Biosample Operations Coordinator/ Sr. Biosample Operations Coordinator

ESSENTIAL JOB FUNCTIONS:

• This role is a support function to the Biosample Operations Managers. It is primarily administrative in nature with key tasks contributing to operational excellence in sample management. 
• Responsible for assisting the Biosample Operations Managers with the conduct of the sample management aspects of clinical trials, including CRO and vendor management/oversight, ensuring project milestones and objectives are met and clinical study deliverables are consistent with program/company biosample strategy.
• Assist study team in the conduct of sample collections and ensure they are implemented according to the study protocols and in compliance with local, ICH, GCP and company policies and procedures.
• Assist with oversight of sample management activities from start-up to close-out to ensure deliverables are prioritized and goals and objectives are met and/or changed accordingly.
• Assist with the development and review of sample-related documents are in line with clinical protocols, including but not limited to Informed Consent Forms (ICFs), Case Report Forms (CRFs), laboratory manuals.
• Ensures oversight and reconciliation of laboratory documents with the Trial Master File (TMF).
• Assist with ordering and tracking delivery and receipt of lab kits and sample collection supplies to sites.
• Support with tracking sample collection and quality status and providing updates to study team and vendors as needed.
• Assist with the review of study sample related budget management and vendor payments upon CTL requests. Help ensure sample deliverables are on time and within budget and amended accordingly.
• Collaborate with internal and external team members
• Complete other duties as assigned by the manager.

JOB SPECIFICATIONS:

Biosample Operations Coordinator:

1. Candidates should have B.A./B.S. degree in the science/healthcare field, a nursing degree, or equivalent combined education. Associate degrees considered, depending on experience.
2. At least 1-2 years of clinical research/trial experience or relevant work in the pharmaceutical/biopharma industry. Some experience in oncology preferred.
3. Strong computer skills including knowledge of MS Office™ and TEAMS​
4. Willing to take on responsibility 
5. Good organizational and problem-solving skills​
6. Good time and priority management, ability to work efficiently under pressure
7. Good understanding of the policies and procedures of Clinical Operations and of ICH-GCP
8. Potential requirement to travel up to 10%

Sr. Biosample Operations Coordinator:

1. Candidates should have B.A./B.S. degree in the science/healthcare field, a nursing degree, or equivalent combined education. Associate degrees considered, depending on experience.
2. At least 2-4 years of clinical research/trial experience or relevant work in the pharmaceutical/biopharma industry. Some experience in oncology preferred.
3. Excellent computer skills including knowledge of MS Office™ TEAMS
4. Highly motivated, shows initiative, is proactive and able to work independently as well as in a team
5. Strong organizational and problem-solving skills
6. Excellent time and priority management, ability to work efficiently under pressure
7. Excellent understanding of the policies and procedures of Clinical Operations and of ICH-GCP
8. Ability to mentor and coach junior or new staff
9. Willing to take on responsibility and accountability, exhibits Leadership skills
10. Potential requirement to travel up to 10%

While performing the duties the employee is:

1. constantly required to sit, and to reach to use computers and other office equipment
2. occasionally stand for extended periods of time, up to four (4) hours/time.
3. occasionally required to lift up to 10 pounds
4. constantly required to view objects at close and distant ranges
5. frequently required to communicate with others

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

WORK ENVIRONMENT:

Employee frequently works in a professional office environment and lab with lots of computer/lab equipment, tools, and moderate amounts of noise and activity.  Employee may occasionally be required to travel.  The work environment is fast-paced and demanding. Off-shift, weekend and overtime duties may be required as assigned by the manager