Regional Clinical Research Associate, Louisville-Lexington KY

Company: Novo Nordisk ( Learn More )

General Information
US-KY-Louisville
N/A
Not Specified
Full-Time
Not Specified
Not Specified
False
False
Job Description Requisition ID 50865BR
Title Regional Clinical Research Associate, Louisville/Lexington KY
Job Category Clinical Development
Job Description PURPOSE:

Responsible for performing study activities regarding the implementation, monitoring and summarization of clinical trials to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs. Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within CMR.

RELATIONSHIPS:

Reports to a Manager/Senior Manager/Associate Director of Field Management (FM) within CTM.
Accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of assigned project milestones. External relationships are with clinical investigators, and other clinical research vendors as needed to support business objectives for the department and/or function.

ESSENTIAL FUNCTIONS:

* Ensures compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.
* May participate in continuous improvement processes for function.
* Acts as primary liaison for assigned study sites while on-site to convey project information, answer questions and resolve site-related issues in accordance with the CTM escalation pathway to the Lead CRA .
* Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of site related performance and documentation. Prepares, collaborates and implements Corrective Action Plans (CAP) with investigative sites with oversight from Lead CRA.
* Assures adequate and appropriate dissemination of information between project team members to ensure project success in accordance with the CTM Communication Pathway or Project Specific Communication Plan.
* Attains thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and NNI SOPs.
* Attends Investigator Meetings and study-specific training for assigned trials.
* Attends site audits according to the CTM Audit Management Plan and executes audit action plans with support from Lead CRA/PM as appropriate.
* Collaborates with the Lead CRA(s) to obtain/share trial-specific issues across all study sites concentrating on areas related to quality, site performance and metrics. Responsible for communicating issues in accordance with the CTM escalation pathway to the Lead CRA(s) as appropriate.
* Completes Site Selection, Site Initiation, Routine Monitoring and Close-out Visits according to SOPs, and completes reports and follow-up letters to quality standards within company specified timelines.
* Develops and maintains collaborative working relationships with clinical investigative sites. Accountable for data integrity, patient safety and regulatory compliance for all assigned sites.
* Knowledgeable of assigned protocol(s) and trial-specific manuals/plans to ensure quality and deliverables are met across assigned sites. Maintains current Investigator Trial Files (ITF) in accordance with NNI SOPs. Performs ongoing reviews of ITF to assure quality of the documentation and compliance with NNI SOPs, GCP and ICH Guidelines while on site.
* Monitors recruitment and data quality while on site and remotely through EDC systems and communication with sites.
* Performs on-site drug accountability, reconciliation and return. Verifies trial product storage meets protocol and SOP requirements.
* May provide guidance, mentoring and training to less experienced CTM staff to build talent across the department.
* May support the maintenance of guidelines, training programs, policies and procedures.
* Active participation on local project teams.
* Ensures the mandatory trial entries are made in the applicable NN systems.
* Maintains focus for specific project activities within CMR priorities.
* Participates in cross-functional teams, locally, to assure timely attainment of project milestones.
* Responsible for the compliance and quality of CATS reporting for self.
* Attends relevant symposia, conferences and scientific meetings, as necessary.
* May provide support of training needs across CTM and may support the creation, development and potentially provide training support to meet those needs. This includes sharing of lessons learned across the project team members and/or CTM.

PHYSICAL REQUIREMENTS:
* 50-75% overnight travel required
* Must live within 50 miles of the regional workload center within assigned region.
DEVELOPMENT OF PEOPLE:

* Not Applicable
QUALIFICATIONS:

* A minimum of 2 years of on-site monitoring experience (with Bachelors degree) or 3 years of on-site monitoring experience (with RN).
* A minimum of 4 years of clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting; some experience in area of specialty preferred.
* A Registered Nurse (RN) or Bachelor’s degree required (in science-related discipline preferred).
* Demonstrated computer skills (MS Office, MS Project, MS PowerPoint).
* Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
* Knowledge of GCP as relates to clinical trial management.

Department CMR - FIELD MGMT MIDWEST (1)
Position Location US - Field Based - Across US
City Louisville/Lexington
State/Provinces US - KY

At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness

With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!

Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.

Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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