CenterWatch

1+ months

Clinical Contracts Associate

Kelly Services
Foster City, CA 94404
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Clinical Contracts Associate** at a prestigious Fortune 500 company working in **Foster City.**





**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the Submit Resume button included within.





**Job Title: Clinical Contracts Associate**





**Purpose**

The Development Business Operations Associate II in the Document Management Team (DMT) will collaborate with Development Business Operations functional groups, Clinical Records and Clinical Operations study teams in the planning, development, and implementation of standards, processes, and projects for DMT designed to ensure the effective and efficient archiving of clinical agreements and related information created in support of clinical research. Comply with relevant regulatory, legal, country specific and corporate requirements to produce and maintain inspection readiness for clinical records.


**Key Accountabilities / Core Job Responsibilities**

Maintain thorough and current knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical agreements

Collaborate with Development Business Operations functional groups, Clinical Operations study teams and functional areas outside of Development Business Operations to ensure compliance with policies, procedures, and the practices of Gileads records management/TMF archival initiative

Work with management and DMT personnel in the development, implementation and maintenance of classification and filing systems to meet administrative, research, regulatory, legal, and financial requirements (e.g. filing of agreements in Gilead legal archive, Apttus, and eTMF GDAR and Veeva)

Work with management to manage business continuity procedures, including management of paper agreements

Perform central intake activities including creating records of incoming documents within the first business day of receipt, filing of incoming documents, and retrieve copies of paper protocol agreements from TMF room for Apttus filing

Collaborate with management to establish and generate central intake reports

Responsible for keeping DMT Master Inventory up to date and accurate

Evaluate regulatory and Gilead business recordkeeping, archiving requirements, and organizational objectives and ensure Development Business Operations DMT is aligned with all

Responsible for the continued maintenance of eTMF (GDAR) and Apttus contract filing

File incoming documents and retrieve copy of paper protocol agreements from TMF room for Apttus filing

Ensure record filing is kept up to date and is performed accurately by DMT members

Develop and maintain department process guidance, training materials, policies and procedures, and other quality documents

Define and manage processes associated with the storing, archiving, indexing, scanning, and classifying records

Manage the off-site storage of records for Development Business Operations agreements and collaborate closely with Gilead Clinical Records team to ensure proper process is in place for off-site archival of paper agreements

Collaborate and partner with the Information Technology (IT) GDAR and Veeva Teams, through stellar communication and solid project management. Resolve efficiently any issues encountered by collaborating with IT in the improvement of processes, procedures, and effective use of available information technologies

Develop into the Subject Matter Expert (SME) in the electronic TMF (eTMF) filing process, especially in Veeva

Respond to internal and/or external information inquiries related to contract filing and records retention of those agreements; supports internal and external audits and inspections, including provision of data on contract filing

Manage the DMT mailbox by responding to daily email inquiries, review of incoming agreements for technical review and uphold the contemporaneous filing requirements and SLA turnaround time in eTMF (GDAR and Veeva) and Apttus

Participate in the development, implementation and maintenance of internal systems and processes used to manage collections of agreements and filing of documents to GDAR, Veeva and Apttus

Track and maintain departmental metrics related to operational activities, progress of contract filing and archive, quality measurements and other variables. Develops appropriate tool sets for capturing metrics and generating reports.

Responsible for the day-day activities associated with the quality check of clinical agreements and management of contract filing and archival

Ensure appropriate documentation completed to track archival of files

Support Development Business Operations Functional Teams and Clinical Operations Study Teams in understanding TMF-related responsibilities, requirements and expectations

Manage Development Business Operations TMF protocol list for legacy and active protocols and Development Business Operations TMF Comprehensive Review Trackers and Agreements Missing in TMF

Provide management with DMT metrics; completeness and quality of TMF documentation and content, including the percent completeness and risk level of outstanding items on a periodic and/or ad hoc basis as requested by management


**Qualifications**



3-4 plus years of project or clinical trial coordination/management experience

3 plus years of Clinical Research Associate (CRA) or relevant records management/ TMF management experience equivalent experience preferred



Experience with change management

Exemplary interpersonal skills with proven demonstration

Knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and GCP guidelines related to Clinical Document Management

Proficiency in MS Project and standard desktop tools including, but not limited to, MSWord, Access, PowerPoint, Visio, and Excel

BA/ BS required





**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com at http://www.kellyservices.com/ **.**



**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**



**Kelly Services is an Equal Opportunity Employer**










**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2019-10-11 Expires: 2019-12-12

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Clinical Contracts Associate

Kelly Services
Foster City, CA 94404

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