A Distinguished Ophthalmic Research Company in Boston area is looking to hire a full time on-site or off-site Senior CRA.
Senior CRA serves as the lead in monitoring activities in accordance with established procedures. This position assists in study start up, serves as the primary contact for study sites, conducts on-site monitoring, and leads close-out activities at study sites. This position works collaboratively with cross-functional teams and independently to support the clinical trial activities.
PRIMARY RESPONSIBILITIES:
- Generates Monitoring Plans and ensures monitors adhere to the Plan and Company SOPs.
- Distributes, reviews and/or facilitates the review of monitoring reports.·
- Ensures site visits and report tracker is kept up-to-date and on schedule per the Monitoring Plan.
- Serves as a liaison between Sponsor and Monitors.
- Serves as the point of contact for Monitors in the field.
- Monitors Phase II, III and IV ophthalmic drug and device clinical trials in therapeutic areas of allergic conjunctivitis, dry eye syndrome, anti-inflammation, and anti-infective.
- Provides site support by ensuring investigational site compliance to protocol, applicable SOPs, GCPs and federal regulations by assessing protocol, GCP, and regulatory compliance of investigational research sites.
- Conducts site evaluation, initiation, interim and close-out monitoring visits as well as test article accountability and reconciliation.
- Perform complete investigational product inventory and accountability and verifies that appropriate storage, supply, usage, instruction, documentation and disposition are in place and followed.
- Ensures Adverse Events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary.
- Compares reported data with original source documents for 100% Source to CRF verification by reviewing the accuracy, completeness and timeliness of completed study related records, case report forms and other documents.
- Reviews study related processes relative to applicable regulatory requirements, including the FDA’s GCP regulations and departmental guidelines.
- Assists sites with query resolution.
- Works with sites to ensure adherence to IRB requirements.
- Provide support and timely follow-up for all audit and quality assurance activities.
- Documents and follows to resolution actionable issues requiring corrective action.
- Prepares and participates in bid defense meetings.
- Participates in meetings and in-service training activities.
- Maintains in strict confidence all confidential information regarding clinical trials and clinical research study sponsors.
- Promotes a work environment that stresses and demonstrates confidential practices.
- Facilitates communication between the investigative site and the sponsor and its representatives.
- May supervisor and mentor other CRAs at sites and in-house as needed.
- Performs related duties as required.
REQUIRED SKILLS AND ATTRIBUTES:
- Must have CCRP (certified clinical research professional)
- Strong leadership skills and the ability to lead teams and mentor other CRAs.
- Understand how to properly assess an investigative site’s capabilities for conducting clinical research.
- Ability to monitor and report on the progress of the trial from start-up to completion.
- Knowledge of how to select and qualify an investigative site.
- Capacity to routinely assessing protocol and GCP compliance.
- Demonstrated ability to verify source data to reported data.
- Strong attention to detail in order to review completeness of the investigator site file.
- Knowledge to reconcile and return/destroy test article in the course of conducting initiation, interim, and close-out visits.
- Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
- Ability to read and demonstrate a comprehension of a clinical research protocol as well as understand the importance of following the protocol.
- Demonstrate an understanding of 21 CFR sections 11, 50, 54, 56, 312, 314 and 812 and familiarity with the Nuremburg Code, the Belmont Report, the Declaration of Helsinki (1989), and the ICH guidelines governing GCPs.
- A sound knowledge of ICH and Food and Drug Administration’s Good Clinical Practices regulations.
- Attention to detail, organizational skills, interpersonal skills, and effective oral and written communication skills.
- Availability to travel up to 75% of the time.
- Bachelor’s degree in applied or life science·
- Minimum of 5 years experience in clinical trials, preferably drug trial monitoring, or equivalent training and work experience.
We offer lucrative and competitive salary along with impressive benefit package.
Qualified candidates, please fill out the online application below to apply.