The Clinical Research Development Coordinator supports and assists in the operational planning, management and execution of multiple phase II/III international trials.
This position contributes to the development of trial-related scopes of work, costs, time lines, metrics and deliverables.
This position will focus on clinical vendor project management to ensure the completion of the vendor study deliverables, milestones and objectives. The position will be responsible for coordinating the internal team and core members to manage external vendors, and providing support to trial teams.
- Bachelor's degree
- phase II, III, or IV trial experience from pharmaceutical company or large CRO, 3+ years
Master's degree in business or health care.
* Previous supervisory experience may be helpful.
* Must possess high degree of diplomacy and professionalism in handling confidential information and maintaining productive relationships with CCS personnel, other WUMC personnel, external sponsors and other customers. Independent judgment and decision-making a must in planning and executing programs and supervising/advising others.
* RN, or equivalent extensive direct clinical trial work experience in industry-regulated environment. Experience at a CRO and/or pharmaceutical environment strongly preferred.
* Minimum of 5+ years' experience in clinical research, project/program, and vendor and management.
* Experience in clinical trial start-up, maintenance and close-out.
* CRA, CRC, or PM experience in protocol development (trial design) and a strong understanding of the operational execution of clinical protocols from a sponsor perspective.
* Good comprehension of drug development and clinical trial methodology.
* Proficient in ICH/GCP and industry-regulated IND trial requirements and an ability to assess compliance to these guidelines.
* Ability to organize and manage multiple vendors participating in clinical studies. Specifically, computerized cognitive testing and central laboratory vendors.
* Willing to travel as necessary (i.e. investigator meetings, seminars or company meetings, etc.).
* 5+ years of experience in clinical operation, preferably at a pharmaceutical, biotechnology company or CRO.
Experience managing FDA-regulated phase II and III therapeutic intervention trials is strongly preferred. Global experience is desirable.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.