Scientific Affairs Analyst
Job Title: Scientific Affairs Analyst
Department: Scientific Affairs
Location: Remote, United States
Hours Per Week: 40 hours
Schedule: Days, Monday – Friday
SUMMARY
The Clinical Trials Scientific Affairs Pre Award Analyst is responsible for the review of study protocols and investigating testing requirements to assist in facilitating the timely response for proposals. Coordinates the testing methods as needed with ACM Research & Development, ACM Laboratory and referral laboratory partners for study support and set up. The CTSA Analyst will act as a link and interface between the laboratory and other departments; ie sales, proposals and project management.
RESPONSIBILITIES
Investigate testing requirements within a clinical trial protocol and help determine testing facilities to identify required testing and associated nuances for the timely and accurate response for proposals
Review and prepare pricing documents, as needed, noting any discrepancies
Maintain relationships between ACM and referral laboratories
Provide scientific/ technical information to compile client RFP’s and RFI’s
Provide feedback to the manager to address analytical trends or issues, to support business needs
Assist in coordinating the testing methods with referral labs, as needed
Obtain and document referred testing information throughout the course of the active trial, including contracting with referral labs
Investigate and implement corrective actions as needed.
Assumes responsibility for channeling information to and from Laboratory Operations and Sales.
Alert leadership to any issues during the life cycle of study related and testing needs
Alert leadership to any issues with referral laboratories
Makes suggestions to manager for improved work methods and ways to increase efficiency, reduce costs, and solve operational problems.
Understands and follows company policies and procedures and respecting patient confidentiality
Liaison with internal and external partners and participate in client teleconferences to address new business needs or ongoing study issues
Assist with training of new team members
Provide consultation to clinical trials operations and external clients, as needed
Perform other duties as assigned.
REQUIRED QUALIFICATIONS
Bachelor’s Degree or 3+ years as a clinical laboratory scientist
2 years relevant laboratory experience
1 years clinical trials experience
PREFERRED QUALIFICATIONS
Strong interpersonal and communication skills
Strong time management and organizational skills
Ability to manage multiple projects with tight deadlines
Ability to work independently and in a team setting
Proficient in Microsoft Office
Generalist laboratory experience
Ability to lead and positively motivate others
MT (ASCP) Certification - Preferred
EDUCATION:
BS (Required)
LICENSES / CERTIFICATIONS:
PHYSICAL REQUIREMENTS:
S - Sedentary Work - Exerting up to 10 pounds of force occasionally Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements.
Any physical requirements reported by a prospective employee and/or employee’s physician or delegate will be considered for accommodations.
PAY RANGE:
$70,000.00 - $90,000.00
CITY:
Rochester
POSTAL CODE:
14624
The listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the future and eligible for additional pay components. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.
Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.
Department: Scientific Affairs
Location: Remote, United States
Hours Per Week: 40 hours
Schedule: Days, Monday – Friday
SUMMARY
The Clinical Trials Scientific Affairs Pre Award Analyst is responsible for the review of study protocols and investigating testing requirements to assist in facilitating the timely response for proposals. Coordinates the testing methods as needed with ACM Research & Development, ACM Laboratory and referral laboratory partners for study support and set up. The CTSA Analyst will act as a link and interface between the laboratory and other departments; ie sales, proposals and project management.
RESPONSIBILITIES
Investigate testing requirements within a clinical trial protocol and help determine testing facilities to identify required testing and associated nuances for the timely and accurate response for proposals
Review and prepare pricing documents, as needed, noting any discrepancies
Maintain relationships between ACM and referral laboratories
Provide scientific/ technical information to compile client RFP’s and RFI’s
Provide feedback to the manager to address analytical trends or issues, to support business needs
Assist in coordinating the testing methods with referral labs, as needed
Obtain and document referred testing information throughout the course of the active trial, including contracting with referral labs
Investigate and implement corrective actions as needed.
Assumes responsibility for channeling information to and from Laboratory Operations and Sales.
Alert leadership to any issues during the life cycle of study related and testing needs
Alert leadership to any issues with referral laboratories
Makes suggestions to manager for improved work methods and ways to increase efficiency, reduce costs, and solve operational problems.
Understands and follows company policies and procedures and respecting patient confidentiality
Liaison with internal and external partners and participate in client teleconferences to address new business needs or ongoing study issues
Assist with training of new team members
Provide consultation to clinical trials operations and external clients, as needed
Perform other duties as assigned.
REQUIRED QUALIFICATIONS
Bachelor’s Degree or 3+ years as a clinical laboratory scientist
2 years relevant laboratory experience
1 years clinical trials experience
PREFERRED QUALIFICATIONS
Strong interpersonal and communication skills
Strong time management and organizational skills
Ability to manage multiple projects with tight deadlines
Ability to work independently and in a team setting
Proficient in Microsoft Office
Generalist laboratory experience
Ability to lead and positively motivate others
MT (ASCP) Certification - Preferred
EDUCATION:
BS (Required)
LICENSES / CERTIFICATIONS:
PHYSICAL REQUIREMENTS:
S - Sedentary Work - Exerting up to 10 pounds of force occasionally Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements.
Any physical requirements reported by a prospective employee and/or employee’s physician or delegate will be considered for accommodations.
PAY RANGE:
$70,000.00 - $90,000.00
CITY:
Rochester
POSTAL CODE:
14624
The listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the future and eligible for additional pay components. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.
Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.