Chief of Research Oversight and Compliance
Clinical Research Management - Sacramento, CA

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Growing and well-respected biomedical (clinical, basic and applied) research firm has openings at Travis AFB . If you are passionate about research, and are looking for a firm that shares your passion, and provides competitive salaries with a strong benefits package, join the ClinicalRM team.

We are currently seeking a Chief of Research Oversight and Compliance for the Northern California area.

RESPONSIBILITIES:
  • Expe r tis e and experience wit h Air Force ( or military service) specific h um an cl i nica l resea r ch protocols and gu i deli n es.
  • Knowledge of and exper i ence with IR B policies regarding h um an experime n t ati o n, eme r gency protocols, and adverse e v ents.
  • Knowledge of and exper i ence with IACUC policie s regarding animal experim e nt a t ion and adverse events.
  • Knowledge of M e dica l Tre a tment F a cilit y ( M TF) Inf e ct i on Control and Employee Healt h Programs.
  • Knowledge a n d e xp er i e n ce in th e inte r p retation of F ed eral and Sta t e regulati o n s part i c ular l yregarding t he protection of h u ma n sub je ct s in biome d ical research (t o i ncl u d e w o rkin g k n ow l edge of Federal r e gu l ations for h u ma n research: 21 CFR parts 50, 56, 312, and 812; and 45 CRF 4 6 ).
  • Abilit y t o advise and coun s e l on matter s of ge n eral research c o mp l ianc e a n d e t h ic al research pract i ces.
  • Exper i en ce w it h human protection ex e m pt and no n ‐ exempt exp e riment a t ion fo r m s including research pr o p osal, informed cons e nt , HIPAA, and d e ‐ identification agreements.
  • Exper i en ce w it h F ed eral W id e Assurance, Air Force (or military service) Assurance a n d A i r For c e ( or military service) add e nd u ms.
  • Exper i en ce w it h Air Force (or military service) Individual Investigator and In s t itutional agreement docum e ntat i on process.
  • Exper i en ce i n design i ng , o p erating and imple m enting el e c tron i c I R B appli c ati o ns.
  • Abilit y t o han d le multi p le a ctivit i e s simultaneously and t o effectively prioritize tasks and responsibilities.
  • Thorough k n owledg e of 1 0 US C 980 application and manage m e n t requirements.
  • Thorough k n owledg e of in cid en t al f i nd i ng s ethical issues.
  • Exper i en ce w it h FDA Inve s t igational Device Ex e mpt i o n s and Investigational N e w Drug policies and submissions.
  • Exper i en ce w it h DoD vendor contract negotiation an d review.
  • Thorough k n owledg e of Do D, DHHS and FDA Feder a l database and s p e cim en r e p o s it ory cr e ation and manage m e n t policies.
  • Must possess discr e tion and mature j u d gm e n t as confidential info r m ation is routinely e n cou n tered.
  • Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
  • Performs light duties and other related duties as required and assigned.
MINIMUM QUALIFICATIONS:
  • A Master’s de g ree is pref e rred; the Chief, RO C shall have at a mi n imu m a BA or BS d e gre e in a biomedi c al field with a m i nim um of 3 years experi e n c e i n research administration in suppo r t of clini c al/biomedical resear c h and/or IR B experience i n a heal t h ca r e environm e n t.
  • Knowledge a n d e xp er i e n ce with el e ct r oni c I R B processes is pref e rred.
  • Exper i en ce w it h IAC U C pr o t ocol submissions and k n owledge of regulations gov e rning DoD‐ sponsored animal research.
  • Previous managerial/supervisory exper i enc e with de m o n s t ra t ed success in l eading a n d ma n a ging people is r equired. Strong leadership an d te a m buildi n g skills a n d experi e nc e w o rkin g collaboratively t o motivate others are hi g hl y essential.
  • Must have and maintain a Certified IR B Professional (CI P) or Certif i ed I R B Man a ge r (C I M) ce r tificate upon meet i ng elig i bilit y cr i t eria. Thi s c e rtificatio n m u st b e a valid, unrestricted, and current certif i cation . Th e con t ractor shall confi r m that th e c e rtificatio n h a s not been suspended or r e vo k e d . Thi s does not prec l ud e any Chief, ROC w h os e certi f ic a tion , al th ough originally s uspend e d or revoked, was subseq ue nt l y fully reinst a t ed. T h e con t ractor com p an y shall perform all pr i m ary and annual certif i c ation doc u m e n t verifications for th e Chief, ROC.
  • Posse s s and maintain current certificat i on in Basic Li f e Support ( B L S) . T h e cont r actor/Chief, ROC responsible fo r maintain ing t he certif i c a t ion in a cur r en t status th r o ughou t th e l i fe of t h i s con t ract.
  • Must be able to work independently following a brief period of specific technical training.
Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM’s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks.

ClinicalRM is an Affirmative Action-Equal Opportunity Employer

www.clinicalrm.com

“NorthCoast 99” Best Places to Work recipient

Clinical Research Management - 19 months ago - save job - block
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