Clinical Protocol Developer

Goldbelt, Inc. • $85K — $95K *
Portsmouth, VA 23703In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Master's degree in biological or health sciences, physiology, veterinary medicine, or related field.
  • 3 years of relevant research experience.
  • Strong communication skills with stakeholders.
  • Excellent written, verbal, organizational, and interpersonal skills.

Responsibilities

  • Assist in the development and writing of research protocols for human and animal studies.
  • Support government PIs in preparing new investigator-initiated trials and regulatory compliance documentation.
  • Prepare informed consent statements and other research-related documents.
  • Conduct literature reviews and draft technical documents for review.
  • Ensure protocols adhere to DOD standards for ethics and compliance.
  • Facilitate communication with institutional review boards and committees regarding research processes.
  • Transition projects from development to operations with clinical detail integration.

Benefits

  • Medical, dental, and vision insurance.
  • 401(k) plan with company matching.
  • Tax-deferred savings options.
  • Supplementary benefits.
  • Paid time off.
  • Professional development opportunities.
Full Job Description
Summary:

The Clinical Protocol Developer shall provide technical and scientific support for the development and execution of investigator-initiated protocols and clinical trials at NMCP. This position will partner with the PI to fully develop an idea from the letter of intent (LOI) stage to an ethical and IRB/IACUC-compliant protocol that can be successfully executed at NMCP.

Responsibilities

Essential Job Functions:
  • Assist physicians/scientists in developing, writing and producing human and animal research protocols and nonhuman subjects' protocols NMCP CID and GME.
  • Assist the government PIs with the preparation of new investigator-initiated trials, coordination of the submission, submission of amendments and regulatory compliance reports, and the development of the final product (presentation and/or publication), subject to final Government approval.
  • Assist with preparing informed consent statements and other study related research documents, subject to final Government approval.
  • Conduct literature reviews and draft scientific and technical documents, subject to final Government approval.
  • Assist the with ensuring government PI-initiated protocols contain quality research design, and meet DOD standards for ethics and compliance, subject to final Government approval.
  • Assist with the amendment of existing investigator-initiated protocols, subject to final Government approval.
  • Assist the government PI with addressing Scientific Review Committee (SRC), Institutional Review Board (IRB), and other committee queries.
  • Assist the PI with Academic Research Competition (ARC) queries and submissions
  • Attend and assist with the planning of committee meetings for research specific working groups to facilitate development. Contractor shall not function as a voting member.
  • Assist with administering the study development tracking system and updating protocol details and development events in eIRB system, subject to final Government approval.
  • Work with the data management team, clinical operations team and other research collaborators (as required) in transitioning projects from the development team to the operations team that incorporates the clinical details needed to treat patients and the research elements to answer study questions.
  • Assist the clinical research coordinator in the development of specimen submission. Specimen submission shall be in accordance with the Government's protocols and are in accordance with requirements and regulations for research studies and as determined by the project leaders. Specimen submission is subject to final Government approval.
  • Assist the research and statistical data coordinators, database developers and database administrators in study database development and data monitoring planning, subject to final Government approval.
  • Assist with collecting information on reported problems regarding consistency and/or clarity in open protocols.
  • Assist with initial and follow-on updates of study registration on clinicaltrials.gov, including facilitation of Quality Assurance (QA) Review comments with coordination of the PIs, subject to final Government approval.
  • Participate in the collection of data, supporting both human and animal protocols.
  • Provide education and training to researchers and staff on protocol development within and outside department. Contractor shall not provide education and training to Government or military personnel without prior endorsement by the COR and the cognizant local Government Staff Training Manager. All education and training materials are subject to final Government approval.

Qualifications

Necessary Skills and Knowledge:
  • Ability to communicate effectively with senior Government, clinical, scientific, contracting, and research stakeholders.
  • Excellent scientific, technical, written, verbal, organizational, and interpersonal communication skills.

Minimum Qualifications:
  • Masters degree in a biological, health science, physiology ,veterinary medicine, or related field and 3 years of relevant research experience.

Pay and Benefits

The annual salary range for this position is $85,000 to $95,000.

At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.

About Goldbelt, Inc.

Goldbelt, Inc. Careers

Joining Goldbelt, Inc. presents a prime opportunity to be part of a team that values innovation, leadership, and diversity. As a recognized leader in providing innovative solutions, Goldbelt, Inc. offers a variety of job opportunities that cater to professionals seeking growth and development in their careers.

Explore Career Opportunities

Goldbelt, Inc. is actively hiring and offers a range of positions that suit different skills and career aspirations. From internships that provide real-world experience to full-time positions that challenge and expand professional capabilities, Goldbelt, Inc. ensures that every team member can find a path that suits their career goals.

Professional Growth and Development

Goldbelt, Inc. is committed to the professional growth of its employees. With comprehensive training programs and leadership development opportunities, employees are equipped to take on leadership roles within the company. The emphasis on continuous learning and development ensures that every employee has the tools needed to succeed and innovate within their field.

Diversity and Inclusion

At Goldbelt, Inc., diversity is more than just a buzzword. The company fosters an inclusive culture where diverse perspectives are valued and contribute to the company's success. Diversity training programs are integral, ensuring that all team members understand and appreciate the strength that lies in differences.

Benefits and Culture

The benefits at Goldbelt, Inc. go beyond standard employment perks. Employees enjoy a supportive culture that promotes work-life balance, alongside benefits that cater to both personal and professional needs. This supportive environment ensures that employees feel valued and motivated to contribute their best work.

Networking and Career Advancement

Goldbelt, Inc. encourages networking within the industry, providing employees with numerous opportunities to connect with peers and leaders who can influence their career trajectory. These connections are vital for professional development and can lead to new opportunities within the company.

Applying for a Position

To apply for a position at Goldbelt, Inc., candidates are encouraged to submit a resume that highlights relevant experience and skills. The interview process is designed to assess not only professional qualifications but also a candidate's fit within the company culture and their potential to contribute to the team’s success.

Stay Connected with Goldbelt, Inc. Careers

Interested candidates can stay updated on new job opportunities and company news by subscribing to job alert emails. This personalized subscription keeps potential applicants informed about positions that match their skills and career interests.

Join Goldbelt, Inc.

Explore the career opportunities at Goldbelt, Inc. and discover how joining this team can enhance professional skills, foster personal growth, and provide a rewarding career path in a dynamic and supportive environment.

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Learn more about Goldbelt, Inc.
Industry
Aerospace & Defense
* Ladders Estimates

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