Senior CRA (SCRA) with at least four years’ experience required on the East Coast for exclusive opportunity with Barrington James.
My client is a large, well known CRO that offers an exceptional rewards package and competitive salary. Seeking to expand their global structure, my client is looking for Senior Clinical Research Associates with at least four years’ in the industry and full clinical trial cycle experience. Furthermore, if you feel that current role doesn’t offer you the recognition that you desire then please apply – this company offers an outstanding recognition programme.
Primary Key Responsibilities:
- Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and SOPs for monitoring requirements.
- Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
- Collects and reviews regulatory documents as required.
- Prepares site visit reports and telephone contact reports.
- May participate in the start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, and developing study documents.
- Resolves site issues, including site recruitment challenges and determines status for IP shipment.
- Works with Project Manager (PM), Clinical Team Leader and/or LCRA (CTL/LCRA), regulatory team members or sponsors to secure authorization of regulatory documents and site contracts.
- Informs team members of completion of regulatory and contractual documents for individual sites.
- Attends Investigator Meetings (IM) and study specific training meetings.
- May translate, coordinate translations or review completed translations of critical documents.
- May participate in feasibility and/or site identification activities. Contact local opinion leaders, medical consultants or specified investigators and identify sites with the potential for participation. Follows the feasibility procedures for documentation of feasibilities performed.
- Performs internal in-house monitoring tasks.
- Prepares and attends an Assessment Visit with a more senior CRA, Clinical Team Leader or Clinical Research Manager as required.
- Assists the Project Team with the day-to-day management of clinical studies as required, including attendance at team meetings.
Education Requirements and Qualifications:
- Relevant life science medical / nursing degree or relevant degree or background preferred.
- Customer service orientation.
- Sound knowledge of medical terminology and clinical monitoring process.
- Ability to perform travel an average of 65%, depending on project needs.
- Excellent communication in English in both written and verbal skills.
- Computer literate and proficient in Microsoft Office.
- Excellent interpersonal and organizational skills.
- Ability to work independently and to effectively prioritize tasks.
- Ability to manage multiple projects/tasks, establish and maintain strong working relationships with co-workers, managers, investigators, site personnel and clients
STRONG experience in Women's Health required.
In return, you will receive:
- Industry lead training
- Flexible work hours,
- Great career progression
- Impressive benefits package.
- This role will expose the candidate to a whole range of therapeutic areas, building on previous experience and expanding your career progression.
Here at Barrington James we are more than just your usual recruitment company. We are a well-established pharmaceutical specialist with over 12 years of proven delivery experience. We have a Global Reach – Our service Extends throughout Europe, Asia, The USA. If you have any questions or queries, or would like some advice on how to further your career, it would be a pleasure of mine to help in any situation.
If you are interested in this role please contact me directly at firstname.lastname@example.org / +1 646 415 8221