In-House Clinical Research Associate

636

Workplace Type: Remote

***This is a part-time position***

An In-house Clinical Research Associate will work closely with the Clinical Trial Lead (CTL) and Clinical Research Associates (CRAs) by providing centralized support to regional team members, assisting with the preparation, organization and follow-up of investigator and study site selection, site communications and clinical monitoring tracking both at a regional and global level.

Responsibilities: 

• Provide general support to the CTL and CRAs to manage investigational sites and ensure protocol and regulatory compliance
• Support site identification, qualification & recruitment efforts
• Assist investigational sites with study start-up activities
• Contribute to the development of protocol-specific manuals, plans, and documents as needed
• Assist with the development of training content (monitoring visit training materials, monitoring visit reports, etc.)
• Track patient enrollment and assist with recruitment efforts by maintaining regular site contact
• Assist CRAs with preparation for onsite and remote monitoring visits
• Serve as primary CRA back-up
• May assist with tracking project specific training for site personnel
• Conduct Pre-Study Visits and/or Close-Out Visits as needed; independently as approved
• Co-monitor on assigned studies as needed
• Assist with site quality management activities
• Assist the CTL with Action Item and Protocol Deviation review and follow-up
• Assist with planning of investigator meetings
• Attend investigator meetings as required
• Track submission to and approval from the IRBs/ECs and changes to 1572s
• Develop or contribute to the development of newsletters
• Maintain FAQ list for assigned studies
• Document site and sponsor contact and study interactions in a timely and professional manner
• Assist with resolution of investigational site data queries
• May provide study-specific direction, training, and mentoring to team members
• Other duties as assigned per Advanced Clinical needs

Qualifications:

• Bachelor degree or a two-year nursing degree. Bachelor’s degree in life sciences preferred.
•  1+ years of clinical research experience or healthcare field.
• Excellent verbal and written communications skills; excellent interpersonal and organizational skills with demonstrated attention to detail
• Strong computer proficiency in MS Office including Word, Excel, and PowerPoint
• Strong critical thinking, problem solving and analytical skills
• Ability to efficiently organize and prioritize work within a multifaceted framework and meet deadlines
• Excellent organizational and documentation skills
• Ability to maintain excellent working relationships with a broad range of project/team staff
• Knowledge of GCP as relates to clinical trial management
• Ability to work well in a team environment but also independently without significant oversight. Flexibility in work hours and readiness to travel

***The salary information listed is the amount for a full-time employee.  Since this is a part-time position the actual salary range is €26,304.35-€30,250-€34195.65***

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation.  Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

EEO Employer Verbiage:

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Clinical’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.