Senior Site Start up Associate / Senior Clinical Research Associate (hybrid)

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You'll be Doing:

• Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Assists with EC/IRB or CA issue resolution at the country level.

• Prepares ongoing submissions, amendments, and periodic notifications (including safety reporting) required by central and local EC/IRB and RA, and other local regulatory authorities as needed within the country, as required by local rules. Submits end of study notifications to RAs, ECs/IRBs and other local authorities in the specified country according to national timelines.

• Performs/oversees essential document collection and review, ensuring that sponsor and investigator obligations are being met and comply with applicable local regulatory requirements and ICH/GCP guidelines.

• Local Investigator Contract and budget negotiator (where applicable) produces site-specific contracts from country template.  Submit proposed contract and budget to the site for review.  Negotiates budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution.

• Conducts the site identification process by contacting sites to confirm the investigator’s interest and eligibility to participate in a clinical trial protocol. Liaises with the Site Identification Lead to assist the Medical Information team with site outreach for pre-award assessments as needed.

• Delivering quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines

• Countrywide monitoring (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations

What we are searching for:

• Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional

• 3-5 years’ experience as a SSUA or in the submission of local clinical trial applications.

• Experience of contracts and budget negotiation.

• Broad experience working on different study types/phases such as interventional IMP studies, non-interventional studies, medical Device studies, GMO studies, and observational studies.

• Thorough knowledge of FDA Guidance Documents / EU Directives/Regulations / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures.

Please note, this is a contractor position for a hybrid Senior Site Start Up Associate & Clinical Research Associate role with an anticipated split of 60% Start Up : 40% CRA activities. Successful candidates should be available for an immediate start.

The position will be offered as a full FTE with a 1-year contract duration.