Clinical Operations Specialist

Purpose: Summary: As a member of the company?s Clinical department, the Clinical Operations Specialist International will provide in-house support of clinical trials by providing continuity of workflow between Investigative sites, clinical staff and outside consultants/vendors. This position will allow for exposure to clinical monitoring through co-monitoring visits and other training.


RESPONSIBILITIES:

-Project specifications/Clinical tracking: Assists with the design, development, and production and distribution of case report forms/CRF binders, study manuals and patient related handouts/binders. Maintains workflow of projects while staff is traveling, providing continuity of communication between Investigators and their staff, internal clinical staff and consultants.

Builds and maintains databases to track study status and site progress; i.e. patient enrollment, regulatory documents, contract and budget negotiations and follow-up with sites/CRAs regarding missing documentation.

-Informed Consent (IC): In conjunction with site CRA, reviews informed consent forms for compliance with THE COMPANY?S standards, FDA and HIPAA regulations prior to final approval by Project Manager. Also interfaces with investigative sites personnel regarding ongoing changes and final IC.

-Meetings: Coordinates activities for clinical project meetings; i.e. FDA advisory, consultants and investigator(s). Works closely with meeting planner, coordinates hotel, meeting facilities, travel and meeting materials including presentations and handouts. May be asked to attend said meetings to facilitate, as needed. Processes meeting related expense reports.

-Special projects: Lead role in managing small to large scale projects such as timely mass mailing of correspondence.

-Administrative: Maintains clinical study files in accordance with FDA and ICH guidelines.
Maintains hard copy of scientific documents archives. Drafts and distributes meeting agendas; takes minutes at clinical team meetings, with particular attention to action items and timelines. Circulates final minutes to internal and external clinical staff. Maintains clinical team project calendar including travel schedules and monitoring visits. Performs other tasks as assigned, i.e. literature searches.


QUALIFICATIONS:

1.BA/BS with excellent communication and organizational skills.
2.Experience as an administrative assistant/CRC with 3-5 years experience required.
3.Must have 2+ years international experience.
4.Familiarity with clinical development, FDA and ICH regulations and HIPAA guidelines.
5.Must be self-motivated and able to: work with limited supervision, follow directions precisely, prioritize multiple tasks and manage a large volume of work, handle a moderate amount of pressure, show attention to detail and complete timelines within established deadlines..
6.Ability to assess, coordinate and organize/reorganize workload in accordance with project timelines with focus on execution. Must be a problem solver and a collaborative team member.
7.Strong interpersonal skills and professional attitude are essential as this individual interacts with many people of varying levels of responsibility for clinical studies and business performance.
8.Must have excellent computer skills including software packages (PowerPoint required).
9.Must attend annual clinical research development training classes, to be selected with input from Medical Monitor and/or Project Manager.
10.Must be able to travel to international locations.Classification:ContractCompensation:
based on experience HourJoin Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries is an equal opportunity employer.

Required Qualifications:
Skills Requirements:
CRF Design Assist, Database Maintenance, Patient enrollment, Regulatory Documentation, Informed Consent Forms, BA/BS, 3-5 Years Pharma Exp., ICH RegulationsContact Information
Contact:Beckman,Ryan