Senior Clinical Research Associate

POSITION SUMMARY:

This position will be responsible for clinical studies, site management, and compliance monitoring of assigned clinical projects undertaken in support of the Clinical Affairs portfolio.Thisposition must ensure that all activities are conducted in accordance with government regulations (FDA, MDR, and ISO) and the company’s operating procedures. Will be responsible for clinical site monitoring at study centers and may coordinate monitoring activities for other clinical research associates.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Serves as primary liaison between clinical programs and operations department for assigned study sites; collaborate with study sites and field procedural team to execute on subject recruitment goals; manage site communications and study-related activities to ensure compliance to protocol, ICH/GCP, and applicable local and regulatory authorities; accountable for data integrity, patient safety and regulatory compliance for assigned sites.
• Prepares and documents study plans, contracts, budgets, informed consents, IRB submissions, case report forms (CRFs) and other study related materials to assure quality, consistency, compliance organization, storage, and accuracy across assigned projects.
• Contributes to clinical study design, proposals, protocols, etc. Understanding basic scientific content, experimental design and analytical approaches used.
• Develops clinical monitoring plans, and assists in development of associated study documents
• Contribute to company’s clinical operating procedures related to GCP monitoring.
• Conduct site monitoring (qualification, initiation, interim monitoring and close out visits) to ensure and document site is trained to follow study procedures, is adhering to protocol, is implementing corrective actions as necessary, and is adhering to regulations and GCP for adverse event reporting.
• Assists in assuring both regulatory and clinical compliance for all assigned clinical projects; identify areas of non-compliance and ensure issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, regular site contact, analyzing study metrics, and general study data overview.
• Liaises with CROs, and works with data management, safety, biostatistics and other cross functional team members to execute on clinical trials.
• Participates in the evaluation and selection of clinical sites and relevant clinical meetings (investigator meetings, steering committee, etc.) as appropriate.
• Assists in the coordination of site contract and budget process.
• Assists CRAs in identification of site issues, and associate root causes, corrective action and resolution plans as applicable.
• Ability to write clear, succinct, and detailed clinical study monitoring and study progress reports.
• Maintains open, positive, and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors to successfully achieve all organizational objectives and milestones.
• Participates and represents clinical operations during cross-functional project team meetings.
• Performs other essential functions and responsibilities as determines by the company/manager from time to time.
• Responsible for satisfying the requirements for hospital account and credentialing processes.
• Contributes to department initiatives and process improvement as applicable.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable work performance
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgment
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others

• Additional duties as assigned

BASIC QUALIFICATIONS:

• Bachelor’s degree required or demonstrated equivalent combination of education, training, and experience.
• Minimum five years clinical research experience in a cardiology research environment, medical device trial experience required

• Comprehensive knowledge of GCPs, ICH, FDA, ISO and other applicable regulations governing the conduct of clinical trials.
• Knowledge and experience in clinical trial monitoring and auditing.
• Demonstrates advanced judgement and decision-making ability in the execution and oversight of clinical study sites.
• Excellent interpersonal and relationship building skills.
• Proven leadership/influencing skills.
• Ability to work independently and set/manage multiple priorities.
• Excellent planning, analytical, and problem-solving skills.
• Excellent verbal and written communications skills.
• Ability to work with people at all levels of the organization.
• Proficiency with Microsoft Office, electronic data capture and other computer data acquisition, data analysis, graphing and plotting results and report writing.
• Ability to travel 25% as required.

PREFERRED QUALIFICATIONS:

• Previous medical device industry experience
• Certification as Clinical Research Associate / Professional

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed
• Ability to pass pre-employment drug screen and background check