The Senior CRA is a seasoned professional with wide-ranging experience and a thorough understanding of GCP and ICH principles. The experienced Senior CRA identifies and resolves complex issues where an analysis of situations and data requires an in-depth evaluation of multiple factors. Exercising sound judgement in selecting methods and techniques and evaluating criteria for resolving issues, the Senior CRA will establish strong, positive relationships with both internal and external partners. The successful candidate contributes to the determination or development of methods and procedures at the project and company levels.
The Senior CRA may act as a CRA team lead and must be self-motivated, independent and able to work in a small team environment. The successful candidate will be a highly organized individual who can also multitask and adjust direction based on changing project/corporate priorities. Mentoring and helping train less experienced CRAs will be important. Acting as the primary point of contact for investigator sites being responsible for ensuring the clinical trial is conducted according to CFR, ICH and GCP guidelines is a must. The Senior CRA is efficient at executing monitoring and other clinical trial management activities while tracking the progress of assigned studies/projects and identifying and resolving challenges to achieve target objectives.
The CRA II/III is a self-motivated individual able to work in a small-team environment and to independently identify tasks/issues of critical importance. In this role, you will develop a thorough knowledge of GCP, ICH and CFR principles. The successful candidate will be a highly-organized individual who can multitask and adjust direction based on changing project/corporate priorities.
As the primary point of contact for investigator sites, the CRA II/III ensures the clinical trial is conducted according to appropriate guidelines and protocols. You will be responsible for the efficient execution of monitoring and other clinical trial management activities while tracking the progress of assigned studies and project. Proactively identifying potential challenges, the CRA II develops appropriate actions to resolve issues and achieve target objectives.
Remote regions open to areas in Boston, New York, Philadelphia, Pittsburgh, Chicago, St. Louis, Detroit, Milwaukee, Minneapolis, Columbus, Cleveland, and Cincinnati.
- Perform investigator site pre-study site qualification visits including collection of site regulatory documents
- Assist with site start-up activities including site contracts and budget development/negotiation, and preparation of IRB submissions (including follow through to ensure successful outcome)
- Prepare the study reference manual, including liaising with the Contract Research Organization (CRO) team (i.e., central lab, specialty labs and vendors) to ensure efficient preparation and delivery of study materials to investigator sites
- Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug
- Participate in/lead the Investigator/Initiation Meetings, ensuring the study staff conducting the study have received the proper materials, instructions and training to safely and accurately conduct the study in line with protocol requirements
- Assist in the development of study/program plans (i.e.., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.)
- Track the movement of laboratory samples and the resulting data, including the trans-shipment of samples to specialty laboratories, or movement of samples to sample-management storage.
- Manage patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions (i.e.., study-site webinars, newsletters or other potential creative solutions)
- Monitor recruitment, data quality and patient safety while on site and remotely through EDC systems and direct site communication
- Liaise with study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries
- Maintain project files including ethics committee approvals, curricula vitae of investigators and study personnel, clinical investigators brochure, protocols, case report forms instructions, consent documents, clinical-trial material shipping orders, start-up meeting attendance documentation, letters of agreement, lab reference ranges, all investigator and site correspondence, and schedules of payment
- Identify and complete follow- up of SAEs at study sites
- Assist with data listing, data coding, patient profile reviews, database lock, and site close-out activities
- Ensure appropriate and timely submission of documents to the Trial Master File
SKILLS & REQUIREMENTS:
- Bachelor’s Degree in health sciences related field, RN or related discipline required
- Sr. CRA - Minimum 4 years field-based monitoring or other relevant experience
- CRA II/II - Minimum 2-4 years field-based monitoring or other relevant experience
- Minimum 4 years field-based monitoring or other relevant experience.
- Thorough knowledge of ICHGCP guidelines
- Strong written and verbal communication ability
- Strong PC skills (MS Word, MS Excel, MS Project)
- Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred.
- Experience with Outsourced Clinical Trials required
- Ability to travel up to 65% required
- Ability to mentor and train other CRAs
Corbus is a close-knit team of over 140 employees who are high-achievers, innovative, creative and, above all else, passionate about what we do. We hire for personality as well as for skill.
You must thrive in an entrepreneurial and autonomous environment where you will succeed based on your contribution and work ethic, not on your title or rank. At Corbus we take pride in our “family” atmosphere where each person’s contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here. Positive, team-oriented people work at Corbus and are rewarded with fun perks like weekly food deliveries to our kitchen, a monthly in-house massage therapist, company-paid classes with Title Boxing, and organized company activities and outings. Additionally, Corbus offers an attractive, comprehensive benefits package.
Corbus Pharmaceuticals Holdings, Inc. (NASDQ: CRBP) is a Phase 3 clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat inflammatory and fibrotic diseases by leveraging its industry leading pipeline of endocannabinoid system-targeting drug candidates. The Company's lead product candidate, Lenabasum, is a novel, synthetic, oral, selective cannabinoid receptor type 2 (CB2) agonist designed to resolve chronic inflammation and fibrotic processes. Lenabasum is currently being evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis, and systemic lupus erythematosus.
Corbus licensed the exclusive worldwide rights to develop, manufacture and market drug candidates from more than 600 novel compounds targeting the endocannabinoid system from Jenrin Discovery LLC. The pipeline includes CRB-4001, a 2nd generation, peripherally-restricted, selective cannabinoid receptor type 1 (CB1) inverse agonist specifically designed to eliminate blood-brain barrier penetration and brain CB1 receptor occupancy that mediate the neuropsychiatric issues associated with first-generation CB1 inverse agonists. Potential indications for CRB-4001 include NASH, primary biliary cholangitis, idiopathic pulmonary fibrosis, radiation-induced pulmonary fibrosis, myocardial fibrosis after myocardial infarction and acute interstitial nephritis, among others. CRB-4001 is scheduled to enter a Phase 1 study in 2019 followed a National Institutes of Health (NIH)-funded first-in-patient Phase 2 study.
Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer