• Job Description

  Req#: 69600

  Position Objective: Provide services as a Clinical Research Advisor in support of the overall functions of the National Institute of Mental Health (NIMH) within the National Institutes of Health (NIH). Contractor will independently provide support services to satisfy the overall operational objectives of the National Institute of Mental Health (NIMH)

  Duties and Responsibilities:

  • Work collaboratively with Clinical Trials Operations and Biostatistics (CTOBB) staff, Principal Investigators (PIs), Clinical Coordinators, Government Project Officers (GPOs) and Institute Contracting Officers; advise CTOBB regarding the findings of on-site observation of activities of both the Clinical Trials Coordinating Centers and/or the Clinical sites.
  • Implement the Clinical, Research, Support, Education and Training (CREST) activities for identified research studies.
  • Collaborate with CTOBB staff to develop a non-traditional monitoring program for NIMH funded studies.
  • Conduct routine and for cause observation visits; conduct the prequalification, qualification, initiation, organization and closeout process.
  • Perform regular reviews of study data according to data review/monitoring guidelines.
  • Develop reports of observation visit funding; ensure timely submission of reports and follow-up responses/corrective action plans in response to audit findings.
  • Ascertain and recommend appropriate follow-up response to issues at clinical sites including potential deficiencies in documentation, communication and the need for additional training.
  • Advise on guidelines and standards for the conduct of clinical trials in order to ensure data quality and compliance with regulatory requirements for clinical research.
  • Provide feedback to CTOBB staff as requested on study documents including monitoring plans, manuals of procedures, protocols and informed consent forms.
  • Maintain current knowledge of FDA regulations, Good Clinical Practice (GCP), NIH policies and human subject regulations.
  • Demonstrate expertise in data management systems and remote data monitoring.
  • Provide recommendations to CTOBB in the ongoing technical decision making required to facilitate optimal progress of the trials.
  • Maintain current knowledge of regulatory monitoring literature as well as the design and implementation of scientific studies; read current literature; participating in meetings, conferences and workshops.
  • Interpret and provide recommendations on the applications of monitoring guidelines; track the effects of implementation.
  • Develop recommended SOPs/Guidelines and templates to facilitate the operational and monitoring oversight of clinical trials.
  • Serve as branch point of contact on policies, procedures, rules and regulations concerning programmatically relevant research methods and approaches.
  • Work collaboratively with Clinical Trials Operations and Biostatistics (CTOBB) staff, Principal Investigators (PIs), Clinical Coordinators, Government Project Officers (GPOs) and Institute Contracting Officers; advise CTOBB regarding the findings of on-site observation of activities of both the Clinical Trials Coordinating Centers and/or the Clinical sites. 1
  • Implement the Clinical, Research, Support, Education and Training (CREST) activities for identified research studies. 2
  • Collaborate with CTOBB staff to develop a non-traditional monitoring program for NIMH funded studies. 3
  • Conduct routine and for cause observation visits; conduct the prequalification, qualification, initiation, organization and closeout process. 4
  • Perform regular reviews of study data according to data review/monitoring guidelines. 5
  • Work products and documents related to working with staff and advising on the findings of on-site observation of activities; implementing CREST activities for identified research studies; developing a non-traditional monitoring program for NIMH funded studies. - Ad-Hoc
  • Work products and documents related to conducting observation visits; performing regular reviews of study data; developing reports on observations of visit funding; ascertaining and recommending responses to issues at clinical sites. - Ad-Hoc
  • Work products and documents related to developing recommended guidelines and standards for conduct of clinical trials; reviewing protocols and informed consent forms; performing data management and remote data monitoring. - Ad-Hoc
  • Work products and documents related to providing ongoing technical advice to facilitate optimal progress of trials; providing recommendations to scientists and researchers; designing and implementing scientific studies; participating in meetings. - Ad-Hoc
  • Work products and documents related to interpreting and providing advice on the application of monitoring guidelines; tracking effects of implementation; developing recommended SOPs, guidelines and templates. - Ad-Hoc

  Basic Qualifications:

  • Ph.D. in Neuroscience or a related discipline; three (3) years of specialized experience plus a Master’s degree is equivalent to a Ph.D.; five (5) years of specialized experience plus a Bachelor’s degree is equivalent to a Ph.D.
  • Certified Clinical Research Associate (CCRA).
  • Experience identifying, evaluating, and establishing clinical trial sites.
  • Experience training clinical trial site staff.
  • Minimum of nine (9) years of experience conducting and monitoring clinical research studies.
  • Skilled in Microsoft Office Suite.

  Minimum Qualifications:

  • Ability to multi-task and pay close attention to detail.
  • Excellent analytical, organizational and time management skills.
  • Strong communication skills, both oral and written.

  *This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job us at recruiting@gapsi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

  GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.

  This position is contingent upon contract award.

• About the company

  GAP Solutions, Inc. is a mission support solutions provider who partners with federal civilian and defense agencies to provide full spectrum professional and specialized consulting services. Established in 1999, GAP Solutions has experienced years o...

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