Sr. Clinical Research Associate

We are a well established consulting firm that provides solutions to medical device company, pharmaceuticals and biologics.

Opportunity to wear different hats in a small company-lots of growth!
Strong benefits and compensation package
Opportunity to work in multiple therapeutic and diagnostic areas

Job Details:

Are you passionate about making a significant contribution to the world of science? We are seeking a dedicated and dynamic full time Sr. Clinical Research Associate (CRA) to join our team. The successful candidate will play a pivotal role in the execution of clinical trials, ensuring the integrity of data and adherence to regulatory guidelines. This role offers a fantastic opportunity to work at the forefront of scientific research, working with leading biotechnology, pharmaceutical, and medical device companies.

Responsibilities:

As a Sr. CRA, your primary responsibilities will include:

• Conducting site visits to assess protocol and regulatory compliance, reviewing Case Report Forms (CRFs), and communicating findings with site staff.
• Collaborating with the clinical trial team to develop trial protocols, data collection systems, and final reports.
• Ensuring study activities align with Good Clinical Practice (GCP) guidelines and all relevant regulatory requirements.
• Coordinating with the clinical trial sites to ensure timely initiation, monitoring, and completion of clinical trials.
• Reviewing and reporting on the progress of studies, including site monitoring reports and enrollment status.
• Participating in the preparation of regulatory submissions (IND, NDA).
• Facilitating communication between clinical sites, laboratories, and vendors to ensure the smooth running of the trial.
• Assisting in the development and implementation of patient recruitment strategies.

Qualifications:

To be considered for this exciting opportunity, you will need:

• Bachelor's degree in a scientific or health-related field.
• Minimum 3 years of experience as a Clinical Research Associate or in a similar role within the biotechnology, pharmaceutical, or medical device industry.
• Proven experience in clinical trials, including site monitoring, study maintenance, and report writing.
• Familiarity with regulatory guidelines such as IND and NDA submissions and Good Clinical Practice (GCP).
• Excellent communication and interpersonal skills, with the ability to build strong relationships with trial site staff and internal team members.
• Strong organizational skills, with the ability to manage multiple projects and meet deadlines.
• Willingness to travel as required for site visits, around 50% or so

Join us and contribute to advancing scientific knowledge and improving patient outcomes. We offer a competitive compensation package and a collaborative, innovative work environment. If you have a passion for science and a commitment to excellence, we would love to hear from you.