US-MA, Clinical Research Associate (Ophthalmology) KBM12595-MZ
Seeking an exciting leadership position in the clinical arena? Looking to truly impact patient care? I have a wonderful opportunity for a Clinical Research Associate (emphasis in ophthalmology therapeutics, drug and medical device) within a highly regarded sponsor organization with a candidate like you in mind.
The current role requires a dynamic, motivated and experienced individual and offers a competitive salary with an impressive benefits package.
· Ability to critically evaluate clinical data ensuring investigator and site compliance with the study drug protocol, overall clinical objectives, FDA regulations (CFR), ICH/GCP Guidelines and HIPAA
· Responsible for the management of designated clinical trials including investigator selection, analysis of potential patient recruitment, preparation of trial related documentation
· Perform source data verification (SDV) and assure timely completion of CRFs according to Clinical Monitoring Plan (CMP) and / or Data Management Plan (DMP)
· Maintain thorough reporting and tracking of site visits according to company SOPs
· Planning the requirements for clinical trial material, ordering clinical trial material (head office or local comparators), setting up and monitoring the systems whereby the Clinical Research Assistant can ship CT material to the investigator, maintaining procedures to account for the CT material, checking the expiration of CT material and requesting extensions if necessary
· Assure proper site data management protocols including the expedient documentation of serious adverse events (SAE)
· Review all case report forms (CRF) and compare to source documents
· Point of first contact (POFC) for investigators/site personnel for ongoing trials
· Participate in global conference calls and meetings to review progress of ongoing clinical trials.
· Manage patient recruitment strategies to increase patient randomization of trial
· Maintain project files including: ethics committee approvals, curricula vitae of investigators and study personnel, 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
· Participate in departmental planning sessions, and SOP development
· Provide management of fellow CRA’s to ensure that their role and contribution is optimized
· Provide clear communication between levels of project: from team, to site and report to overall project leaders
· Maintain current regulatory documentation according to Essential Regulatory Document Guidelines (ERDG)
· Participate in on-site audits as requested.
Requirements and Qualifications:
· BS/MS/RN degree from accredited institution (or foreign equivalent)
· Minimum of 2 years experience in ophthalmic clinical research
· Previous Clinical Monitoring and/or Site Management experience
· Effective communication skills with the ability to build strong internal and external relationships
· Team player with the ability to assume leadership role
· Travel expected; 25%
· In-house CRA experience preferred
For more information on the exciting opportunity, please contact Kevin Burns
+1 (919) 838-7478
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