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Job Details


Labcorp (Drug Development)

Start-up Associate (2232697)

Pharmaceuticals

All

Yearly

Full Time

No

Burlington, North Carolina, United States

♦ With support from a more experienced start up team member, ensures documents are filed and systems are updated on an ongoing and timely basis making Labcorp ready for an audit at any time.
♦ With support from a more experienced start up team member, develops collecting and tracking regulatory and investigator documents required for effective and compliant study site activation and maintenance.
♦ With support from a more experienced start up team member, ensures that all assigned maintenance and start up activities are on track and support study deliverables.
♦ Follow up with sites in order to ensure documents required are collected in a timely manner.
♦ Escalate study issues appropriately and in a timely fashion.
♦ Update study documents when there are changes in study personnel/study amendments.
♦ With support from a more experienced start up team member, may contribute to the preparation of submissions to IRB/EC with appropriate supervision.
♦ With support from a more experienced start up team member, may review and negotiate site contracts, confidentiality non-disclosure agreements, and other related documents in accordance with defined processes and timeframes under supervision.
♦ With support from a more experienced start up team member, may liaise with Labcorp Contract Specialist and other team members as appropriate to finalize site contract language.
♦ May liaise with Investigator Grant team, Clinical Operations team, and sites to develop, modify, and monitor site budgets and payment terms.
♦ May obtain signatures on site contracts in accordance with defined process and timelines.

♦ With support from a more experienced start up team member, may track the progress of contract and budget milestones, intervening and escalating as appropriate.
♦ With support from a more experienced start up team member, may manage changes to site contracts for amendments and work scope change.
♦ With support from a more experienced start up team member, may review Initial/Amended Investigator Packages to assure compliance with regulatory requirements before granting
regulatory green light to a site to start enrolling patients into the clinical trial.
♦ With support from a more experienced start up team member, may review amended Country/Site Informed Consent Form to assure compliance with sponsor requirements, local
regulatory requirements, and Good Clinical Practice (GCP) guidelines.
♦ With support from a more experienced start up team member, may review Investigator Package Plans that document the required quality of documents included in Investigator Packages following the available SOP with manager oversight.
♦ Ensures high quality site specific and site activation documents are filed in the TMF in a timely manner according to study plans.
♦ Undertake tasks delegated by senior team members, depending upon country and situational requirements with proper supervision.
♦ Perform other duties as assigned by management.

Education
♦ University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical, or laboratory technology).
♦ In lieu of the above requirement, candidates with 2 or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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