Senior Clinical Research Associate
Senior Clinical Research Associate
Job Title: Senior Clinical Research Associate
Job type: Permanent or Contract
Location: Remote position
Company overview: CSA Medical, Inc. is a small medical device company located in Lexington, MA dedicated to improving the lives of those patients with Chronic Obstructive Pulmonary Disease (COPD) with Chronic Bronchitis (CB). CSA Medical has developed a breakthrough medical device, RejuvenAir®, designed to address the underlying cause of COPD, a significant unmet clinical need and the 3rd largest killer in the U.S. A successful feasibility study conducted with 35 patients in the EU has paved the way for an IDE study in the United States.
Job Summary: CSA Medical is looking for senior CRA candidates to take on the responsibilities of the RejuvenAir pivotal IDE study with a focus on site management inclusive of clinical monitoring and data collection ensuring the quality and integrity of the data in accordance with the protocol, internal SOP’s, Monitoring Plan, GCP and ICH guidelines. This person will act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. This position reports to the Director of Clinical Affairs.
- Responsible for all aspects of clinical site management
- Monitor case report forms and electronic data for quality, completeness, and accuracy
- Interact with data management and study sites to reconcile queries in a timely fashion
- Assist with the creation and collection of required study documents both internally and with the investigational study sites
- Communicates with investigators and site staff on issues related to protocol conduct, recruitment, deviations, safety, regulatory documentation, audits/inspections and overall site performance
- Assists in the training, assessment and implementation of the device and application procedure.
- Maintains data and documentation in CTMS/eTMF and other systems (as appropriate) per study timelines
- Ability to identify, assess and resolve site performance, quality, or compliance issues and escalate as necessary
- Participates in internal study team meetings as required
- Assist in the identification and qualification of study sites
- Monitor study sites (site initiation visit, interim monitoring visits and close-out visits) as needed
- Remain current on applicable scientific literature
- Other duties as assigned
- B.A. or B.S. in Biological/Health Sciences
- Minimum of 5 years of direct site management (monitoring) experience as a CRA on complex medical device trials
- CRA certification
- Must be detail oriented and have good interpersonal skills
- Pulmonary indication background is desirable
- Ability to travel domestically (approximately 50% of working time)
- Independently manage travel schedule and travel on short notice, as necessary
- Expected travel 2-3 days per week
Skills, Specialized Knowledge and Abilities:
- Must possess exceptional communication (written and verbal), interpersonal, problem solving and customer service skills
- Works successfully under tight timelines with limited supervision, effectively manages own time to ensure tasks, multiple projects are completed on time
- Ability to contribute and collaborate in a team oriented setting
- Capable of managing and prioritizing workload in a focused and efficient manner
- Computer proficiency with Microsoft Office products, Smartsheet knowledge is desirable
- Highly motivated, energetic and readily adapts to changing priorities and requirements as needed
- Excellent ability to generate and maintain accurate records
- Knowledge of ICH GCP
Please send all resumes to: firstname.lastname@example.org
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