Site Contracts Associate I - FSP

Parexel • Saint Paul, MN • 4h ago

Parexel FSP is seeking Site Contracts Associates in the US!

Job Summary

The Site Contract Associate I ("SCA") is responsible for negotiation with sites, finalization, and execution of all @types of site contracts required for site activation. SCA is also responsible for ancillary documents associated to site contracts. Post site activation, SCA is responsible for negotiation, finalization, and execution of any amendments to the original contracts. The SCA ensures the highest standard of quality of final documents, as well as their compliance with relevant regulatory requirements, guidelines, and respective country's applicable laws. The SCA ensures that contracts meet needs of both clients and clinical trial sites, protecting best interests of clients and the company (as applicable), while nurturing and maintaining positive relationships with clinical trial sites.

Key Accountabilities :

SCA Tasks:

Draft, review and negotiate all site agreements including but not limited to clinical study agreements, service agreements, team member agreements and other @types of related documents like letters, notices, etc.

Provide @context to comments received from sites in light of local legal and business framework, common practices, and past negotiation experience for the purpose of further review up the decisioning chain.

Apply and scrutinize site contract and related documents and their revisions against negotiation and budget parameters (as applicable).

Ensure final documents comply with applicable laws, regulations, and guidelines, including ICH - GCP.

Ensure the best interest of both clients and Parexel are met.

Serves as key communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.

Manage the contract execution process, including obtaining required signatures and ensuring timely execution of the document by all parties.

Follow record maintenance and archival guidelines to ensure they are met.

Develop and maintain positive relationships with clinical trial sites.

Develop and maintain a thorough understanding of the clinical trial protocol, budget, and timelines to ensure that contract terms align with the overall trial goals and objectives.

Identify potential issues or concerns with contract terms and collaborate with internal stakeholders and clinical trial sites to find mutually acceptable solutions.

Stay up to date with relevant regulatory requirements, guidelines and applicable laws in respective country.

Identifies if all necessary documents, such as Power of Attorney, Insurance Certificates, Indemnification Letters, Informed Consent Form, referenced agreements or any other correlated documents are in line and in place for the need of Clinical Site Agreement.

Track and report on the statuses of site contracting activities to Site Contract Lead, other internal stakeholders and study teams.

SCA is responsible for first time quality by self-check and reviews contracts for completeness and accuracy.

Ensures that changes are appropriately made, approved and documented.

Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon contract tracking system in real time.

Identifies possible contract or process operational risk and proactively works with SCL to provide solutions.

Reviews and complies with Standard Operating Procedures (SOPs) any other relevant applicable guidance in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.

Ensure adequacy and accuracy of archived records.

Identify and implement process improvements to increase efficiency and quality in the site contracting process.

Provide guidance and support to study teams and project management on site contracting matters in the respective country.

Participate in cross-functional communication to identify process improvements and contribute to the development of site contracting strategies.

Skills:

Possess strong negotiation, diplomacy, and excellent organizational skills with demonstrated experience handling multiple projects.

Excellent interpersonal, verbal and written communication skills.

Strong problem-solving skills.

Ability to successfully work in a "virtual" team environment.

Must have strong analytical skills with the ability to create or interpret legal language and budgets.

Maintain grace under pressure while displaying a high level of professionalism.

Align internal and external resources to achieve objectives.

Attention to detail.

Comprehend and interpret contract language.

Identify problems independently and execute solutions.

Quickly comprehend desired end-result, goal or objective and act to accomplish.

Polished presentation skills .

Quality-driven in all managed activities.

Fluent in written and spoken English, command of additional languages is beneficial.

Knowledge and Experience :

Solid working proficiency of all MS Office Products specifically, Excel, Word, and PowerPoint.

SCA I requires 1-4 years of experience in site contracting or combination with a related field within the CRO industry.

Education:

Bachelor's degree in a related field (e.g., law, economics, business, social sciences), equivalent training or industry experience.

LI-REMOTE

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Parexel

Go to Apply

Share this job

Similar Jobs

NetSuite Account Executive - Construction & Energy

Oracle • Saint Paul, MN • 34min ago

Trucking & Construction

Job Description About Oracle NetSuite Do you want to advance your career with the world's first cloud company? Since 1998, Oracle NetSuite has been on a mission to deliver an agile, unified application suite that gives l...

34min ago

Go to Apply

Traveling Construction Special Inspector

Actalent • Minneapolis, MN • 35min ago

Trucking & Construction

Lead Construction Materials Technician (Traveling Role) Nationwide Travel Required | Data Center Projects Overview Seeking an experienced Lead Construction Materials Technician to support large-scale data center construc...

35min ago

Go to Apply

Developer - Java

Pyramid Consulting, Inc. • Minneapolis, MN • 1h ago

IT & Engineering

Job Duties Immediate need for a talented Developer - Java. This is a 12+ Months Contract opportunity with long-term potential and is located in Minneapolis, MN. Please review the job description below and contact me ASAP...

1h ago

Go to Apply

Customer Service Associate

Walgreens • Mendota Heights, MN • 1h ago

Management & Administrative

Job Description: Models and delivers a distinctive and delightful customer experience. Registers sales on assigned cash register, provides customers with courteous, fair, friendly, and efficient checkout service. Custome...

1h ago

Go to Apply

Compass Rose Analyst

Intermountain Health • Saint Paul, MN • 1h ago

Job Description: Clinical Case Management or Compass Rose Analyst. This position is responsible for standard level work supporting information technology application(s) through planning, designing, implementing, maintain...

1h ago

Go to Apply

Cook - Nights/Weekends

Raising Cane's • Shoreview, MN • 1h ago

Retail & Hospitality

Starting hiring pay at: $15.00 As a Cook at Raising Cane's, you will set the pace of the Restaurant by ensuring all of the food we serve meets our high standards. Working in the Kitchen at Raising Cane's is a fun and fas...

1h ago

Go to Apply

Ophthalmic Assistant (COA) or Ophthalmic Healthcare Specialist (Entry-Level)

Minnesota Visiting Nurse Agency • Minneapolis, MN • 1h ago

Hospital & Medical

JOB DETAILS Department:CSC Eye Clinic FTE:1.0 (80 hours per pay period) Workdays:Monday - Friday Shift(s):Days Shift Length:8 hours Location:In-Person Purpose of this position:Under close direction of a certified technic...

1h ago

Go to Apply

Regional Account Manager

Brink's • Saint Paul, MN • 3h ago

Management & Administrative

Pay Range: ?(Minimum to mid pay range specific to NY, CA, CO, WA, MD) 61,700.00 - 77,100.00 USD Annual Brinks Texas License #C00550 #LI-Remote About Brink's: The Brink's Company (NYSE:BCO) is a leading global provider of...

3h ago

Go to Apply

Part Sales Manager - Full Time

AutoZone, Inc. • Anoka, MN • 3h ago

Management & Administrative

Job Description AutoZone's Store Management team drives store performance, fosters a productive team, and ensures exceptional customer service. Managers and MITs play a key leadership role, expected to Live The Pledge an...

3h ago

Go to Apply

Part Sales Manager - Part Time

AutoZone, Inc. • Brooklyn Center, MN • 3h ago

Management & Administrative

3h ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)