clinical trials for the treatment and/or prevention of TB and TB/HIV co-infection.
    • Evaluate the hypothesis, objectives, study design, feasibility, and regulatory requirements, as well as identifying medical and logistical problems that may impede a study.
    • Participate in clinical trial team discussion on selection and implementation of interventions, study design, evaluation of clinical events and endpoints, safety assessments, and assurance of participant safety.
    • Interact with investigators, statisticians, other program components and support contractors, product sponsors, and other agencies engaged in assigned research activities and related fields.
    • Review, assure necessary revisions, and approve drafts of trial protocol, informed consent, and important implementation documents (e.g., the Study Progress and Safety Monitoring Plan).
    • Provide subject matter expertise during protocol development leading to Program review and decision whether to approve and ensure that the concerns raised during the review are addressed by the Protocol Development Team in a timely manner to allow final approvals.
  • Monitor progress and conduct of projects, including protection and safety of participants in clinical trials.
  • Review data, progress reports, and reports of events of critical deviations from protocol or regulations, and implements corrective actions needed to achieve adequate research.
  • Advise program management of deficiencies and problems encountered during study implementation.
  • Evaluate annual IND annual reports for implementation issues and medical safety and report findings to program management.
  • Provide medical expertise in ongoing protocol follow-up stages for subject safety and protection, reliability of study endpoint data. Provide appropriate recommendations to program leadership to ensure trials are conducted according to protocol, regulations and accepted standards.
  • Provide clinical and scientific information for preparing program communications to the Food and Drug Administration (FDA), other government and nongovernmental agencies, pharmaceutical companies. and Data Safety Monitoring Boards.
  • Preview, revise (as needed) and approve safety reports (IND and MedWatch to FDA and/or safety alerts or communications for investigators), provides expert medical advice for potential impact of adverse events in ongoing research.
  • Produce documents, presentations, and responses to requests for information as required in planning and implementation of the clinical trials agenda.
  • Liaison with other NIH ICs and other sponsors to ensure coordination, avoid unnecessary duplication, and to participate in collaborative efforts being conducted nationally and internationally
  • Attend and participate in national/international scientific meetings/conferences in order to stay abreast of current research findings and to interact with other investigators to promote collaborations.


Requirements

  • RN degree and active license, PA or NP certification strongly preferred or MD degree with completed training in Internal Medicine.
  • Minimum of (3) years of extensive experience in clinical care and in conduct and oversight of clinical trials, including evaluation of safety issues, demonstrating in-depth understanding of ICH/GCP/ best practices, clinical trial regulations and requirements, ethics, and methodology; Clinical trial unit supervisory/management experience is preferred.


#LI-DD1

Company Description

We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.

The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.

What you'll get...
  • Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
  • Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
  • Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
  • Discovery! With our tuition assistance and training programs, we support your career advancement.
  • Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
  • Support! Working parents and busy professionals - we've got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
  • Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
  • A Voice! A unique culture where you can influence decisions and have your voice heard.


We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.