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Lead CRA, Low Local Travel
- Work at Home Jobs, Work from Home Jobs
Company: Aerotek Scientific .
Location: Boston, Massachusetts .
Category: Clinical Jobs .
Rate: $55 to $65 per Hour .
Job Type: Contract .
Posting ID: 1157213 .
Posting Date: 3/19/2007; Allegis Group Family of Hiring Companies .
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Lead CRA, Low Local Travel Job Description:
Our client, a CRO in the Boston area is currently looking for a Lead Clinical Research Associate in their recently established Clinical Site Management group. This is a new position created to help accommodate the rapid growth of the department. The Senior CRA will participate in the planning, design and execution of clinical trials to ensure quality, safety, and effectiveness of the Sponsor?s products while working collaboratively with internal and external project team members.
This position will be in house in their Boston facility for at least the two months. After the study is up and running, the Lead CRA will be allowed to work from a home office. The travel for this position is very minimal, most of the sites are in the Boston area. Interested applicants should email a Word Version of their resume to Stef Carrabba at scarrabb@aerotek.com.
Primary Duties:
- Responsible for overall conduct of multiple clinical trials
- Establish and maintain primary communication with clinical sites and in-house and regional clinical research associates.
- Acts as Sponsor liaison to resolve any site related issues quickly and effectively.
- Reviews protocol and assists with and approves case report form design.
- Generates monitoring plan for assigned studies.
- Participates in the site/investigator selection system/process.
- Participates in completion of study related documents including informed consent form, protocol, Case Report Forms, template source documents, training manuals, regulatory binder, and other resource materials.
- Independently conducts all types of monitor visits, qualifying site assessments, initiation, interim and closeout.
- Assist in the identification/evaluation of investigators and sites.
- Prepares and initiates Confidentiality Agreements.
- Assist in preparation of Clinical Site Agreements, including negotiation of site budgets.
- Assist in investigator and study staff training.
- Develop informed consent templates.
- Manage investigative sites.
- Track and report study site progress.
- Review and sign-off on investigator payments.
- Co-monitors as needed.
- Mentors less experienced Clinical Research Associates.
- Manages, coordinates, attends and participates in investigator and coordinator meetings.
- Participate and/or chair team meetings.
- Provides centralized site support, communication and coordination to assure accurate and timely completion of all contracted activities.
- Provides ongoing site management support through project completion.
- Facilitate general communication among the research centers, project teams, sponsors and site monitors relative to the responsibilities itemized above.
Secondary Duties:
- Review proposals, budgets and contracts.
- Create timelines.
- Track milestones.
- Facilitate all internal and external communication.
- May be called upon to perform Clinical Site Manager tasks.
Requirements: Education:
BS Degree in science/health related field required; Masters degree preferred
Years of related experience:
At least 5 years clinical research experience required in a pharmaceutical, biotech or CRO setting with a minimum of 2 years of independent clinical monitoring required.
Travel: Approximately 25-30% Travel will be required, to attend Investigator Meetings, Site Visits, Professional Conferences
Required Skills for Lead CRA, Low Local Travel Job:
CLINICAL MONITORING
CLINICAL SITE MONITORING
LEAD CRA
About Aerotek Scientific:
Join 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 are equal opportunity employers.
Contact Information
Stefanie A Carrabba Apply Now! Begin by filling out the "Apply Online for this Job" section at the top of the page Need Directions? Get office driving directions with Google Maps .
scarrabb@aerotek.com .
Aerotek Scientific - Boston North, MA .
100 Unicorn Park Drive
Woburn, MA 01801 .
TEL: (781) 938-3037
FAX: (781) 938-3090
Applicant Category: Professional
Requisition Code: Work at home
Two Initials of Recruiter: bw
System Date: 03/29/2007
System Time: 11:36:18
Document Name(40): Lead CRA, Low Local Travel
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