Clinical and Regulatory Affairs Associate

POSTED: November 19, 2018
BUSINESS: Concordance Health Solutions
POSITION TYPE: Full-time, open to candidates seeking part-time
START DATE: Immediate Availability

Concordance Health Solutions (CHS) is a startup company that is developing products, services, and data to improve patient medication adherence in partnership with pharmacists, healthcare providers, and payers. Our products include electronic reminder and monitoring technologies that are simple to integrate into healthcare systems and practice, inexpensive, and fit seamlessly into a patient’s lifestyle.

The Clinical and Regulatory Affairs Associate will oversee tasks related to clinical and regulatory activity for the company. The role provides direction and support to internal staff and partner organizations engaged in patient-facing and regulatory functions that further commercialization goals of the company. This includes clinical research and demonstration activities, patient support functions, and regulatory interactions and submissions.

Duties include:

• Initiate and oversee clinical research projects, including preparing and shepherding IRB approvals, creation of policies and procedures, overseeing recruitment and enrollment of subjects, and managing project tasks and outcomes.

• Develop and implement regulatory strategies to facilitate commercial adoption of Concordance’s products with target customers

• Oversee patient support functions, including developing strategies to drive optimal engagement and persistence with products, in collaboration with product owner.

• Assist with applications and reporting tasks required by government and private funding agencies

• Engage industry experts and academic partners that elevate the visibility and stature of Concordance’s products in healthcare

• Participate in and contribute to the strategic and operational excellence of the organization within a culture of continuous improvement

Qualifications:

• Bachelor’s degree or above with at least 3 years of Clinical experience, or an equivalent combination of education and experience; background in nursing, medicine, or medical practice-related area preferred.

• Familiarity with the essential components of clinical operations, medical terminology and routine medical tests and procedures

• Understanding of Good Clinical Practice (GCP) standards • Experience in clinical research related activities desired (e.g., monitor, study coordinator, or similar experience); knowledge of statistical design and analysis a plus

• Possess strong interpersonal, oral and written communication skills in order to effectively and independently oversee clinical operations and communicate results.

• Strong ability to demonstrate diplomacy and negotiation skills, as well as the ability to persuade when necessary.

• Able to confidently interact with all levels of management including senior management, researchers, medical practitioners, and others.

• Ability to develop relationships and form solid collaborations is critical.

Interested applicants may send resume and cover letter to Deb Parent dparent@ConcordanceHealth.com

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