News

CAREERS at CONRAD

November 6, 2014

CONRAD's mission is to improve reproductive health for women around the world, with a special focus on developing countries, by developing safe, acceptable and affordable options for contraception and HIV/STI prevention. We accomplish this by:

  • Nurturing promising research in institutions worldwide
  • Engaging in preclinical research
  • Conducting clinical trials
  • Partnering with private industry to get new products on the market
  • Collaborating with other agencies, foundations, and non-governmental organizations
  • Training investigators throughout the world in preclinical and clinical research techniques

We are seeking qualified candidates to fill staff positions in Arlington, Virginia. CONRAD/EVMS has a full benefit package to include medical, dental, vision, child and dependent care and more.  EVMS is an affirmative action/equal opportunity employer of Minorities, Females, Individuals with Disabilities, and Protected Veterans and a Drug and Tobacco free workplace.

For questions or information on these positions please contact Nancy Gonyea at ngonyea@conrad.org or 703-276-3903.

For consideration, please apply online at: http://www.evms.edu/about_evms/administrative_offices/human_resources/jobs/

OPEN POSITIONS

TITLE:  Clinical Project Manager

The Clinical Project Manager is responsible for the execution of assigned clinical trials from protocol design to the final study report.  The position is responsible for coordinating all efforts of trial implementation both within CONRAD and through a wide variety of collaborators and vendors.

Key Responsibilities: Manages project teams to deliver high quality clinical trial(s); Manages and drives all aspects of the project management process from planning, execution, control and closure proactively. Responsible for creating and maintaining timelines for each project, and uses timelines to track and manage a project’s progress.  Negotiates budgets and contracts with clinical sites and central laboratories.  This position has overall responsibility for ensuring study conduct is completed in timely manner and in compliance with all regulations and SOPs.

Qualifications: Advanced degree (e.g., MPH, MSN) with 2-3 years of experience in clinical research or BS and 5 years of related experience.  Must be detailed oriented, have excellent written and verbal communication skills, interpersonal, organizational and problem-solving skills, and strong interpersonal skills to work independently and effectively with a wide variety of medical, research and administrative personnel. Knowledge of CFR and GCP/ICH requirements is required, as well as European Clinical Trial Directive knowledge is preferred.  Ability to negotiate and manage competing priorities across multiple areas. Proficient in MS Word/Excel/Project/PowerPoint. Experience working with providers of clinical and regulatory information management systems a plus.

TITLE:  Clinical Research Associate II

Key Responsibilities:    Set-up, monitor and complete Phase I-III studies.  Review studies data and facilitate the data correction process.  Maintain adequate supply at investigative sites.  Assist in the preparation of investigator meetings, writing and preparation of medical reports, and training and orientation of clinical studies monitors.  Assist in writing protocols/amendments.  Assist in the design of case record forms.

Qualifications:  minimum 4 years clinical research experience, including monitoring and a college degree, preferably in a health related field.  Willing to travel with travel approximately 50% of the job.  Strong written/verbal communication skills and people skills. Organized and detail oriented.

TITLE:  Director of Regulatory Affairs

This position in Regulatory Affairs requires the ability to provide strategic planning and to manage CONRAD’s ongoing regulatory initiatives, interacting with the Director of Clinical Research, the Medical Director, and the Director of Product Development.  This person will be the key team member in the development team supervising the conversion of CONRAD’s current paper based IND activities to the required eCTD-based submission structure using the FDA specifications as set forth in draft guidance documents. The DRA will be responsible for guiding the preparation of IND and NDA/510(k) documents in eCTD format for submission to the FDA and equivalent documents to the EU and MCC regulatory authorities.  The ideal applicant will possess strong administrative experience and organizational skills; have experience with document management and submission tracking systems; experience with interacting with outside vendors; knowledge of the FDA Electronic Submission Gateway system (ESG); and work well in a team environment.  This person would supervise the members of the Regulatory staff.

Qualifications: Excellent competency in electronic document management systems and in the use of eCTD templates, document publishing tools, eCTD publishing/validation/review tools, submission planning systems, Electronic Submission Gateway and SPL solutions, MS Office applications, and Adobe Acrobat.  Strong organizational and problem-solving skills, ability to work independently but within a team environment and establish priorities with minimal supervision, and strong knowledge of FDA Code of Federal Regulations/ International Conference on Harmonization guidelines pertaining to clinical trials registration and drug application submission.  Experience using Accenture’s Quantum data management system, a plus; effectively communicates and negotiates, both orally and in writing.

Required Experience: Bachelors degree plus 8-10 years of clinical regulatory affairs; 2 year of formatting eCTD submissions. MBA/MPH or higher degree is preferred.

TITLE:  Regulatory Affairs Specialist

The Regulatory Affairs Specialist will be responsible for assisting with the design, preparation, and compilation of documents needed for pre-IND, IND/IDE, and NDA/510(k) submissions to the FDA and equivalent documents to the EU and MCC regulatory authorities.  The ideal applicant will possess administrative experience and strong organizational skills; have experience with GCP and FDA /ICH regulatory requirements; have experience working with eCTD templates, document publishing tools, eCTD publishing/validation/review tools, regulatory SharePoint sites, and Regulatory file shares;  be willing to maintain expert knowledge of industry guidance, regulations, and trends with respect to system validation (21CFR11) and electronic submissions; be detail-oriented; and work well in a team environment.

Qualifications: Good computer skills with eCTD processing experience; strong organizational skills, ability to work independently and establish priorities with minimal supervision; good technical writing and interpersonal skills; and strong knowledge of FDA Code of Federal Regulations/ International Conference on Harmonisation guidelines pertaining to clinical trials registration and drug application submission.  Also required is competency in electronic document management systems and in the use of eCTD templates, document publishing tools, eCTD publishing/validation/review tools, submission planning systems, Electronic Submission Gateway and SPL solutions, MS Office applications, and Adobe Acrobat.

Required Experience:  B.A./B.S. degree with at least 5 years of clinical regulatory affairs experience and at least 2 year of experience in formatting eCTD submissions.

TITLE:  Research Contract Associate

The incumbent will manage and coordinate CONRAD subawards, contracts, agreements and related policies and program standard operating procedures, including assistance with grant and subaward budgets and related financial management. Assists in the establishment and continuing development and review of CONRAD contracting plans, objectives, policies and procedures including matters such as contract selection, contract negotiation, contract administration, contract terminations, etc.

Key Responsibilities: Updates and maintenance of CONRAD boilerplate contracts are needed as these requirements change per government directives or private foundation requests. Serve as a contract resource to project monitors and will provide training to new staff on CONRAD contract procedures. Assist with preparation, review and approval of contract language and budgets of CONRAD approved subawards/contracts. Negotiate with various institutions and Principal Investigators to reach mutually approved terms, budgets and justifications for the workscope to be performed.

Qualifications: Bachelor’s degree in accounting, finance, contracts or related field required. 3+ years of experience in contract administration and/or grants accounting. Experience with USAID funding awards a plus.  Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.  Ability to write routine reports and correspondence.  Ability to speak effectively before groups of customers or employees of the medical school.  For all contract negotiation, the ability to review and negotiate fringe benefit percentages, indirect cost percentages and justification of costs requested is required.  Staying current with the Federal guidelines that governs CONRAD is also necessary.

1911 North Fort Myer Drive, Suite 900, Arlington, Virginia 22209   T: (703) 524-4744 | info@conrad.org