In-house Clinical Research Associate

Overview:
An In-house Clinical Research Associate will work closely with the Lead CRA and Clinical Research Associates 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 local and international level.

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.

**Responsibilities**:

- Support Site Identification, Recruitment & Qualification
- Be first line of contact to direct or address non-medical site questions
- Perform study tracking to ensure that all study files and documents are accurate, current and complete.
- Perform essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements, ICH/GCP guidelines and SOPs.
- Provide general support to the Lead CRA and CRA in order to manage the investigator sites and ensure compliance
- Develop or contribute to newsletters for assigned studies based on information provided by Project Team.
- Maintain FAQ list for assigned trial(s)
- Confirm and track that all key site personnel have project specific training.
- Document site and sponsor contact and study interactions in a timely and professional manner.
- Assist with resolution of investigational site/data queries.
- Liaise with project team members regarding study site issues.
- Provide quality review of the informed consent template
- Track submission to and approval from IRB, 1572 changes (including obtaining medical licenses and CVs related to these changes) correspondence, site changes.
- May provide study-specific direction, training and mentoring to CRAs, and support staff as appropriate, and may provide guidance to other team members.
- Travel to sites and meetings as needed.
- Other duties as assigned and may change with change in studies/Advanced Clinical needs.

Qualifications:
Education: Bachelor’s degree, in biological sciences or healthcare
Experience: 3+ years related experience. Clinical trial experience level experience (CRO, healthcare settings and industry experience are acceptable). Prefer scientific discipline and multiple therapeutic experiences.
- 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 skill sets.
- Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.
- Excellent organizational and record-keeping skills.
- Ability to maintain excellent working relationships with a broad range of trial 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.
**At Advanced Group, 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 Group in delivering ser**vices 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 Group’s practice not to discriminate against any Employee or applicant because of sex, r