Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.
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.
- 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
: Bachelor degree or a two-year nursing degree. Bachelor's degree in life sciences preferred. Experience
: 1+ years of clinical research experience or healthcare field.
The candidate must have:
What's in it for you?
- 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
Advanced Group offers competitive compensation, comprehensive benefits packages, and a flexible work environment designed to help our team members and their families stay healthy, meet their financial goals, and generally thrive in and beyond work. Visit the links below to discover all that Advanced Group has to offer: Our Culture:
https://careers.advancedgroup.com/embrace-our-culture Career Development Opportunities:
https://careers.advancedgroup.com/realize-your-potential Community Programs:
For a complete list of all of our job openings, please visit Advanced Group's career site here .
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, 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 discuss the appropriate alternatives available.