Summary of the Essential Functions of the Job

• Responsible for evaluation, initiation, monitoring, close-out and other tasks associated with the management of clinical sites. Ensure the conduct of all clinical studies is in accordance with Good Clinical Practices, International Harmonization Guideline, and appropriate Standard Operating Procedures (SOP)

• Serve as primary contact for CROs/vendors, Investigators and study coordinators for study related questions.

• In conjunction with study team, support feasibility and site selection process for clinical studies.

• Assist and support development and review of clinical protocols, informed consent forms, or other study-related clinical documents (e.g. Case Report Forms, Source Documents, Monitoring Plan, Data Management Plan, Project Management Plan, etc.)

• Manage patient recruitment strategies to increase patient randomization into the trial (e.g. investigator and research nurse meetings, update newsletters, advertising, letters to GPs).

• Review all AE/SAEs and ensure appropriate documentation is in place and any other safety issues are addressed and communicated.

• Assist and support data validation and data cleaning procedures to ensure timelines are met.

• Order and coordinate study supplies for clinical studies

• Develop and maintain tracking tools to support management of clinical studies

• Plan and participate in Investigator meetings and CRA trainings

• May accompany CRO/CRA’s to co-monitor activities at clinical study sites to assure adherence to Good Clinical Practices (GCP’s), SOP’s and study protocols

• The role will also provide guidance, clinical trial management and direction to other junior Clinical Research Associates.



Minimum Requirements

• Position requires BA/BS or RN, preferably in the Life Sciences
• Minimum of 5+ years of experience in the pharmaceutical / biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock.
• Strong Oncology (liquid and solid tumor) monitoring experience in phase 1-3 pharmaceutical/ biotechnology clinical trials
• 2 yrs oncology, willing to work on derm or GVHD, willing to be a CRA
• Possess good understanding of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant, local regulatory requirements
• Good knowledge of concepts of clinical research and drug development
• Strong working knowledge of EDC, IVR and CTMS systems
• Ability to handle and prioritize multiple studies and projects. Ability to work effectively in a team/matrix environment. Ability to understand technical, scientific and medical information
• Demonstrated strengths in planning, organizational, project management, analytical skills, oral and written communication, time management, conflict management, problem solving, attention to detail, and interpersonal skills
• Ability to travel 70-80%
• 8-10 sites/ 4-5 protocols max 
• At least 3-5 years monitoring/site management experience in Oncology Phase I-III (liquid and solid tumor experience required

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

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. Advanced Group is committed to providing employment opportunities without regard to 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.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].