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Clinical Research Nurse Practitioner/Physician Assistant

Employer
Medical Science & Computing (MSC), a Dovel company
Location
Bethesda, Maryland
Start date
Nov 17, 2021

View more

Discipline
Clinical, Clinical Research, Regulatory
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
BioCapital

We are currently searching for a Clinical Research Nurse Practitioner/Physician Assistant 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 Bethesda, MD.

 

Duties & Responsibilities
  • Assist the Principal Investigator in developing clinical protocols including the evaluation of feasibility and budget.
  • Manage clinical protocols by assembling and training the study team; overseeing compliance to protocol; developing and adhering to relevant SOPs; managing the quality control, completion and submission of study related documentation; preparing, submitting and maintaining IRB, FDA, and/or other regulatory documents and research correspondence.
  • Develop study budgets, and track budget expenses and billing for relevant services.
  • Monitor study enrollment goals and initiate strategies to promote enrollment and participant compliance. Coordinate and perform responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent and overseeing study visits.
  • Prepare for and coordinate site visits made by sponsors or study monitors during the course of and at the close of the study.
  • Contribute to developing educational materials and educate the community and other research professionals regarding studies and related research issues.
  • Supervise, mentor and train new or junior research staff.
  • Develop and maintain study subject databases; supervise data collection and management including the collection of source documents, using and developing CRFs, and ensuring that they are complete and accurate.
  • Execute sample collection and initial processing.
  • Supervise and coordinate the collection, processing, shipment and storage of biospecimens.
  • Manage close-out of clinical protocols including audit preparation, trial closure, and communication with regulatory agencies, assisting in the final study report and completing financial obligations.

 

Requirements
  • M.S. Degree with three plus (3+) years’ experience in addition to current Licensure and/or Certification to practice as a Physician Assistant or Nurse Practitioner in the state of Maryland.
  • NIH clinical trials experience preferred.
  • Family practice experience preferred.
  • Skilled in successful patient recruitment for various clinical studies and trials.
  • Excellent interpersonal skills.
  • Organized and detail oriented.
  • Research/clinical background a must.

 

Due to our contractual requirements and federal orders, including an Executive Order from the White House and an emergency regulation from the Centers for Medicare & Medicaid Services (CMS), the position for which you are applying requires that you provide proof of your vaccination status. If you are unable to receive the COVID-19 vaccine for medical reasons or because of a sincerely held religious belief, you may request an exemption from the vaccination requirement which shall be reviewed after the submission of requested documentation. If an accommodation is granted, the conditions may include weekly testing and masking. All Guidehouse employees also agree to follow any additional health and safety mitigation policies that may be required in the workplace.

 

 

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Company Description

Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) were acquired in October 2021.

 

Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.

 

Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

 

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance, including the Fair Chance Ordinance of Los Angeles and San Francisco.

 

If you have visited our website for information about employment opportunities or to apply for a position, and you require accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at 

 

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse, and Guidehouse will not be obligated to pay a placement fee.

 

 

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