Site Contracts Specialist/In-house CRA

Pharm-Olam International - Raleigh-Durham, NC (30+ days ago)3.1


About Pharm-Olam International:
Pharm-Olam International is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.

Primary Responsibility:
Site Contract Specialist reviews, negotiates and drafts clinical trial agreements, amendments and related documents, interacts with sites on contract and operational issues, and various other initiatives and projects to support the research contracting process. Provides project oversight and instruction, mentors and supports for the In-house Clinical Research Associate (CRA) team as it relates to site contracts and budgets process. Works together with Pharm-Olam's project teams to ensure all In-house CRA activities as it relates to the clinical trial agreement process are completed within project time-lines and in accordance with all applicable regulations, guidelines, and Standard Operating Procedures.

Secondary Responsibility:
In-house Clinical Research Associate (CRA) serves as a core team member, and in-house support for the clinical team, and coordinates site start-up operations. For awarded projects, leads activities of local feasibility, as well as site identification. With appropriate training, may perform selected on-site visits for specific projects. Performs site management activities to assist the field monitors. Works together with Pharm-Olam's project teams to ensure site start-up activities are completed within project time-lines and in accordance with all applicable regulations, guidelines, and Standard Operating Procedures.


Contracts and Budgets:
Negotiates contracts and budgets with investigative sites;
Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
Collaborates with internal project team to ensure negotiations occur within time-lines.
Independently track status of clinical study agreements to ensure project time-lines are met;
Tracks and measures project and team progress through collection of cycle time metrics and other quality key performance indicators (KPIs). Communicates metrics, KPIs, and other relevant project information to team and departmental leadership. Proposes solutions to issues that may arise during a project or contract life cycle.
Facilitates the execution of contracts by company signatories.
Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
Serve as a liaison between Sponsor, investigative sites and Pharm Olam
Tracks milestones in contract database and follows-up with Sponsors as required.

In-House CRA:
Trial Master File quality control reviews
Internal site management
Telephone calls and visit reports, as well as co-monitoring with a focus on Investigator Site File reconciliation
May perform on-site visits for specific projects, as appropriate and as required

Study Start-up Coordination and Execution:
Coordinates, guides, and assists with all start-up activities prior to site activation, including but not limited to site identification, feasibility and selection.
Reconciles and interprets feasibility data, providing solid recommendations to internal stakeholders.
Conducts site evaluation visits (SEVs) as required
Essential document collection, review, and preparation for IP release sign off
Collects IRB/EC information, meeting dates, and costs
Contract and budget negotiations through to execution leading to site activation
May complete central IRB/EC applications and submissions via on-line systems.
Ensures all start-up information and requirements are kept accurate and up to date in a central repository for project teams
Tracks metrics and site start-up time-lines to identify trends and opportunities for improvement
Ensures overall project site start-up efficiency and adherence to project time-lines and report metrics
Ensures accurate completion of relevant Clinical Trial Management System (CTMS) fields in accordance with role

Relationship Management:
Maintains up-to-date understanding of clinical trial agreement and start-up processes by liaising with team to improve overall efficiency of the group
Maintains communication with In-house CRA team, field CRAs, sponsor, and sites
Tracks and drives site activations by regular review and monitoring status of cycle times for clinical trial agreement process
Maintains up-to-date understanding of site start-up processes by liaising with key internal stakeholders, and looks for emerging trends across the industry to evolve the team and to resolve any issues
Provides continuous and proactive communication with IRB/ECs, hospital administration, etc. to obtain accurate and up to date information on clinical trial status and activities
Maintains communication with local and central legal, regulatory, IRB/EC, tracks and drives site activations by regular review and monitoring status of site submissions and/or activations

Working Relationships:
Report to Clinical Research Manager or COM
Liaise and collaborate with project team members, sites, clients, vendors, and varied facets of the organization

Prior contract negotiation or paralegal experience required
Bachelor Degree preferred
Experience in a contract research organization or pharmaceutical industry essential.
Strong knowledge of the clinical development process and legal and contracting parameters.
Strong Interpersonal, facilitating and negotiation skills
Strong organizational, planning, strategizing, managing, monitoring, scheduling, and critiquing skills
Excellent written and verbal communication skills to clearly and concisely present information
Excellent interpersonal skills and strong team player; ability to coordinate and collaborate above, across and within complex projects in a fast-paced, deadline oriented, and changing environment
Excellent negotiation skills with ability to challenge without alienating internal and external stakeholders
Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
Ability to exercise independent judgment taking calculated risks when making decisions
Ability to establish and maintain effective relationships with co-workers, managers and sponsors
Strong computer skills with an ability to understand access and leverage technology alternatives
Proficient in use of Microsoft Word, Excel and PowerPoint
Experience in CRO, pharmaceutical or other relevant area
Occasional travel

For Consideration:
Due to the number of inquiries, we are unable to respond to each inquiry. Candidates of interest, matching the above qualifications will be contacted for further consideration.