Senior Clinical Research Scientist Job

SENIOR CLINICAL RESEARCH SCIENTIST needed for a CONTRACT opportunity with Yoh's client located in EAST HANOVER, NEW JERSEY.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Clinical Trials
- Oncology/Hematology
- Rare Disease/Early Therapeutics

WHAT YOU'LL BE DOING:

- Responsible for the implementation of designated clinical trials including investigator selection, patient recruitment, preparation of trial related documentation (protocols, Case report forms, consent documents, letters of agreement, confidentiality agreements), and organizing Ethics committee submissions.
- Track and manage key trial indictors including: monthly project status, key deliverables to senior management. Accountable for the accuracy and timeliness of trial information in all trial databases and tracking systems.
- Serve as U.S. Local trial lead for multiple global clinical development trials and/or non-registration U.S. Medical Affairs Trials (including phase I-IV, Expanded Access, Investigator Initiated, registries and Compassionate Use). Interface with the oncology therapeutic area global and U.S. clinical team members, clinical operations, scientific operations, regulatory affairs, drug supply, data management, finance, quality, compliance, and other relevant functional areas
- Liaise with study investigators, site research staff, and field based colleagues to support clinical studies. Be the point of first contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing trials.
- Patient Recruitment: track enrollment, develop recruitment plans, and ensure procedures are in place for appropriate optimization of patients into the clinical trial. Manage patient recruitment strategies to increase patient randomization into the trial (eg investigator and research nurse meetings, update newsletters, advertising, letters to GPs).
- Maintain project files including: ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment.
- Manage the Contract Research Organizations - initial identification of a suitable partner, definition of CRO responsibilities, communication plan, divisions of responsibility, milestones, contract with CRO, review monthly status reports, and the interactive management of CRO to ensure project success.
- Review all SAEs, ensure Medical Director sign-off, that sites are notified and that all company procedures are complied with.

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution.
- Significant clinical research or research monitoring experience (comparable to 3 years) that provides the required knowledge, skills and abilities and experience mentoring or training others.
- Effective clinical monitoring skills.
- Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices and applicable Standard Operating Procedures.
- Ability to mentor and train other monitors in a positive and effective manner.
- Ability to evaluate medical research data and proficient knowledge of medical terminology.
- Effective oral and written communication skills, with the ability to communicate effectively with medical personnel.
- Excellent team player with team building skills.
- Ability to work independently as required.
- Good English language and grammar skills.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER:Corrin Pyle

Yoh, a DayJ2W: SCIENTIFIC; MONJOB

TAXTERM: CON_W2J2WMIDATL

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