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GEHC - Clinical Specialist I
Ref No.: 18-02970
Location: Marlborough, Massachusetts
Start Date / End Date: 05/07/2018 to 05/06/2019
POSITION TITLE - CLINICAL SUPPORT ASSOCIATE

Key responsibilities/essential functions include (but are not limited to):

1. Assist the GxP Operation team with the inspection readiness of TMF/eTMF records for clinical studies; work with internal staff as necessary for document reconciliation
2. Assist the archivist with tracking and transfer of paper records to off-site archives for permanent storage
3. Assist with retrieval and return of legacy Clinical Trials documentation at offsite storage facilities
4. Assist with management of TMF regulatory documents associated with clinical supplies. Work closely with Client Clinical Support Analyst and vendor to assure filing of documents into TMF/eTMF.
5. Perform scanning of clinical trial and training documentation for electronic filing and storage.


Quality Specific Goals:

1. Awareness and compliance with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
2. Completion of all planned Quality & Compliance training with the defined deadlines.
3. Identify and report any quality or compliance concerns and take immediate corrective action as required.
4. Participation in continuous improvement activities by driving the implementation of process quality improvement initiatives when possible.

Qualifications/Requirements:

1. 0-2 years experience in clinical trials management and systems management within the pharmaceutical biotech or healthcare industry.
2. Excellent communication and interpersonal skills and ability to work in a team.
3. Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.
4. Must be willing to work in our Marlborough, MA office.


Desired Characteristics:

1. Prior knowledge of the clinical trials process and Good Clinical Practices.
2. Well organized and structured, attention to detail.
3. Able to work independently and systematically on multiple tasks.
4. Diplomatic, cooperative team worker.
5. Ability to prioritize assignments and deliver according to defined milestones & multiple projects.
6. Able to work well independently as well as function as a cohesive member of a team.
7. Proficient with Microsoft Word and Excel.
8. Strong attention to detail and understands importance of timelines; strives to adhere to and meet deadlines.

Does the position allow for the worker to be virtual/remote?
No
Shore Options Available for this Position
Onshore Only
Hours per Day 8
Hours per Week 40
Total Hours 2,088.00