Clinical Affairs Specialist

Description

Clinical Affairs Specialist

100% Onsite –(After training and observation of work, could possibly do 4 days in office, 1 WFH)

Duration: This is a 6-month contract with potential to extend highly likely

• This position will include monitoring and oversight of clinical sites to ensure timely and successful execution of clinical studies, resolving study-related discrepancies.
• This position will ensure compliance with protocol and all regulatory policies, procedures, and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions.
• Also, will ensure validity of study by identifying/resolving discrepancies and obtaining missing data and may track more routine aspects of a study. of clinical documents, which may include protocols, case report forms (CRFs), memos, correspondence, reports, and other required documents. Also, conduct new CRA orientation, onboarding, and training activities.

Duties

• Candidate will proactively identify, and address issues related to study monitoring and clinical site management.
• Track and communicate monitoring and site management updates and issues; escalate monitoring-related study timeline and quality risks to the Clinical leadership.
• Maintain clinical operations processes, new employee onboarding, internal protocol training, monitoring tracking tools and study tools/templates for CRAs and site personnel.
• Manage CROs/vendors for outsourced activities as applicable, including sponsor oversight of relevant functional activities (e.g., study management, monitoring, site management, project master files, and data management).
• Ensure adherence to Good Clinical Practices, Industry standards, standard operating procedures and to all other regulatory and quality standards in conducting Lingo Clinical research and development.
• Operate under minimal supervision and demonstrate a high degree of proficiency.
• Undertake additional projects and tasks as determined by department and organizational needs.
• The successful candidate will demonstrate the ability to work collaboratively across
• cross-functional teams, including Quality, Compliance, Product Development, and Engineering, etc.
• They should have prior experience in Clinical Research or Clinical Trials and a solid understanding of related processes.
• This role requires someone who is a quick thinker, adaptable to evolving workflows, and proactive in seeking clarification when needed.
• This role requires a resourceful and agile individual who can think critically, adapt to evolving workflows, and proactively seek clarification when needed. The ideal candidate will also demonstrate creativity in problem-solving and be open to exploring innovative ideas and process improvements.
• The ideal candidate must be able to quickly learn internal processes and demonstrate the ability to work independently with minimal supervision.
• While support is always available, this role requires someone who can take initiative and adapt quickly in a fast-paced environment.

Education:

• Education Level-bachelor’s degree-Major/Field of Study- Biology, Health Sciences, Mathematics, Computer Science, or equivalent

Licenses and Certifications

• None required; Certified Clinical Data Manager (CCDM) or equivalent nice to have but not required..