Integrium is full-service Clinical Research Organization (CRO) entering its 23rd year of business, focused on pharmaceutical and drug development within the therapeutic areas of Cardiovascular, Metabolic (Diabetes), Oncology, Renal Inflammatory, Dermatology, Wound Healing, Regenerative, Gene Therapy, and Orphan Diseases. We are looking for a ClinicalResearchAssociate (CRA) to join our growing team.
The CRA will travel (possibility of occasional remote monitoring) throughout the USA in South/North Western, South Central and South Eastern regions to visit clinical research sites to ensure that the rights, well-being, and safety of human subjects are protected. The CRA will perform and coordinate all aspects of the clinical monitoring process in compliance with ICH/GCP guidelines along with Integrium SOPs. Our ideal candidate must have a strong attention to detail, accuracy, and commitment to quality.
ESSENTIAL JOB FUNCTIONS:
· Available to travel up to 80% of the time, primarily within the regions indicated, with preference for those maintaining a residence within 45-minute drive-time of a major USA airport.
· Demonstrate current knowledge of GCP’s, federal regulations and other applicable regulatory agencies; sound knowledge of disease process under study and related medical/scientific information.
· Ensure data reported in site source documents is accurate, complete, and verifiable.
· Maintain ongoing and continuous professional communication with the clinical sites and the Integrium team during the duration of the study.
· Excellent problem-solving skills.
· Must be customer oriented and flexible.
· Must be able to work independently and in a team environment plus work well with others in high-pressure situations.
· Must have a reliable form of personal transportation (including automobile insurance coverage if/when choosing to use personal vehicle for business use), be capable of following corporate travel and expense policies consistently and manage reimbursement of business travel expenses via personal credit card and maintain both a solid credit history and DMV driving record to enable access to rental car use when traveling on business and/or use of ride-hailing services.
EDUCATION & EXPERIENCE:
· Bachelor’s degree in health sciences or related field. Nursing degree is a plus.
· Must have four (4) to six (6) years of CRA experience in the CRO/Pharmaceutical industry.
· Must have both experience working remotely plus onsite monitoring experience (Diabetes experience preferred).
· Exceptional organizational and time management skills with ability to multi-task to assure timely completion.
· Excellent ability to communicate effectively and clearly, both orally and in writing.
Integrium offers comprehensive, contributory health plans consisting of Medical, Dental and Vision Insurance. We also offer life insurance, short and long-term disability, and long-term care plans. The Company offers a Flexible Spending Account and 401(K) plans in which you may participate.
Integrium is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by State, Federal or local law.
Additional Salary Information: Based on years and level of experience
Integrium was founded in 1998 by clinical research thought leaders who wanted to build a CRO based on therapeutic focus and excellence. These individuals continue to lead the company today. We have offices in North America, and formal alliances with partner CROs regionally and in Europe, Australia, and India.Integrium is a full-service Clinical Research Organization focused within the therapeutic areas of Cardiovascular, Metabolic, Renal, Oncology, Inflammatory, Dermatology, Wound Healing, Regenerative, and Orphan Disease. Although we have the scientific, medical, operational, and regulatory expertise to cover all stages of clinical development (Phase I-IV), we are Experts in the Strategy, Design and Execution of Phase Ib, IIa and IIb Trials.